Trial Outcomes & Findings for Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00794157)
NCT ID: NCT00794157
Last Updated: 2011-08-17
Results Overview
FEV1 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 the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
347 participants
Primary outcome timeframe
End of treatment (Week 12 + 1 day, Day 85)
Results posted on
2011-08-17
Participant Flow
Participant milestones
| Measure |
Indacaterol 150 μg
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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
|
114
|
116
|
117
|
|
Overall Study
COMPLETED
|
104
|
106
|
98
|
|
Overall Study
NOT COMPLETED
|
10
|
10
|
19
|
Reasons for withdrawal
| Measure |
Indacaterol 150 μg
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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
|
4
|
1
|
8
|
|
Overall Study
Subject withdrew consent
|
2
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
1
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
0
|
2
|
|
Overall Study
Administrative problems
|
1
|
7
|
4
|
|
Overall Study
Abnormal test procedure result(s)
|
0
|
1
|
0
|
|
Overall Study
Protocol deviation
|
0
|
1
|
1
|
Baseline Characteristics
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Indacaterol 150 μg
n=114 Participants
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
n=116 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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=117 Participants
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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=347 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=93 Participants
|
113 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
335 Participants
n=483 Participants
|
|
Age Continuous
|
66.4 years
STANDARD_DEVIATION 8.75 • n=93 Participants
|
67.1 years
STANDARD_DEVIATION 7.67 • n=4 Participants
|
66.5 years
STANDARD_DEVIATION 8.74 • n=27 Participants
|
66.7 years
STANDARD_DEVIATION 8.38 • n=483 Participants
|
PRIMARY outcome
Timeframe: End of treatment (Week 12 + 1 day, Day 85)Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug. The imputation technique used as last observation carried forward (LOCF).
FEV1 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 the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg
n=109 Participants
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
n=110 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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=104 Participants
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 the End of Treatment (Week 12 + 1 Day, Day 85)
|
1.34 Liters
Standard Error 0.024
|
1.37 Liters
Standard Error 0.023
|
1.17 Liters
Standard Error 0.025
|
SECONDARY outcome
Timeframe: After Week 2 (Day 15)Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.
FEV1 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 2. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg
n=93 Participants
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
n=85 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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=82 Participants
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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) at Week 2
|
1.33 Liters
Standard Error 0.023
|
1.34 Liters
Standard Error 0.023
|
1.17 Liters
Standard Error 0.024
|
SECONDARY outcome
Timeframe: After Week 4 (Day 29)Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.
FEV1 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 4. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg
n=81 Participants
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
n=82 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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=80 Participants
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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) at Week 4
|
1.32 Liters
Standard Error 0.024
|
1.33 Liters
Standard Error 0.022
|
1.18 Liters
Standard Error 0.024
|
SECONDARY outcome
Timeframe: After Week 8 (Day 57)Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.
FEV1 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 8. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg
n=81 Participants
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
n=79 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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=71 Participants
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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) at Week 8
|
1.30 Liters
Standard Error 0.029
|
1.32 Liters
Standard Error 0.027
|
1.14 Liters
Standard Error 0.030
|
SECONDARY outcome
Timeframe: Prior to last dose at Week 12 (Day 84)Population: Intent-to-treat (ITT) population: All randomized patients who received at least 1 dose of study drug.
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 50 and 15 minutes pre-dose at the end of treatment. The analysis included baseline FEV1, FEV1 pre-dose and 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 60 minutes post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg
n=81 Participants
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
n=79 Participants
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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=70 Participants
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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) at Week 12 (Day 84)
|
1.34 Liters
Standard Error 0.032
|
1.34 Liters
Standard Error 0.030
|
1.13 Liters
Standard Error 0.031
|
Adverse Events
Indacaterol 150 μg
Serious events: 4 serious events
Other events: 24 other events
Deaths: 0 deaths
Indacaterol 300 μg
Serious events: 2 serious events
Other events: 26 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 150 μg
n=114 participants at risk
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
n=116 participants at risk
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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=117 participants at risk
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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
Thrombocytopenia
|
0.00%
0/114 • 12 weeks
Safety population.
|
0.86%
1/116 • 12 weeks
Safety population.
|
0.00%
0/117 • 12 weeks
Safety population.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/114 • 12 weeks
Safety population.
|
0.00%
0/116 • 12 weeks
Safety population.
|
0.85%
1/117 • 12 weeks
Safety population.
|
|
Cardiac disorders
Cor pulmonale
|
0.00%
0/114 • 12 weeks
Safety population.
|
0.00%
0/116 • 12 weeks
Safety population.
|
0.85%
1/117 • 12 weeks
Safety population.
|
|
Eye disorders
Cataract
|
0.00%
0/114 • 12 weeks
Safety population.
|
0.00%
0/116 • 12 weeks
Safety population.
|
0.85%
1/117 • 12 weeks
Safety population.
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/114 • 12 weeks
Safety population.
|
0.00%
0/116 • 12 weeks
Safety population.
|
0.85%
1/117 • 12 weeks
Safety population.
|
|
General disorders
Concomitant disease progression
|
0.00%
0/114 • 12 weeks
Safety population.
|
0.00%
0/116 • 12 weeks
Safety population.
|
0.85%
1/117 • 12 weeks
Safety population.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/114 • 12 weeks
Safety population.
|
0.86%
1/116 • 12 weeks
Safety population.
|
0.00%
0/117 • 12 weeks
Safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.88%
1/114 • 12 weeks
Safety population.
|
0.00%
0/116 • 12 weeks
Safety population.
|
0.00%
0/117 • 12 weeks
Safety population.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.88%
1/114 • 12 weeks
Safety population.
|
0.00%
0/116 • 12 weeks
Safety population.
|
0.00%
0/117 • 12 weeks
Safety population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.88%
1/114 • 12 weeks
Safety population.
|
0.00%
0/116 • 12 weeks
Safety population.
|
0.00%
0/117 • 12 weeks
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
2/114 • 12 weeks
Safety population.
|
1.7%
2/116 • 12 weeks
Safety population.
|
1.7%
2/117 • 12 weeks
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/114 • 12 weeks
Safety population.
|
0.00%
0/116 • 12 weeks
Safety population.
|
0.85%
1/117 • 12 weeks
Safety population.
|
Other adverse events
| Measure |
Indacaterol 150 μg
n=114 participants at risk
Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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 300 μg
n=116 participants at risk
Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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=117 participants at risk
Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). 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
|
8.8%
10/114 • 12 weeks
Safety population.
|
6.9%
8/116 • 12 weeks
Safety population.
|
9.4%
11/117 • 12 weeks
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
8.8%
10/114 • 12 weeks
Safety population.
|
7.8%
9/116 • 12 weeks
Safety population.
|
12.0%
14/117 • 12 weeks
Safety population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.4%
5/114 • 12 weeks
Safety population.
|
9.5%
11/116 • 12 weeks
Safety population.
|
2.6%
3/117 • 12 weeks
Safety population.
|
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