Trial Outcomes & Findings for Efficacy and Safety of Different Doses of Indacaterol (NCT NCT01079130)
NCT ID: NCT01079130
Last Updated: 2011-08-19
Results Overview
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
511 participants
Primary outcome timeframe
Day 15 (after 2 weeks of treatment)
Results posted on
2011-08-19
Participant Flow
The study consisted of a 14 day run-in period. 511 participants were randomized but only 502 participants received study drug.
Participant milestones
| Measure |
Indacaterol 18.75 µg
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
|
Indacaterol 37.5 µg
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 75 µg
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 150 µg
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Salmeterol
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Placebo
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
84
|
86
|
86
|
85
|
|
Overall Study
Safety Set: Received Study Drug
|
84
|
81
|
84
|
85
|
84
|
84
|
|
Overall Study
Full Analysis Set (FAS)
|
84
|
80
|
83
|
85
|
84
|
84
|
|
Overall Study
COMPLETED
|
83
|
78
|
83
|
81
|
78
|
80
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
1
|
5
|
8
|
5
|
Reasons for withdrawal
| Measure |
Indacaterol 18.75 µg
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
|
Indacaterol 37.5 µg
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 75 µg
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 150 µg
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Salmeterol
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Placebo
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
1
|
5
|
1
|
|
Overall Study
Administrative problems
|
1
|
3
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
1
|
3
|
|
Overall Study
Protocol deviation
|
0
|
2
|
1
|
2
|
0
|
0
|
|
Overall Study
Abnormal test procedure result(s)
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety of Different Doses of Indacaterol
Baseline characteristics by cohort
| Measure |
Indacaterol 18.75 µg
n=84 Participants
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
|
Indacaterol 37.5 µg
n=81 Participants
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 75 µg
n=84 Participants
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=85 Participants
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Salmeterol
n=84 Participants
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Placebo
n=84 Participants
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Total
n=502 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age Continuous
|
42.0 years
STANDARD_DEVIATION 14.64 • n=93 Participants
|
41.9 years
STANDARD_DEVIATION 14.96 • n=4 Participants
|
40.2 years
STANDARD_DEVIATION 14.71 • n=27 Participants
|
41.0 years
STANDARD_DEVIATION 15.20 • n=483 Participants
|
40.9 years
STANDARD_DEVIATION 14.56 • n=36 Participants
|
40.6 years
STANDARD_DEVIATION 14.17 • n=10 Participants
|
41.1 years
STANDARD_DEVIATION 14.65 • n=115 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
46 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
55 Participants
n=483 Participants
|
46 Participants
n=36 Participants
|
40 Participants
n=10 Participants
|
278 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
38 Participants
n=36 Participants
|
44 Participants
n=10 Participants
|
224 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 15 (after 2 weeks of treatment)Population: Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure. Missing data were imputed last observation carried forward (LOCF).
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Outcome measures
| Measure |
Indacaterol 18.75 µg
n=82 Participants
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
|
Indacaterol 37.5 µg
n=77 Participants
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 75 µg
n=82 Participants
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=80 Participants
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Salmeterol
n=78 Participants
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Placebo
n=81 Participants
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) After 2 Weeks of Treatment
|
2.50 Liters
Standard Error 0.036
|
2.52 Liters
Standard Error 0.037
|
2.59 Liters
Standard Error 0.036
|
2.54 Liters
Standard Error 0.037
|
2.54 Liters
Standard Error 0.037
|
2.42 Liters
Standard Error 0.036
|
SECONDARY outcome
Timeframe: Day 2 (after 1 day of treatment)Population: Participants from the Full Analysis Set, randomized participants who received at least one dose of study drug, who had efficacy data for this outcome measure.
Spirometry was conducted according to internationally accepted standards. The trough FEV1 was defined as the average of the FEV1 measurements taken at 23 hours 10 minutes and 23 hours 45 minutes post dose on day 2. The mixed model used baseline FEV1 and FEV1 prior to and 30 minutes post inhalation of albuterol as covariates.
Outcome measures
| Measure |
Indacaterol 18.75 µg
n=83 Participants
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
|
Indacaterol 37.5 µg
n=77 Participants
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 75 µg
n=81 Participants
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=82 Participants
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Salmeterol
n=79 Participants
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Placebo
n=80 Participants
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) After 1 Day of Treatment
|
2.46 Liters
Standard Error 0.026
|
2.52 Liters
Standard Error 0.027
|
2.54 Liters
Standard Error 0.026
|
2.60 Liters
Standard Error 0.026
|
2.65 Liters
Standard Error 0.027
|
2.45 Liters
Standard Error 0.027
|
Adverse Events
Indacaterol 18.75 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Indacaterol 37.5 µg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Indacaterol 75 µg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Indacaterol 150 µg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Salmeterol
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 18.75 µg
n=84 participants at risk
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
|
Indacaterol 37.5 µg
n=81 participants at risk
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 75 µg
n=84 participants at risk
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=85 participants at risk
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Salmeterol
n=84 participants at risk
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Placebo
n=84 participants at risk
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|---|---|
|
Psychiatric disorders
Substance abuse
|
0.00%
0/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
0.00%
0/81 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
0.00%
0/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
1.2%
1/85 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
0.00%
0/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
0.00%
0/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Indacaterol 18.75 µg
n=84 participants at risk
Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
|
Indacaterol 37.5 µg
n=81 participants at risk
Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 75 µg
n=84 participants at risk
Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Indacaterol 150 µg
n=85 participants at risk
Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Salmeterol
n=84 participants at risk
Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
Placebo
n=84 participants at risk
Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
2.4%
2/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
2.5%
2/81 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
6.0%
5/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
3.5%
3/85 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
4.8%
4/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
4.8%
4/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
2/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
0.00%
0/81 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
9.5%
8/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
4.7%
4/85 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
1.2%
1/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
0.00%
0/84 • 2 weeks
Safety Population consisting of all participants who received at least one dose of study drug.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
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