Trial Outcomes & Findings for 12-week Efficacy of Indacaterol (NCT NCT01072448)
NCT ID: NCT01072448
Last Updated: 2011-08-19
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 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
323 participants
Primary outcome timeframe
24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
Results posted on
2011-08-19
Participant Flow
Participant milestones
| Measure |
Indacaterol 75 μg
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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 to Indacaterol
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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.
|
|---|---|---|
|
Overall Study
STARTED
|
163
|
160
|
|
Overall Study
COMPLETED
|
144
|
130
|
|
Overall Study
NOT COMPLETED
|
19
|
30
|
Reasons for withdrawal
| Measure |
Indacaterol 75 μg
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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 to Indacaterol
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
9
|
10
|
|
Overall Study
Subject withdrew consent
|
4
|
9
|
|
Overall Study
Protocol deviation
|
3
|
4
|
|
Overall Study
Abnormal test procedure result(s)
|
1
|
0
|
|
Overall Study
Unsatisfactory therapeutic effect
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Abnormal laboratory value(s)
|
0
|
1
|
|
Overall Study
Death
|
0
|
2
|
Baseline Characteristics
12-week Efficacy of Indacaterol
Baseline characteristics by cohort
| Measure |
Indacaterol 75 μg
n=163 Participants
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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 to Indacaterol
n=160 Participants
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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.
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
64.0 years
STANDARD_DEVIATION 8.29 • n=5 Participants
|
64.1 years
STANDARD_DEVIATION 9.43 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 8.86 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)Population: Full analysis set: All randomized patients who received at least 1 dose of study drug, 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 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 75 μg
n=149 Participants
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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 to Indacaterol
n=148 Participants
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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.
|
|---|---|---|
|
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 12 + 1 Day, Day 85)
|
1.38 Liters
Standard Error 0.013
|
1.26 Liters
Standard Error 0.013
|
SECONDARY outcome
Timeframe: End of the study (Week 12, Day 84)Population: Full analysis set: All randomized patients who received at least 1 dose of study drug, last observation carried forward (LOCF).
An independent (where feasible), trained assessor interviewed the patient and rated the degree of impairment due to dyspnea on a scale from -3 (major deterioration) to 3 (major improvement) on 3 domains (functional impairment, magnitude of task, and magnitude of effort) in comparison with baseline. A total score of the 3 domains ranged from -9 to 9; minus scores indicate deterioration. The analysis included baseline dyspnea index, FEV1 pre-dose and 10-15 minutes post-dose of albuterol during screening, and FEV1 pre-dose and 50-70 minutes post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 75 μg
n=150 Participants
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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 to Indacaterol
n=150 Participants
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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.
|
|---|---|---|
|
Transition Dyspnea Index (TDI) Total Score at the End of the Study (Week 12, Day 84)
|
1.34 Units on a scale
Standard Error 0.284
|
0.11 Units on a scale
Standard Error 0.287
|
Adverse Events
Indacaterol 75 μg
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Placebo to Indacaterol
Serious events: 9 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 75 μg
n=163 participants at risk
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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 to Indacaterol
n=160 participants at risk
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.61%
1/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.00%
0/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.62%
1/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.62%
1/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.61%
1/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.00%
0/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
1.2%
2/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.62%
1/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.62%
1/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.62%
1/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mycosis fungoides
|
0.61%
1/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.00%
0/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.61%
1/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
2.5%
4/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.62%
1/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
0.62%
1/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
Other adverse events
| Measure |
Indacaterol 75 μg
n=163 participants at risk
Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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 to Indacaterol
n=160 participants at risk
Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 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
Urinary tract infection
|
5.5%
9/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
1.2%
2/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
5.5%
9/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
3.8%
6/160 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
8.6%
14/163 • 12 weeks
The safety set, included all patients who received at least one dose of study drug.
|
9.4%
15/160 • 12 weeks
The safety set, 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