Trial Outcomes & Findings for The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01490125)
NCT ID: NCT01490125
Last Updated: 2013-12-24
Results Overview
Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.
COMPLETED
PHASE3
247 participants
Baseline and 6 weeks
2013-12-24
Participant Flow
247 patients were randomized. Of these 247, one patient was misrandomized, did not receive study treatment and was excluded from any analysis set. Of 246 patients, 191 completed the study. This is a crossover study; therefore, participants are counted more than once depending on their dosing sequences.
Participants were randomized to 1 of 6 treatment sequences to receive 1 of 3 treatment combinations; then, crossed to the other 2 possible treatment combinations for a total of 3 treatment periods. Each treatment combination period was followed by a 14 day washout.
Participant milestones
| Measure |
QVA149+ Placebo+ Tiotropium
Participants were randomized to sequence QVA149 + placebo + tiotropium.
|
QVA149+ Tiotropium+ Placebo
Participants were randomized to sequence QVA149 + tiotropium + placebo.
|
Placebo + QVA149 + Tiotropium
Participants were randomized to sequence placebo + QVA149 + tiotropium
|
Placebo+ Tiotropium + QVA149
Participants were randomized to sequence placebo + tiotropium + QVA149
|
Tiotropium + QVA149+ Placebo
Participants were randomized to sequence tiotropium + QVA149 + placebo
|
Tiotropium + Placebo +QVA149
Participants were randomized to sequence tiotropium + placebo + QVA149
|
|---|---|---|---|---|---|---|
|
Period I
STARTED
|
43
|
42
|
41
|
38
|
40
|
42
|
|
Period I
COMPLETED
|
37
|
37
|
37
|
33
|
36
|
37
|
|
Period I
NOT COMPLETED
|
6
|
5
|
4
|
5
|
4
|
5
|
|
Period II
STARTED
|
37
|
37
|
37
|
33
|
36
|
37
|
|
Period II
COMPLETED
|
34
|
33
|
34
|
30
|
32
|
35
|
|
Period II
NOT COMPLETED
|
3
|
4
|
3
|
3
|
4
|
2
|
|
Period III
STARTED
|
34
|
33
|
34
|
30
|
32
|
35
|
|
Period III
COMPLETED
|
31
|
32
|
34
|
28
|
31
|
35
|
|
Period III
NOT COMPLETED
|
3
|
1
|
0
|
2
|
1
|
0
|
Reasons for withdrawal
| Measure |
QVA149+ Placebo+ Tiotropium
Participants were randomized to sequence QVA149 + placebo + tiotropium.
|
QVA149+ Tiotropium+ Placebo
Participants were randomized to sequence QVA149 + tiotropium + placebo.
|
Placebo + QVA149 + Tiotropium
Participants were randomized to sequence placebo + QVA149 + tiotropium
|
Placebo+ Tiotropium + QVA149
Participants were randomized to sequence placebo + tiotropium + QVA149
|
Tiotropium + QVA149+ Placebo
Participants were randomized to sequence tiotropium + QVA149 + placebo
|
Tiotropium + Placebo +QVA149
Participants were randomized to sequence tiotropium + placebo + QVA149
|
|---|---|---|---|---|---|---|
|
Period I
Adverse Event
|
4
|
1
|
1
|
3
|
2
|
4
|
|
Period I
Protocol Violation
|
1
|
1
|
1
|
1
|
0
|
0
|
|
Period I
Withdrawal by Subject
|
1
|
3
|
2
|
1
|
2
|
1
|
|
Period II
Adverse Event
|
2
|
3
|
2
|
2
|
4
|
2
|
|
Period II
Protocol Violation
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Period II
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period II
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period III
Adverse Event
|
3
|
1
|
0
|
1
|
0
|
0
|
|
Period III
Death
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period III
Lack of Efficacy
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
The Effect of QVA149 on Patient Reported Dyspnea in Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
All Participants
n=246 Participants
All participants who entered the study and were randomized to any of the 3 treatment combinations: QVA149 plus placebo to tiotropium; tiotropium plus placebo to QVA149 or placebo to QVA149 plus placebo to tiotropium.
|
|---|---|
|
Age Continuous
|
62.8 years
STANDARD_DEVIATION 8.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPopulation: The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.
Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.
Outcome measures
| Measure |
QVA149 + Placebo to Tiotropium
n=220 Participants
Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Tiotropium + Placebo to QVA149
Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Placebo
n=218 Participants
Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
|---|---|---|---|
|
Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo
BDI
|
7.34 Units on a scale
Standard Deviation 2.033
|
—
|
7.33 Units on a scale
Standard Deviation 2.206
|
|
Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Placebo
TDI
|
0.98 Units on a scale
Standard Deviation 2.666
|
—
|
-0.38 Units on a scale
Standard Deviation 2.308
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.
Total Transient Dyspnea Index (TDI) is part of the BDI/TDI questionnaire where participants indicated whether they improved or deteriorated since their Baseline Dyspnea Index (BDI). The BDI and TDI each had 3 domains: activities, tasks, and effort. BDI domains were rated from 0 (very severe) to 4 (none) and the rates summed for the total BDI score ranging from 0 to 12; the lower the score the worse the severity of dyspnea. TDI domains were rated from -6 (major deterioration) to 6 (major improvement) and the rates summed for the total TDI score ranging from -18 to 18. However, to ensure comparability with the TDI paper version, all TDI values were divided by 2 before the analysis. If data was missing or insufficient for any one of the domains a BDI/TDI was calculated. BDI = Baseline Dyspnea Index taken 75 min prior to the first dose in each treatment period. TDI = Transition Dyspnea Index taken after 6 weeks of treatment 75 min prior to the last dose in each treatment period.
Outcome measures
| Measure |
QVA149 + Placebo to Tiotropium
n=220 Participants
Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Tiotropium + Placebo to QVA149
n=217 Participants
Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Placebo
Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
|---|---|---|---|
|
Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium
TDI
|
0.98 Units on a scale
Standard Deviation 2.666
|
0.47 Units on a scale
Standard Deviation 2.184
|
—
|
|
Total Total Transient Dyspnea Index (TDI) Score After 6 Weeks of Treatment QVA149 Compared to Tiotropium
BDI
|
7.34 Units on a scale
Standard Deviation 2.033
|
7.31 Units on a scale
Standard Deviation 2.199
|
—
|
SECONDARY outcome
Timeframe: 5min-4hr at day 1 and week 6 post-dosePopulation: The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.
Forced Expiratory Volume in 1 second (FEV1) was measured with spirometry conducted according to internationally accepted standards. Measurements were taken at 5 min- 4hr post-dose of day 1 and week 6. The standardized FEV1 Area under the curve (AUC) was calculated as the sum of trapezoids divided by the length of time.
Outcome measures
| Measure |
QVA149 + Placebo to Tiotropium
n=223 Participants
Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Tiotropium + Placebo to QVA149
n=220 Participants
Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Placebo
n=218 Participants
Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
|---|---|---|---|
|
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
Day 1 (n=220,219,2117)
|
1.564 Liters
Standard Error 0.0082
|
1.496 Liters
Standard Error 0.0082
|
1.352 Liters
Standard Error 0.0082
|
|
Standardized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 5min-4h After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
Week 6 (n=205,209,206)
|
1.636 Liters
Standard Error 0.0122
|
1.529 Liters
Standard Error 0.0122
|
1.302 Liters
Standard Error 0.0122
|
SECONDARY outcome
Timeframe: 5min-4hr at day 1 and week 6 post-dosePopulation: The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.
Forced Vital Capacity (FVC) is the total amount of air that can be exhaled by the patient after a full inhalation. The FVC was measured via spirometry conducted according to internationally accepted standards at 5 min-4 hr post dose of day 1 and week 6.
Outcome measures
| Measure |
QVA149 + Placebo to Tiotropium
n=223 Participants
Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Tiotropium + Placebo to QVA149
n=220 Participants
Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Placebo
n=218 Participants
Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
|---|---|---|---|
|
Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
Day 1 (n=210,219,217)
|
3.340 Liters
Standard Error 0.0190
|
3.249 Liters
Standard Error 0.0191
|
3.020 Liters
Standard Error 0.0191
|
|
Standardized Forced Vital Capacity (FVC) Area Under the Curve (AUC) 5min-4 Hrs After First Dose and 6 Weeks of Treatment With QVA149 Compared to Placebo and Tiotropium
Week 6 (n= 205,209,206)
|
3.393 Liters
Standard Error 0.0254
|
3.269 Liters
Standard Error 0.0253
|
2.957 Liters
Standard Error 0.0253
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.
The Capacity of Daily Living during the Morning (CDLM) is a self-administered daily assessment. The CDLM asks COPD patients to (i) report their ability to carry out 6 morning activities and (ii) rate the difficulty in performing those activities on a five point Likert-type scale ranging from "not at all difficult" to "extremely difficult". For each of the six morning activities a score ranging from 0 (=so difficult that they could not carry out the activity by themselves) to 5 (not at all difficult to carry out the activity by themselves) is calculated by using the responses from the two questions for each activity. Daily CDLM is calculated using the scores average from the 6 morning activities. CDLM is calculated as the average daily CDLM score over 6 weeks of treatment. The change from baseline in CDLM score over 6 weeks is analyzed using a MIXED model with baseline CDLM score as a covariate. A CDLM score of 0.20 is considered to be a minimal clinically important difference.
Outcome measures
| Measure |
QVA149 + Placebo to Tiotropium
n=167 Participants
Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Tiotropium + Placebo to QVA149
n=173 Participants
Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Placebo
n=164 Participants
Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
|---|---|---|---|
|
Change From Baseline in The Capacity of Daily Living During the Morning (CDLM) Score Averaged Over 6 Weeks of Treatment
|
0.09 Units on a scale
Standard Error 0.020
|
0.08 Units on a scale
Standard Error 0.020
|
-0.01 Units on a scale
Standard Error 0.020
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksPopulation: The analysis set includes all randomized patients who received at least one dose of study drug and for whom data are available. Data was analyzed according to the treatment they were randomized. In this cross-over design the number of patients on each treatment does not add up to the total number of patients.
The number of puffs of rescue medication taken by participants, were collected each day during the study via entries in e-diaries
Outcome measures
| Measure |
QVA149 + Placebo to Tiotropium
n=212 Participants
Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Tiotropium + Placebo to QVA149
n=215 Participants
Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Placebo
n=206 Participants
Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
|---|---|---|---|
|
Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Used Over the 6 Weeks of Treatment
|
-1.02 puffs
Standard Deviation 0.202
|
-0.57 puffs
Standard Deviation 0.202
|
0.41 puffs
Standard Deviation 0.203
|
Adverse Events
QVA149 + Placebo to Tiotropium
Tiotropium + Placebo to QVA149
Placebo
Serious adverse events
| Measure |
QVA149 + Placebo to Tiotropium
n=223 participants at risk
Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Tiotropium + Placebo to QVA149
n=220 participants at risk
Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Placebo
n=218 participants at risk
Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/223
|
0.45%
1/220
|
0.00%
0/218
|
|
Cardiac disorders
Cardiac arrest
|
0.45%
1/223
|
0.00%
0/220
|
0.00%
0/218
|
|
Cardiac disorders
Left ventricular failure
|
0.45%
1/223
|
0.00%
0/220
|
0.00%
0/218
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/223
|
0.00%
0/220
|
0.46%
1/218
|
|
General disorders
Influenza like illness
|
0.45%
1/223
|
0.00%
0/220
|
0.00%
0/218
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/223
|
0.00%
0/220
|
0.46%
1/218
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/223
|
0.45%
1/220
|
0.00%
0/218
|
|
Infections and infestations
Pleural infection bacterial
|
0.45%
1/223
|
0.00%
0/220
|
0.00%
0/218
|
|
Infections and infestations
Pneumonia
|
0.00%
0/223
|
0.45%
1/220
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Synovial cyst
|
0.45%
1/223
|
0.00%
0/220
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.00%
0/223
|
0.45%
1/220
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/223
|
0.45%
1/220
|
0.00%
0/218
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland neoplasm
|
0.45%
1/223
|
0.00%
0/220
|
0.00%
0/218
|
|
Nervous system disorders
Cerebral artery occlusion
|
0.00%
0/223
|
0.00%
0/220
|
0.46%
1/218
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/223
|
0.00%
0/220
|
0.46%
1/218
|
|
Psychiatric disorders
Alcohol abuse
|
0.00%
0/223
|
0.00%
0/220
|
0.46%
1/218
|
|
Psychiatric disorders
Depression
|
0.00%
0/223
|
0.45%
1/220
|
0.00%
0/218
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
3/223
|
0.91%
2/220
|
0.46%
1/218
|
Other adverse events
| Measure |
QVA149 + Placebo to Tiotropium
n=223 participants at risk
Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Tiotropium + Placebo to QVA149
n=220 participants at risk
Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
Placebo
n=218 participants at risk
Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/223
|
0.91%
2/220
|
0.00%
0/218
|
|
Gastrointestinal disorders
Constipation
|
0.90%
2/223
|
0.00%
0/220
|
0.00%
0/218
|
|
Gastrointestinal disorders
Diarrhoea
|
0.90%
2/223
|
0.45%
1/220
|
0.46%
1/218
|
|
Gastrointestinal disorders
Dry mouth
|
0.45%
1/223
|
0.91%
2/220
|
0.00%
0/218
|
|
Gastrointestinal disorders
Vomiting
|
0.90%
2/223
|
0.45%
1/220
|
0.00%
0/218
|
|
General disorders
Fatigue
|
0.00%
0/223
|
1.8%
4/220
|
1.4%
3/218
|
|
General disorders
Influenza like illness
|
0.90%
2/223
|
0.00%
0/220
|
0.46%
1/218
|
|
Infections and infestations
Bronchitis
|
0.00%
0/223
|
0.00%
0/220
|
0.92%
2/218
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/223
|
0.00%
0/220
|
0.92%
2/218
|
|
Infections and infestations
Influenza
|
0.00%
0/223
|
0.45%
1/220
|
1.8%
4/218
|
|
Infections and infestations
Lower respiratory tract infection
|
0.90%
2/223
|
0.45%
1/220
|
0.46%
1/218
|
|
Infections and infestations
Nasopharyngitis
|
6.3%
14/223
|
3.6%
8/220
|
6.0%
13/218
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/223
|
0.00%
0/220
|
0.92%
2/218
|
|
Infections and infestations
Sinusitis
|
0.45%
1/223
|
0.00%
0/220
|
0.92%
2/218
|
|
Infections and infestations
Upper respiratory tract infection
|
0.45%
1/223
|
0.91%
2/220
|
1.8%
4/218
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.90%
2/223
|
0.00%
0/220
|
0.46%
1/218
|
|
Infections and infestations
Urinary tract infection
|
0.90%
2/223
|
0.91%
2/220
|
0.92%
2/218
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/223
|
1.8%
4/220
|
0.00%
0/218
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/223
|
0.91%
2/220
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.90%
2/223
|
0.00%
0/220
|
0.46%
1/218
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.45%
1/223
|
0.91%
2/220
|
0.46%
1/218
|
|
Nervous system disorders
Headache
|
0.90%
2/223
|
2.7%
6/220
|
1.4%
3/218
|
|
Nervous system disorders
Sciatica
|
0.00%
0/223
|
0.00%
0/220
|
0.92%
2/218
|
|
Nervous system disorders
Somnolence
|
0.00%
0/223
|
0.00%
0/220
|
0.92%
2/218
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/223
|
0.45%
1/220
|
0.92%
2/218
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.7%
15/223
|
8.6%
19/220
|
8.7%
19/218
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
7/223
|
3.6%
8/220
|
2.3%
5/218
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/223
|
2.7%
6/220
|
4.1%
9/218
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.90%
2/223
|
0.45%
1/220
|
0.92%
2/218
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/223
|
0.00%
0/220
|
0.92%
2/218
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
0.00%
0/223
|
0.91%
2/220
|
0.00%
0/218
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.3%
3/223
|
0.45%
1/220
|
0.92%
2/218
|
|
Vascular disorders
Hypertension
|
1.3%
3/223
|
1.4%
3/220
|
1.8%
4/218
|
Additional Information
Study director
Novartis
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER