Trial Outcomes & Findings for Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma (NCT NCT00529529)
NCT ID: NCT00529529
Last Updated: 2011-08-29
Results Overview
Adverse events include asthma exacerbations. An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. Asthma worsening that required treatment with inhaled or nebulized short-acting β2-agonists or an increase in inhaled corticosteroids only was not considered an asthma exacerbation.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
805 participants
Primary outcome timeframe
Baseline (Day 1) to end of study (Week 26)
Results posted on
2011-08-29
Participant Flow
Participant milestones
| Measure |
Indacaterol 300 μg
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
268
|
268
|
269
|
|
Overall Study
COMPLETED
|
225
|
225
|
238
|
|
Overall Study
NOT COMPLETED
|
43
|
43
|
31
|
Reasons for withdrawal
| Measure |
Indacaterol 300 μg
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
12
|
17
|
8
|
|
Overall Study
Subject withdrew consent
|
12
|
9
|
12
|
|
Overall Study
Protocol deviation
|
8
|
12
|
5
|
|
Overall Study
Lost to Follow-up
|
5
|
3
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
2
|
2
|
2
|
|
Overall Study
Death
|
2
|
0
|
0
|
|
Overall Study
Abnormal test procedure result(s)
|
1
|
0
|
0
|
|
Overall Study
Administrative problems
|
1
|
0
|
3
|
Baseline Characteristics
Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma
Baseline characteristics by cohort
| Measure |
Indacaterol 300 μg
n=268 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=268 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=269 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Total
n=805 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
43.5 years
STANDARD_DEVIATION 15.84 • n=5 Participants
|
44.5 years
STANDARD_DEVIATION 15.19 • n=7 Participants
|
42.5 years
STANDARD_DEVIATION 15.24 • n=5 Participants
|
43.5 years
STANDARD_DEVIATION 15.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
490 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
315 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to end of study (Week 26)Population: Safety population: All patients who received at least one dose of study drug.
Adverse events include asthma exacerbations. An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. Asthma worsening that required treatment with inhaled or nebulized short-acting β2-agonists or an increase in inhaled corticosteroids only was not considered an asthma exacerbation.
Outcome measures
| Measure |
Indacaterol 300 μg
n=268 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=268 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=269 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Percentage of Patients With at Least 1 Adverse Event During the 26 Weeks of the Study
|
54.9 Percentage of patients
|
66.4 Percentage of patients
|
67.3 Percentage of patients
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.
Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and forced expiratory volume in 1 second (FEV1) pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=263 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=264 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=264 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Systolic Blood Pressure 1 Hour Post-dose at Day 1
|
122.79 mmHg
Standard Error 0.605
|
122.60 mmHg
Standard Error 0.605
|
122.56 mmHg
Standard Error 0.606
|
PRIMARY outcome
Timeframe: Week 12Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.
Systolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. The analysis included baseline systolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=238 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=237 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=244 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Systolic Blood Pressure 1 Hour Post-dose at Week 12
|
120.29 mmHg
Standard Error 0.802
|
121.98 mmHg
Standard Error 0.809
|
122.02 mmHg
Standard Error 0.801
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in this analysis.
Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=263 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=264 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=264 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Diastolic Blood Pressure 1 Hour Post-dose at Day 1
|
76.67 mmHg
Standard Error 0.484
|
76.55 mmHg
Standard Error 0.484
|
77.08 mmHg
Standard Error 0.485
|
PRIMARY outcome
Timeframe: Week 12Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.
Diastolic blood pressure measurements (in millimeters of mercury, mmHg) were made 1 hour post-dose after the patient had rested in the sitting position for at least 10 minutes. Measurements were made using an inflatable cuff around the upper arm. Phase V Korotkoff sounds were used for determination of diastolic pressure. The analysis included baseline diastolic blood pressure and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=238 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=237 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=244 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Diastolic Blood Pressure 1 Hour Post-dose at Week 12
|
75.38 mmHg
Standard Error 0.576
|
76.11 mmHg
Standard Error 0.580
|
76.96 mmHg
Standard Error 0.575
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.
The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR\^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=265 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=265 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=265 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Day 1
|
404.46 ms
Standard Error 0.706
|
404.97 ms
Standard Error 0.704
|
405.05 ms
Standard Error 0.706
|
PRIMARY outcome
Timeframe: Week 12Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.
The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR\^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=238 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=236 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=242 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 12
|
404.93 ms
Standard Error 0.970
|
407.78 ms
Standard Error 0.979
|
406.98 ms
Standard Error 0.967
|
PRIMARY outcome
Timeframe: Week 21Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at week 21 were included in the analysis.
The QTc interval (in milliseconds, ms) is calculated from electrocardiogram (ECG) data collected 1 hour post-dose using Fridericia's formula: QTc = QT/RR\^0.33. QTc is the interval between the Q and T waves corrected for heart rate and RR is the interval between two R waves. ECGs included all 12 standard leads and a Lead II rhythm strip of at least 10-second duration. All results were sent to a central laboratory for review by a cardiologist. The analysis included baseline QTc interval and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=227 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=228 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=237 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Corrected QT (QTc) Interval Using Fridericia's Formula Measured 1 Hour Post-dose at Week 21
|
406.41 ms
Standard Error 1.005
|
407.49 ms
Standard Error 1.014
|
407.23 ms
Standard Error 0.995
|
PRIMARY outcome
Timeframe: Week 12Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.
Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=74 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=75 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=69 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 12
|
81.0 bpm
Standard Error 1.10
|
81.7 bpm
Standard Error 1.11
|
80.4 bpm
Standard Error 1.05
|
PRIMARY outcome
Timeframe: Week 26Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at week 26 were included in the analysis.
Continuous 24 hour electrocardiography (Holter monitoring) was conducted in a subset of patients at designated study centers, and was used to calculate the mean heart rate (in beats per minute, bpm). Patients returned the Holter monitor recorder to the clinic the morning after the 24 hour recording was complete. The results of Holter monitoring were processed centrally. The analysis included baseline 24 hour mean heart rate and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=64 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=65 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=63 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
24 Hour Mean Heart Rate Determined From ECG Holter Monitoring at Week 26
|
79.4 bpm
Standard Error 0.96
|
81.0 bpm
Standard Error 0.96
|
79.2 bpm
Standard Error 0.96
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.
Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=266 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=262 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=257 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Serum Potassium 1 Hour Post-dose at Day 1
|
4.30 mmol/L
Standard Error 0.022
|
4.24 mmol/L
Standard Error 0.023
|
4.32 mmol/L
Standard Error 0.023
|
PRIMARY outcome
Timeframe: Week 12Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.
Serum potassium (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline serum potassium and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=235 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=233 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=241 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Serum Potassium 1 Hour Post-dose at Week 12
|
4.31 mmol/L
Standard Error 0.025
|
4.29 mmol/L
Standard Error 0.025
|
4.33 mmol/L
Standard Error 0.025
|
PRIMARY outcome
Timeframe: Day 1Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at Day 1 were included in the analysis.
Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=266 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=265 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=258 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Blood Glucose 1 Hour Post-dose at Day 1
|
5.24 mmol/L
Standard Error 0.061
|
5.45 mmol/L
Standard Error 0.061
|
5.21 mmol/L
Standard Error 0.062
|
PRIMARY outcome
Timeframe: Week 12Population: Safety population: All patients who received at least one dose of study drug. Participants with observations at week 12 were included in the analysis.
Blood glucose (in millimoles per liter, mmol/L) was measured from venous blood samples. Samples were sent to a central laboratory for analysis. The analysis included baseline blood glucose and FEV1 pre-dose and 30 minutes post-dose of salbutamol/albuterol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=235 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=234 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=241 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Blood Glucose 1 Hour Post-dose at Week 12
|
5.27 mmol/L
Standard Error 0.068
|
5.38 mmol/L
Standard Error 0.069
|
5.23 mmol/L
Standard Error 0.068
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to end of study (Week 26)Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.
A clinically significant asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with systemic corticosteroids. This includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with "asthma" as a key word in the preferred term.
Outcome measures
| Measure |
Indacaterol 300 μg
n=268 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=268 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=269 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study
0 exacerbations
|
92.9 Percentage of patients
|
89.9 Percentage of patients
|
90.0 Percentage of patients
|
|
Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study
1 exacerbation
|
5.6 Percentage of patients
|
9.3 Percentage of patients
|
8.6 Percentage of patients
|
|
Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study
2 exacerbations
|
0.7 Percentage of patients
|
0.7 Percentage of patients
|
1.5 Percentage of patients
|
|
Percentage of Patients With Clinically Significant Asthma Exacerbations During the 26 Weeks of the Study
3 exacerbations
|
0.7 Percentage of patients
|
0.0 Percentage of patients
|
0.0 Percentage of patients
|
SECONDARY outcome
Timeframe: 24 hours post-dose at Week 12 + 1 day, Day 85Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. Participants with observations at Day 85 were included in the analysis.
FEV1 (in liters, L) was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose at Week 12, Day 85. The analysis included baseline FEV1 and FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening as covariates.
Outcome measures
| Measure |
Indacaterol 300 μg
n=258 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=255 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=262 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at Week 12 + 1 Day, Day 85
|
2.61 Liters
Standard Error 0.023
|
2.62 Liters
Standard Error 0.023
|
2.54 Liters
Standard Error 0.023
|
SECONDARY outcome
Timeframe: Baseline (Day 1) to end of study (Week 26)Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.
An asthma exacerbation was defined as a worsening of asthma as judged clinically significant by the physician, requiring treatment with rescue oral or intravenous (IV) corticosteroids. The number of asthma exacerbations includes events recorded on the asthma exacerbation clinical report form (CRF) page and events recorded on the adverse events CRF page with "asthma" as a key word in the preferred term.
Outcome measures
| Measure |
Indacaterol 300 μg
n=268 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=268 Participants
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=269 Participants
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Number of Asthma Exacerbations Per Patient (Without Imputation) During the 26 Weeks of the Study
|
0.17 Asthma exacerbations
Standard Deviation 0.561
|
0.19 Asthma exacerbations
Standard Deviation 0.512
|
0.19 Asthma exacerbations
Standard Deviation 0.494
|
Adverse Events
Indacaterol 300 μg
Serious events: 5 serious events
Other events: 86 other events
Deaths: 0 deaths
Indacaterol 600 μg
Serious events: 11 serious events
Other events: 105 other events
Deaths: 0 deaths
Salmeterol 50 μg
Serious events: 8 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 300 μg
n=268 participants at risk
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=268 participants at risk
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=269 participants at risk
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Splenic cyst
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
General disorders
Sudden death
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Immune system disorders
Food allergy
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Infections and infestations
Abscess neck
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.75%
2/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Nervous system disorders
Facial paresis
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.75%
2/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Psychiatric disorders
Stress
|
0.37%
1/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Analgesic asthma syndrome
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.75%
2/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
1.1%
3/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.00%
0/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
0.37%
1/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
Other adverse events
| Measure |
Indacaterol 300 μg
n=268 participants at risk
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Indacaterol 600 μg
n=268 participants at risk
Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
Salmeterol 50 μg
n=269 participants at risk
Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
3.7%
10/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
4.9%
13/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
5.9%
16/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
7.5%
20/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
8.2%
22/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
9.7%
26/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.3%
17/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
10.1%
27/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
6.7%
18/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
5.2%
14/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
6.7%
18/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
7.4%
20/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.2%
30/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
14.6%
39/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
14.9%
40/269 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.4%
28/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
10.8%
29/268 • Baseline to the end of the study (Week 26)
Safety population: All patients who received at least one dose of study drug.
|
5.2%
14/269 • Baseline to the end of the study (Week 26)
Safety population: All patients 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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER