Trial Outcomes & Findings for Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.) (NCT NCT01555138)
NCT ID: NCT01555138
Last Updated: 2015-04-28
Results Overview
Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.
COMPLETED
PHASE4
581 participants
12 weeks
2015-04-28
Participant Flow
Participant milestones
| Measure |
Indacaterol
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Overall Study
STARTED
|
293
|
288
|
|
Overall Study
COMPLETED
|
246
|
250
|
|
Overall Study
NOT COMPLETED
|
47
|
38
|
Reasons for withdrawal
| Measure |
Indacaterol
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Abnormal Lab reults
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Administrative problems
|
8
|
0
|
|
Overall Study
Withdrawal by Subject
|
16
|
15
|
|
Overall Study
Adverse Event
|
14
|
14
|
Baseline Characteristics
Comparison of Indacaterol 150 mcg Once Daily (o.d.) With Salmeterol/Fluticasone Propionate 50 mcg/500 mcg Twice Daily (b.i.d.)
Baseline characteristics by cohort
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
Total
n=581 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 8.39 • n=5 Participants
|
66.8 years
STANDARD_DEVIATION 8.53 • n=7 Participants
|
66.0 years
STANDARD_DEVIATION 8.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
401 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: full analysis set
Spirometry conducted to internationally accepted standards. Trough FEV1 defined as the mean of the FEV1 measurements at 23 h 10 min and 23 h 45 min post the Day 84 morning dose. The primary variable (imputed with last observation carried forward) will be analysed using a mixed model for the Per Protocol Set (PPS). The model will contain treatment as a fixed effect with the baseline FEV1 measurement, FEV1 prior to inhalation and FEV1 10-15 min post inhalation of salbutamol (components of reversibility at Visit 1) as covariates.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Trough Forced Expiratory Volume in One Second (FEV1) at 12 Weeks (Imputed With LOCF): Treatment Comparisons
|
1.591 Liters
Standard Error 0.0276
|
1.604 Liters
Standard Error 0.0281
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full analysis set
Trough FEV1 is defined as the average of the 23 h 10 min and the 23 h 45 min values taken in the clinic at Visit 11.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Trough FEV1 (L) at Week 26 (Imputed With LOCF): Treatment Comparisons
|
1.567 Liters
Standard Error 0.0302
|
1.569 Liters
Standard Error 0.0307
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Full analysis set
FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
23h 45 min post-dose
|
1.597 Liters
Standard Error 0.0283
|
1.613 Liters
Standard Error 0.0291
|
|
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
-15 min pre-dose
|
1.623 Liters
Standard Error 0.0282
|
1.616 Liters
Standard Error 0.287
|
|
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
5 min post-dose
|
1.631 Liters
Standard Error 0.0209
|
1.613 Liters
Standard Error 0.0209
|
|
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
-50 min pre-dose
|
1.601 Liters
Standard Error 0.0281
|
1.588 Liters
Standard Error 0.0286
|
|
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
30 min post-dose,
|
1.667 Liters
Standard Error 0.0207
|
1.656 Liters
Standard Error 0.0208
|
|
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
1h post-dose,
|
1.693 Liters
Standard Error 0.0285
|
1.684 Liters
Standard Error 0.0293
|
|
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
2h post-dose
|
1.705 Liters
Standard Error 0.0291
|
1.708 Liters
Standard Error 0.0300
|
|
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
4h post-dose
|
1.670 Liters
Standard Error 0.0215
|
1.699 Liters
Standard Error 0.0216
|
|
FEV1 (L) at Individual Time Points After 12 Weeks Treatment: Treatment Comparisons
23h 10 min post-dose
|
1.577 Liters
Standard Error 0.0277
|
1.591 Liters
Standard Error 0.0284
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full analysis set
FEV1 at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group .
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
-50 min pre-dose
|
1.569 Liters
Standard Error 0.0301
|
1.582 Liters
Standard Error 0.0304
|
|
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
30 min post-dose,
|
1.670 Liters
Standard Error 0.0244
|
1.656 Liters
Standard Error 0.0244
|
|
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
1h post-dose,
|
1.676 Liters
Standard Error 0.0317
|
1.677 Liters
Standard Error 0.0324
|
|
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
2h post-dose
|
1.700 Liters
Standard Error 0.0318
|
1.693 Liters
Standard Error 0.0325
|
|
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
4h post-dose
|
1.664 Liters
Standard Error 0.0320
|
1.663 Liters
Standard Error 0.0328
|
|
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
23h 10 min post-dose
|
1.551 Liters
Standard Error 0.0305
|
1.559 Liters
Standard Error 0.0310
|
|
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
23h 45 min post-dose
|
1.574 Liters
Standard Error 0.313
|
1.575 Liters
Standard Error 0.0318
|
|
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
-15 min pre-dose
|
1.576 Liters
Standard Error 0.0294
|
1.595 Liters
Standard Error 0.0300
|
|
FEV1 (L) at Individual Time Points After 26 Weeks Treatment: Treatment Comparisons
5 min post-dose
|
1.630 Liters
Standard Error 0.0304
|
1.630 Liters
Standard Error 0.0310
|
SECONDARY outcome
Timeframe: 12 and 26 weeksPopulation: Full analysis set
FVC at each time point, for each visit, will be analyzed using the same mixed model as specified for the primary analysis. Least squares means will be displayed by treatment group.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
FVC Over 26 Weeks of Treatment
12 weeks
|
3.090 Liters
Standard Error 0.0457
|
3.064 Liters
Standard Error 0.0466
|
|
FVC Over 26 Weeks of Treatment
26 weeks
|
3.057 Liters
Standard Error 0.0512
|
3.062 Liters
Standard Error 0.0520
|
SECONDARY outcome
Timeframe: 12 and 26 weeksPopulation: Full analysis set
The standardized (with respect to the length of time) AUC for FEV1 will be calculated between 5 min and 4 h post morning dose as the sum of trapezoids divided by the length of time at Day 84 (Visit 6) and Day 182 (Visit 10). Scheduled (not actual) time points are to be used. FEV1 measurements taken within 6 h of rescue use will be set to missing before the standardized AUC is calculated.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison
Week 12
|
1.689 Liters
Standard Error 0.0201
|
1.689 Liters
Standard Error 0.0203
|
|
Analysis of AUC (5 Min - 4 h) for FEV1 (L) at Week 12 and Week 26: Treatment Comparison
Week 26
|
1.683 Liters
Standard Error 0.0304
|
1.682 Liters
Standard Error 0.0310
|
SECONDARY outcome
Timeframe: 12 and 26 weeksThe Transition Dyspnea Index (TDI) total score after 12 and 26 weeks of treatment will be analyzed using the same mixed model as specified for the primary analysis with the Baseline Dyspnea Index (BDI) total score as the baseline.Total score ranging - 9 to + 9. The lower the score, the more deterioration in severity of dyspnea. One additional option in each category, which does not contribute to the score, allows for circumstances in which impairment is due to reasons other than dyspnea.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
TDI Focal Score at Week 12 and Week 26: Treatment Comparisons
12 weeks
|
1.89 Units on a scale
Standard Error 0.499
|
1.69 Units on a scale
Standard Error 0.509
|
|
TDI Focal Score at Week 12 and Week 26: Treatment Comparisons
26 weeks
|
2.58 Units on a scale
Standard Error 0.543
|
2.70 Units on a scale
Standard Error 0.552
|
SECONDARY outcome
Timeframe: 26 weeksThe number of exacerbations during the 26 week treatment period will be analyzed using a generalized linear model assuming a negative binomial distribution.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
Greater than or equal to four
|
0 participants
|
0 participants
|
|
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
none
|
233 participants
|
215 participants
|
|
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
one
|
47 participants
|
57 participants
|
|
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
two
|
11 participants
|
15 participants
|
|
Number of COPD Exacerbations Per Patient Over 26 Weeks: Treatment Comparisons (Without Imputation; Full Analysis Set)
three
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 12 and 26 weeksThe mean daily number of puffs of rescue medication taken by the patient will be derived. If the number of puffs is missing for part of the day (either morning or evening) then a half day will be used in the denominator. Rescue medication data recorded during the 14 day run-in period will be used to calculate the baseline. The mean change from baseline in the daily number of puffs of rescue medication will be analyzed using the same mixed model as specified for the primary analysis, with the baseline FEV1 replaced with the baseline daily rescue use.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment
Baseline
|
1.82 number of puffs
Standard Deviation 2.274
|
1.83 number of puffs
Standard Deviation 2.035
|
|
Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment
Week 12
|
1.50 number of puffs
Standard Deviation 1.883
|
1.45 number of puffs
Standard Deviation 1.697
|
|
Mean Daily Number of Puffs of Rescue Medication Used Over 26 Weeks of Treatment
Week 26
|
1.37 number of puffs
Standard Deviation 1.775
|
1.37 number of puffs
Standard Deviation 1.678
|
SECONDARY outcome
Timeframe: 26 weeksPopulation: Full Analysis Set
A 'day with no rescue use' is defined from diary data as any day where the patient has taken no puffs of rescue medication. The percentage of 'days with no rescue use' will be derived and analyzed as for the percentage of 'nights with no nighttime awakenings'.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Rescue Medication Use Over 26 Weeks: Percentage of 'Days With no Rescue Use'
|
52.8 % of Days
Standard Error 3.71
|
54.6 % of Days
Standard Error 3.68
|
SECONDARY outcome
Timeframe: 12 and 26 weeksPopulation: Full Analysis set
A Total and three component scores are calculated: Symptoms; Activity; Impacts. Each component of the questionnaire is scored separately:The score for each component is calculated separately by dividing the summed weights by the maximum possible weight for that component and expressing the result as a percentage: Score = 100 x Summed weights from all positive items in that component divided by Sum of weights for all items in that component The Total score is calculated in similar way: Score = 100 x Summed weights from all positive items in the questionnaire divided by Sum of weights for all items in the questionnaire Sum of maximum possible weights for each component and Total: Symptoms 566.2 Activity 982.9 Impacts 1652.8 Total (sum of maximum for all three components) 3201.9 The proportion of patients who achieve a clinically important improvement of at least 4 units in the total SGRQ will be analyzed. The higher the score the more symptoms of disease are present.
Outcome measures
| Measure |
Indacaterol
n=293 Participants
Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone Propionate
n=288 Participants
Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
St Georges Respiratory Questionnaire for COPD
Week 12
|
32.8 scores on a scale
Standard Error 1.58
|
32.9 scores on a scale
Standard Error 1.61
|
|
St Georges Respiratory Questionnaire for COPD
Week 26
|
33.1 scores on a scale
Standard Error 1.87
|
33.5 scores on a scale
Standard Error 1.93
|
Adverse Events
Indacaterol
Salmeterol/Fluticasone
Serious adverse events
| Measure |
Indacaterol
n=293 participants at risk
Indacaterol 150 μg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone
n=288 participants at risk
Salmeterol 50 μg /fluticasone propionate 500 μg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/293
|
0.35%
1/288
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/293
|
0.35%
1/288
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/293
|
0.69%
2/288
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/293
|
0.35%
1/288
|
|
Cardiac disorders
Cardiac failure
|
0.34%
1/293
|
0.00%
0/288
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/293
|
0.35%
1/288
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/293
|
0.35%
1/288
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/293
|
0.35%
1/288
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/293
|
0.35%
1/288
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.34%
1/293
|
0.00%
0/288
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/293
|
0.35%
1/288
|
|
General disorders
Sudden death
|
0.00%
0/293
|
0.35%
1/288
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/293
|
0.35%
1/288
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/293
|
0.35%
1/288
|
|
Infections and infestations
Pneumonia
|
0.00%
0/293
|
0.69%
2/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.34%
1/293
|
0.00%
0/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma
|
0.00%
0/293
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurilemmoma benign
|
0.00%
0/293
|
0.35%
1/288
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.00%
0/293
|
0.35%
1/288
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/293
|
0.35%
1/288
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.34%
1/293
|
1.0%
3/288
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.34%
1/293
|
0.00%
0/288
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/293
|
0.35%
1/288
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.00%
0/293
|
0.35%
1/288
|
Other adverse events
| Measure |
Indacaterol
n=293 participants at risk
Indacaterol 150 μg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
|
Salmeterol/Fluticasone
n=288 participants at risk
Salmeterol 50 μg /fluticasone propionate 500 μg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.1%
15/293
|
6.2%
18/288
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
20.5%
60/293
|
24.7%
71/288
|
Additional Information
Study Director
Novartis Pharmaceuticals
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 (ie, data from all sites) in the clinical trial
- Publication restrictions are in place
Restriction type: OTHER