Trial Outcomes & Findings for Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease (NCT NCT00975195)
NCT ID: NCT00975195
Last Updated: 2015-02-10
Results Overview
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
2488 participants
Primary outcome timeframe
During randomised treatment, up to 488 days
Results posted on
2015-02-10
Participant Flow
Participant milestones
| Measure |
Fluticasone Maintenance
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
Fluticasone Withdrawal
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
|---|---|---|
|
Overall Study
STARTED
|
1244
|
1244
|
|
Overall Study
COMPLETED
|
1016
|
1011
|
|
Overall Study
NOT COMPLETED
|
228
|
233
|
Reasons for withdrawal
| Measure |
Fluticasone Maintenance
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
Fluticasone Withdrawal
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
|---|---|---|
|
Overall Study
Adverse Event
|
108
|
101
|
|
Overall Study
Lack of Efficacy
|
6
|
6
|
|
Overall Study
Protocol Violation
|
27
|
23
|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
|
Overall Study
Withdrawal by Subject
|
48
|
61
|
|
Overall Study
Other reason not defined above
|
29
|
33
|
|
Overall Study
Not treated
|
1
|
2
|
Baseline Characteristics
Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Total
n=2485 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.6 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
64.0 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 8.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
230 Participants
n=5 Participants
|
206 Participants
n=7 Participants
|
436 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1013 Participants
n=5 Participants
|
1036 Participants
n=7 Participants
|
2049 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated set
A Chronic Obstructive Pulmonary Disease (COPD) exacerbation was defined as an increase or new onset of ≥2 lower respiratory symptoms related to COPD, with ≥1 symptom lasting ≥3 days, requiring a change in treatment. Lower respiratory symptoms included shortness of breath, sputum production (volume), sputum purulence, cough, wheezing and chest tightness. A change in treatment included: hospitalisation/treatment in an urgent care unit, prescription of antibiotics and/or systemic steroids or a significant change of prescribed respiratory medication such as theophyllines, long-acting beta-agonists or inhaled corticosteroids. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.The "measure type" displays the 25th percentile and its 95% confidence interval.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Time to First Moderate or Severe On-treatment COPD Exacerbation
|
110.0 days
Interval 99.0 to 120.0
|
107.0 days
Interval 94.0 to 124.0
|
SECONDARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated Set
Number of moderate or severe on-treatment COPD exacerbations, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as moderate or severe if ≥1 of the contributing exacerbation events was moderate or severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids. Measured values show adjusted mean event rate.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Number of Moderate or Severe On-treatment COPD Exacerbations
|
0.95 exacerbations per patient-year
Interval 0.87 to 1.04
|
0.91 exacerbations per patient-year
Interval 0.83 to 0.99
|
SECONDARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated set
Presence (yes vs no) of at least one moderate or severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Exacerbations were considered moderate if they required prescription of antibiotics and/or systemic steroids.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Proportion of Patients With ≥1 Moderate or Severe On-treatment COPD Exacerbation
|
46.7 percentage of participants
|
44.2 percentage of participants
|
SECONDARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated set
Time to first severe on-treatment COPD exacerbation. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. The "measure type" displays the 25th percentile and its 95% confidence interval.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Time to First Severe On-treatment COPD Exacerbation
|
419.0 days
Interval 379.0 to
Not estimable as not enough events during the timeframe.
|
NA days
Not estimable as not enough events during the timeframe.
|
SECONDARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated set
Number of severe on-treatment COPD exacerbations based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined and counted as severe if ≥1 of the contributing exacerbation events was severe. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital. Measured values show adjusted event rate.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Number of Severe On-treatment COPD Exacerbations
|
0.23 exacerbations per patient-year
Interval 0.19 to 0.27
|
0.20 exacerbations per patient-year
Interval 0.17 to 0.23
|
SECONDARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated set
Presence (yes vs no) of at least one severe on-treatment COPD exacerbation, displayed as a percentage. Exacerbations were considered severe if the patient was held and treated for an acute respiratory condition in an urgent care department or an observation unit for \>6 hours, the patient was treated at home by a mobile urgent care team or the patient was admitted to hospital.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Proportion of Patients With at Least One Severe On-treatment COPD Exacerbation.
|
15.2 percentage of participants
|
13.4 percentage of participants
|
SECONDARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated set
Time to first on-treatment COPD exacerbation of any severity. The "measure type" displays the 25th percentile and its 95% confidence interval.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Time to First On-treatment COPD Exacerbation
|
346.0 days
Interval 302.0 to
Not estimable as not enough events during the timeframe.
|
365.0 days
Interval 309.0 to
Not estimable as not enough events during the timeframe.
|
SECONDARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated set
Number of on-treatment COPD exacerbations of any severity, based on a 7-day gap rule: exacerbations where the onset date of the second exacerbation event was ≤7 days after the end date of the first exacerbation event were combined. Measured values show adjusted event rate.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Number of On-treatment COPD Exacerbations
|
1.08 exacerbations per patient-year
Interval 0.99 to 1.17
|
1.03 exacerbations per patient-year
Interval 0.95 to 1.12
|
SECONDARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated set
Presence (yes vs no) of at least one on-treatment COPD exacerbation of any severity, displayed as a percentage.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Proportion of Patients With at Least One On-treatment COPD Exacerbation
|
49.0 percentage of participants
|
46.9 percentage of participants
|
SECONDARY outcome
Timeframe: During randomised treatment, up to 488 daysPopulation: Treated set
Severity of on-treatment COPD exacerbations: for each patient, the worst applicable category was taken (i.e. none, mild, moderate or severe)
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Severity of On-treatment COPD Exacerbations
Moderate
|
31.5 percentage of participants
|
30.8 percentage of participants
|
|
Severity of On-treatment COPD Exacerbations
Severe
|
15.2 percentage of participants
|
13.4 percentage of participants
|
|
Severity of On-treatment COPD Exacerbations
None and patient completed randomised treatment
|
41.2 percentage of participants
|
42.9 percentage of participants
|
|
Severity of On-treatment COPD Exacerbations
None and patient discontinued randomised treatment
|
9.8 percentage of participants
|
10.2 percentage of participants
|
|
Severity of On-treatment COPD Exacerbations
Mild
|
2.3 percentage of participants
|
2.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 6, 12, 18 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment lung function as measured by trough forced expiratory volume in one second (FEV1); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment Lung Function as Measured by Trough FEV1
Week 6 visit (N=1135, 1135)
|
-0.011 Litres
Standard Error 0.0062
|
-0.009 Litres
Standard Error 0.0062
|
|
Change in On-treatment Lung Function as Measured by Trough FEV1
Week 12 visit (N=1114, 1092)
|
-0.018 Litres
Standard Error 0.0063
|
-0.011 Litres
Standard Error 0.0062
|
|
Change in On-treatment Lung Function as Measured by Trough FEV1
Week 18 visit (N=1077, 1058)
|
-0.050 Litres
Standard Error 0.0064
|
-0.011 Litres
Standard Error 0.0064
|
|
Change in On-treatment Lung Function as Measured by Trough FEV1
Week 52 visit (N=970, 935)
|
-0.059 Litres
Standard Error 0.0096
|
-0.016 Litres
Standard Error 0.0094
|
SECONDARY outcome
Timeframe: Baseline and week 18 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment dyspnoea as measured by the Modified Medical Research Council (MMRC) dyspnoea scale; change was calculated as week score minus baseline score. Negative changes from baseline indicate an improvement in health. Scale from 0 to 4: * 0 = not troubled by breathlessness, except during strenuous exercise * 1 = short of breath when hurrying or walking up a slight hill * 2 = walks slower than contemporaries on the same level because of breathlessness, or has to stop for breath when walking at own pace * 3 = stops for breath after approximately 100 yards, or after a few minutes on the level * 4 = too breathless to leave the house, or breathless when dressing or undressing "No breathlessness" was given a score of -1 Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
Week 18 visit (N=1140, 1143)
|
-0.001 units on a scale
Standard Error 0.022
|
-0.030 units on a scale
Standard Error 0.022
|
|
Changes in On-treatment Dyspnoea as Measured by the Modified Medical Research Council (MMRC) Dyspnoea Scale
Week 52 visit (N=1043, 1019)
|
0.035 units on a scale
Standard Error 0.024
|
-0.028 units on a scale
Standard Error 0.024
|
SECONDARY outcome
Timeframe: Baseline and week 18 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment physical health status as determined by body mass index (BMI); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
Week 18 visit (N=1143, 1146)
|
0.040 kg/m2
Standard Error 0.028
|
0.030 kg/m2
Standard Error 0.028
|
|
Change in On-treatment Physical Health Status as Determined by Body Mass Index (BMI)
Week 52 visit (N=1047, 1021)
|
-0.009 kg/m2
Standard Error 0.039
|
0.004 kg/m2
Standard Error 0.039
|
SECONDARY outcome
Timeframe: Baseline and week 18 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment exercise capacity measured by six-minute walk test (6-MWT); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
Week 18 visit (N=1111, 1110)
|
1.94 meters
Standard Error 1.993
|
3.89 meters
Standard Error 1.993
|
|
Change in On-treatment Exercise Capacity Measured by Six-minute Walk Test (6-MWT)
Week 52 visit (N=1013, 987)
|
0.42 meters
Standard Error 2.252
|
3.94 meters
Standard Error 2.231
|
SECONDARY outcome
Timeframe: Baseline and week 18 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment BODE index (Body mass index, airflow Obstruction, Dyspnea and Exercise capacity index), a composite score ranging from 0 (best) to 10 (worst); change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment BODE Index
Week 18 visit (N=1038, 1024)
|
0.06 units on a scale
Standard Error 0.03
|
-0.06 units on a scale
Standard Error 0.03
|
|
Change in On-treatment BODE Index
Week 52 visit (N=931, 907)
|
0.14 units on a scale
Standard Error 0.04
|
-0.03 units on a scale
Standard Error 0.04
|
SECONDARY outcome
Timeframe: Baseline and week 12, 18 and 52 visitsPopulation: Treated set who completed CASA-Q
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=361 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=364 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
Week 12 visit (N=307, 319)
|
-1.24 units on a scale
Standard Error 0.968
|
-1.65 units on a scale
Standard Error 0.986
|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
Week 18 visit (N=302, 312)
|
-3.71 units on a scale
Standard Error 1.018
|
-2.87 units on a scale
Standard Error 1.035
|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Impact Domain
Week 52 visit (N=268, 269)
|
-5.54 units on a scale
Standard Error 1.057
|
-4.51 units on a scale
Standard Error 1.063
|
SECONDARY outcome
Timeframe: Baseline and week 12, 18 and 52 visitsPopulation: Treated set who completed CASA-Q
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Cough symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to cough. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=361 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=364 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
Week 12 visit (N=309, 318)
|
-0.85 units on a scale
Standard Error 1.048
|
-0.32 units on a scale
Standard Error 1.062
|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
Week 18 visit (N=305, 312)
|
-3.34 units on a scale
Standard Error 1.091
|
-1.47 units on a scale
Standard Error 1.103
|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Cough Symptoms Domain
Week 52 visit (N=270, 268)
|
-3.26 units on a scale
Standard Error 1.180
|
-1.69 units on a scale
Standard Error 1.180
|
SECONDARY outcome
Timeframe: Baseline and week 12, 18 and 52 visitsPopulation: Treated set who completed CASA-Q
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum impact domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "a lot/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less impact due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=361 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=364 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
Week 12 visit (N=308, 317)
|
-1.63 units on a scale
Standard Error 0.983
|
-2.26 units on a scale
Standard Error 0.996
|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
Week 18 visit (N=303, 310)
|
-3.31 units on a scale
Standard Error 0.967
|
-2.38 units on a scale
Standard Error 0.977
|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Impact Domain
Week 52 visit (N=267, 267)
|
-4.15 units on a scale
Standard Error 1.045
|
-4.29 units on a scale
Standard Error 1.047
|
SECONDARY outcome
Timeframe: Baseline and week 12, 18 and 52 visitsPopulation: Treated set who completed CASA-Q
Change from baseline in on-treatment cough and expectoration as measured by the cough and sputum assessment questionnaire (CASA-Q) (selected sites only): Sputum symptoms domain. Change was calculated as week score minus baseline score. Response options for the items in this domain range from "not at all/never" to "extremely/always" on a five-point scale. Domain items were reverse scored, summed and transformed to a domain score ranging from 0 to 100 where a higher score is associated with less symptoms due to sputum. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=361 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=364 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
Week 12 visit (N=308, 317)
|
-1.24 units on a scale
Standard Error 1.139
|
-1.36 units on a scale
Standard Error 1.154
|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
Week 18 visit (N=302, 311)
|
-1.93 units on a scale
Standard Error 1.105
|
-2.71 units on a scale
Standard Error 1.119
|
|
Change in On-treatment Cough and Expectoration as Measured by the CASA-Q: Sputum Symptoms Domain
Week 52 visit (N=269, 268)
|
-2.45 units on a scale
Standard Error 1.211
|
-5.10 units on a scale
Standard Error 1.212
|
SECONDARY outcome
Timeframe: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment Forced Expiratory Volume in One Second (FEV1) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Week 6 visit (N=893, 939)
|
-0.053 Litres
Standard Error 0.0065
|
-0.049 Litres
Standard Error 0.0066
|
|
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Week 12 visit (N=910, 930)
|
-0.056 Litres
Standard Error 0.0067
|
-0.050 Litres
Standard Error 0.0068
|
|
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Week 18 visit (N=913, 901)
|
-0.093 Litres
Standard Error 0.0068
|
-0.051 Litres
Standard Error 0.0068
|
|
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Week 27 visit (N=863, 843)
|
-0.092 Litres
Standard Error 0.0072
|
-0.056 Litres
Standard Error 0.0071
|
|
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Week 36 visit (N=854, 845)
|
-0.099 Litres
Standard Error 0.0074
|
-0.059 Litres
Standard Error 0.0074
|
|
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Week 45 visit (N=830, 815)
|
-0.103 Litres
Standard Error 0.0080
|
-0.061 Litres
Standard Error 0.0080
|
|
Change in On-treatment FEV1 as Measured by Home Based Spirometry
Week 52 visit (N=785, 788)
|
-0.115 Litres
Standard Error 0.0087
|
-0.067 Litres
Standard Error 0.0087
|
SECONDARY outcome
Timeframe: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment forced vital capacity (FVC) as measured by home based spirometry. Change was calculated as week score minus baseline score. The weekly mean was defined as the mean of the measurements taken during the last 7 days prior to the visit date, and was calculated if ≥4 of the 7 days had non-missing measurements. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment FVC as Measured by Home Based Spirometry
Week 6 visit (N=893, 939)
|
-0.089 Litres
Standard Error 0.0177
|
-0.116 Litres
Standard Error 0.0179
|
|
Change in On-treatment FVC as Measured by Home Based Spirometry
Week 12 visit (N=910, 930)
|
-0.105 Litres
Standard Error 0.0167
|
-0.113 Litres
Standard Error 0.0168
|
|
Change in On-treatment FVC as Measured by Home Based Spirometry
Week 18 visit (N=913, 901)
|
-0.124 Litres
Standard Error 0.0177
|
-0.122 Litres
Standard Error 0.0177
|
|
Change in On-treatment FVC as Measured by Home Based Spirometry
Week 27 visit (N=863, 843)
|
-0.147 Litres
Standard Error 0.0167
|
-0.123 Litres
Standard Error 0.0167
|
|
Change in On-treatment FVC as Measured by Home Based Spirometry
Week 36 visit (N=854, 845)
|
-0.158 Litres
Standard Error 0.0171
|
-0.135 Litres
Standard Error 0.0170
|
|
Change in On-treatment FVC as Measured by Home Based Spirometry
Week 45 visit (N=830, 815)
|
-0.168 Litres
Standard Error 0.0175
|
-0.141 Litres
Standard Error 0.0174
|
|
Change in On-treatment FVC as Measured by Home Based Spirometry
Week 52 visit (N=785, 788)
|
-0.201 Litres
Standard Error 0.0180
|
-0.157 Litres
Standard Error 0.0180
|
SECONDARY outcome
Timeframe: Baseline and week 6, 12, 18, 27, 36, 45 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment peak expiratory flow rate (PEFR) as measured by home based spirometry; change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment PEFR as Measured by Home Based Spirometry
Week 12 visit (N=910, 930)
|
-0.290 Litres/sec
Standard Error 0.0252
|
-0.266 Litres/sec
Standard Error 0.0253
|
|
Change in On-treatment PEFR as Measured by Home Based Spirometry
Week 6 visit (N=893, 939)
|
-0.230 Litres/sec
Standard Error 0.0246
|
-0.228 Litres/sec
Standard Error 0.0249
|
|
Change in On-treatment PEFR as Measured by Home Based Spirometry
Week 18 visit (N=913, 901)
|
-0.435 Litres/sec
Standard Error 0.0254
|
-0.295 Litres/sec
Standard Error 0.0253
|
|
Change in On-treatment PEFR as Measured by Home Based Spirometry
Week 27 visit (N=863, 843)
|
-0.430 Litres/sec
Standard Error 0.0274
|
-0.319 Litres/sec
Standard Error 0.0273
|
|
Change in On-treatment PEFR as Measured by Home Based Spirometry
Week 36 visit (N=854, 845)
|
-0.473 Litres/sec
Standard Error 0.0278
|
-0.352 Litres/sec
Standard Error 0.0278
|
|
Change in On-treatment PEFR as Measured by Home Based Spirometry
Week 45 visit (N=830, 815)
|
-0.490 Litres/sec
Standard Error 0.0298
|
-0.368 Litres/sec
Standard Error 0.0297
|
|
Change in On-treatment PEFR as Measured by Home Based Spirometry
Week 52 visit (N=785, 788)
|
-0.538 Litres/sec
Standard Error 0.0318
|
-0.377 Litres/sec
Standard Error 0.0318
|
SECONDARY outcome
Timeframe: Baseline and week 27 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Activity domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
Week 27 visit (N=1002, 988)
|
0.85 units on a scale
Standard Error 0.496
|
0.09 units on a scale
Standard Error 0.492
|
|
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Activity Domain
Week 52 visit (N=942, 916)
|
0.78 units on a scale
Standard Error 0.518
|
-0.19 units on a scale
Standard Error 0.512
|
SECONDARY outcome
Timeframe: Baseline and week 27 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Impact Domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
Week 27 visit (N=1004, 998)
|
0.35 units on a scale
Standard Error 0.457
|
-0.78 units on a scale
Standard Error 0.456
|
|
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Impact Domain
Week 52 visit (N=946, 921)
|
1.27 units on a scale
Standard Error 0.499
|
-0.08 units on a scale
Standard Error 0.494
|
SECONDARY outcome
Timeframe: Baseline and week 27 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Symptoms domain. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
Week 27 visit (N=1010, 998)
|
0.62 units on a scale
Standard Error 0.586
|
0.12 units on a scale
Standard Error 0.583
|
|
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Symptoms Domain
Week 52 visit (N=955, 921)
|
1.11 units on a scale
Standard Error 0.602
|
0.51 units on a scale
Standard Error 0.593
|
SECONDARY outcome
Timeframe: Baseline and week 27 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment St Georges Respiratory Questionnaire (SGRQ) scores: Total score. Scores range from 0 to 100, with higher scores indicating more limitations. Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
Week 27 visit (N=996, 986)
|
0.55 units on a scale
Standard Error 0.401
|
-0.42 units on a scale
Standard Error 0.398
|
|
Change in On-treatment St Georges Respiratory Questionnaire (SGRQ) Scores: Total Score
Week 52 visit (N=939, 913)
|
1.15 units on a scale
Standard Error 0.437
|
-0.07 units on a scale
Standard Error 0.432
|
SECONDARY outcome
Timeframe: Baseline and week 27 and 52 visitsPopulation: Treated set
Change from baseline in on-treatment physician global evaluation. The evaluation reflected the physician's opinion of the patient's overall condition and was based on the need for concomitant medication, the number and severity of exacerbations, the severity of cough, the ability to exercise, the amount of wheezing and any other relevant clinical observations. Patients were graded on a scale of 1 (poor) to 8 (excellent). Change was calculated as week score minus baseline score. Statistical analysis results are presented only for the week 52 visit as this is the primary timepoint of interest.
Outcome measures
| Measure |
Fluticasone Withdrawal
n=1242 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
Fluticasone Maintenance
n=1243 Participants
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
|---|---|---|
|
Change in On-treatment Physician Global Evaluation
Week 27 visit (N=1113, 1093)
|
0.04 units on a scale
Standard Error 0.03
|
0.10 units on a scale
Standard Error 0.03
|
|
Change in On-treatment Physician Global Evaluation
Week 52 visit (N=1041, 1014)
|
0.08 units on a scale
Standard Error 0.03
|
0.19 units on a scale
Standard Error 0.03
|
Adverse Events
Fluticasone Maintenance
Serious events: 292 serious events
Other events: 464 other events
Deaths: 0 deaths
Fluticasone Withdrawal
Serious events: 300 serious events
Other events: 458 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fluticasone Maintenance
n=1243 participants at risk
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
Fluticasone Withdrawal
n=1242 participants at risk
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Acute coronary syndrome
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Acute myocardial infarction
|
0.40%
5/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Angina pectoris
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Angina unstable
|
0.32%
4/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Aortic valve disease
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Arrhythmia
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.72%
9/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.40%
5/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Atrial flutter
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Bundle branch block right
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cardiac arrest
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.32%
4/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cardiac asthma
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cardiac disorder
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cardiac failure
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cardiac failure acute
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cardiac failure congestive
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cor pulmonale
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Cor pulmonale chronic
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Coronary artery disease
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Coronary artery stenosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Hypertensive heart disease
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Myocardial infarction
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Myocardial ischaemia
|
0.32%
4/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Right ventricular failure
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Sinus bradycardia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Eye disorders
Angle closure glaucoma
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Eye disorders
Cataract
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.32%
4/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Eye disorders
Pterygium
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Eye disorders
Visual impairment
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Colonic stenosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Constipation
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Melaena
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Oesophageal food impaction
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Pancreatitis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Salivary gland calculus
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
General disorders
Chest pain
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
General disorders
Death
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
General disorders
Impaired healing
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
General disorders
Inflammation
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
General disorders
Oedema
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
General disorders
Oedema peripheral
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
General disorders
Sudden cardiac death
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
General disorders
Sudden death
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Appendicitis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Arthritis bacterial
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Aspergillosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Bronchitis
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Chronic sinusitis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Device related infection
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Ear infection
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Erysipelas
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Escherichia infection
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Extradural abscess
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Gastroenteritis
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Gastrointestinal infection
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.56%
7/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.40%
5/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Klebsiella infection
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Liver abscess
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Lobar pneumonia
|
0.97%
12/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Lower respiratory tract infection
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Lung infection
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Meningitis viral
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Pneumonia
|
2.7%
34/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
3.1%
38/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Pneumonia klebsiella
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Pseudomonal sepsis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Pyelonephritis acute
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Pyelonephritis chronic
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Respiratory tract infection
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Sepsis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Septic shock
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Tuberculosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Urinary tract infection
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Vestibular neuronitis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Infections and infestations
Wound infection
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Avulsion fracture
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Back injury
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Bronchitis chemical
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Carbon monoxide poisoning
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Fracture
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Graft thrombosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Injury
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Laceration
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Urethral injury
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Injury, poisoning and procedural complications
Wound
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Investigations
Angiogram
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Investigations
Blood pressure decreased
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Investigations
Hepatic enzyme increased
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Investigations
Pulmonary function test decreased
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Investigations
Weight decreased
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon neoplasm
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage III
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.40%
5/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Maxillofacial sinus neoplasm
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Vocal cord neoplasm
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Carotid artery stenosis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Cerebellar infarction
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Cerebral arteriosclerosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Cerebral infarction
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Cerebrovascular accident
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Convulsion
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Intercostal neuralgia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Ischaemic stroke
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Meningorrhagia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Radiculitis cervical
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Sciatica
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Psychiatric disorders
Bipolar I disorder
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Psychiatric disorders
Depression
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Psychiatric disorders
Panic attack
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Calculus ureteric
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Focal segmental glomerulosclerosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Mesangioproliferative glomerulonephritis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Proteinuria
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Renal failure
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Renal failure chronic
|
0.32%
4/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Renal impairment
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Renal and urinary disorders
Urinary retention
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.40%
5/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
12.4%
154/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
14.5%
180/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.32%
4/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.24%
3/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal leukoplakia
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.72%
9/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.81%
10/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Surgical and medical procedures
Alcohol detoxification
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Surgical and medical procedures
Angioplasty
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Surgical and medical procedures
Oxygen supplementation
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Aortic aneurysm
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Aortic thrombosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Arterial occlusive disease
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.16%
2/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Hypertension
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.24%
3/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Hypertensive emergency
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Intermittent claudication
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Peripheral ischaemia
|
0.16%
2/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Phlebitis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Subclavian artery stenosis
|
0.00%
0/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.08%
1/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Thrombosis
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Vascular disorders
Venous thrombosis limb
|
0.08%
1/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
0.00%
0/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
Other adverse events
| Measure |
Fluticasone Maintenance
n=1243 participants at risk
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
|
Fluticasone Withdrawal
n=1242 participants at risk
18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.5%
93/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
6.4%
80/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
33.0%
410/1243 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
33.3%
413/1242 • Randomised treatment plus 30 days post-treatment for patients not switching to open-label, up to 518 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim Pharmaceuticals
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER