Trial Outcomes & Findings for The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (NCT NCT00620022)
NCT ID: NCT00620022
Last Updated: 2011-08-17
Results Overview
At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
End of each 3 week treatment period (last day of Weeks 3 and 9)
Results posted on
2011-08-17
Participant Flow
Participant milestones
| Measure |
Indacaterol 300 μg Followed by Placebo
Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. 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.
|
Placebo Followed by Indacaterol 300 μg
Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. 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.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
46
|
43
|
|
Treatment Period 1
COMPLETED
|
41
|
37
|
|
Treatment Period 1
NOT COMPLETED
|
5
|
6
|
|
Treatment Period 2
STARTED
|
41
|
37
|
|
Treatment Period 2
COMPLETED
|
39
|
35
|
|
Treatment Period 2
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Indacaterol 300 μg Followed by Placebo
Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. 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.
|
Placebo Followed by Indacaterol 300 μg
Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. 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.
|
|---|---|---|
|
Treatment Period 1
Adverse Event
|
4
|
6
|
|
Treatment Period 1
Subject withdrew consent
|
1
|
0
|
|
Treatment Period 2
Adverse Event
|
2
|
2
|
Baseline Characteristics
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=89 Participants
The entire study population includes the group of patients who received indacaterol 300 μg in the first treatment period followed by placebo in the second treatment period and the group of patients who received placebo in the first treatment period followed by indacaterol 300 μg in the second treatment period. 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.
|
|---|---|
|
Age Continuous
|
62.8 years
STANDARD_DEVIATION 8.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of each 3 week treatment period (last day of Weeks 3 and 9)Population: Modified intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.
At the end of each 3 week treatment period, patients completed constant-load cycle ergometry testing at a work-rate of 75% of the Wmax determined at Screening. This work-rate was maintained until symptom limitation caused the patient to stop exercising. The time from the start of loaded pedaling until the patient stopped exercising was recorded.
Outcome measures
| Measure |
Indacaterol 300 μg
n=78 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
|
Placebo
n=73 Participants
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
|
|---|---|---|
|
Exercise Duration Time Assessed by Constant-load Cycle Ergometry at the End of Each Treatment Period
|
586 Seconds
Standard Error 30.3
|
475 Seconds
Standard Error 31.3
|
SECONDARY outcome
Timeframe: End of each 3 week treatment period (last day of Weeks 3 and 9)Population: Modified-intent-to-treat (modified ITT) population: All randomized patients who received at least 1 dose of study drug. The number of patients analyzed for each treatment group was the number with non-missing values for the dependent and independent variables in the mixed model.
At the end of each 3 week treatment period 60 minutes before inhalation of study drug, IC was measured with spirometry conducted according to internationally accepted standards. The mean of 3 acceptable measurements was calculated and reported in liters.
Outcome measures
| Measure |
Indacaterol 300 μg
n=78 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
|
Placebo
n=77 Participants
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
|
|---|---|---|
|
Inspiratory Capacity (IC) Assessed at Rest With Spirometry at the End of Each Treatment Period 60 Minutes Pre-dose
|
2.39 Liters
Standard Error 0.034
|
2.25 Liters
Standard Error 0.034
|
Adverse Events
Indacaterol 300 μg
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 300 μg
n=83 participants at risk
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
|
Placebo
n=84 participants at risk
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/83 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
1.2%
1/84 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
1/83 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
0.00%
0/84 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
1.2%
1/83 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
0.00%
0/84 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
1.2%
1/83 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
0.00%
0/84 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/83 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
0.00%
0/84 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
Other adverse events
| Measure |
Indacaterol 300 μg
n=83 participants at risk
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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.
|
Placebo
n=84 participants at risk
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. 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
Nasopharyngitis
|
7.2%
6/83 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
7.1%
6/84 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.2%
1/83 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included all patients who received at least one dose of study drug.
|
6.0%
5/84 • Baseline to the end of the study (Week 9)
Adverse events are reported for the safety population which included 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