Trial Outcomes & Findings for Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT00624286)
NCT ID: NCT00624286
Last Updated: 2011-08-18
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 1 hour post-dose of ipratropium during screening as covariates.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
416 participants
Primary outcome timeframe
24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)
Results posted on
2011-08-18
Participant Flow
Participant milestones
| Measure |
Indacaterol 150 μg
Patients inhaled indacaterol 150 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
|
211
|
205
|
|
Overall Study
COMPLETED
|
186
|
178
|
|
Overall Study
NOT COMPLETED
|
25
|
27
|
Reasons for withdrawal
| Measure |
Indacaterol 150 μg
Patients inhaled indacaterol 150 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
Protocol Deviation
|
7
|
9
|
|
Overall Study
Adverse Event
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Administrative problems
|
3
|
0
|
|
Overall Study
Lack of Efficacy
|
1
|
6
|
|
Overall Study
Not stated
|
0
|
1
|
|
Overall Study
Abnormal test procedure result(s)
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Indacaterol 150 μg
n=211 Participants
Patients inhaled indacaterol 150 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=205 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=416 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
62.9 years
STANDARD_DEVIATION 9.89 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 9.62 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours post-dose at the end of the study (Week 12 + 1 day, Day 85)Population: Intent-to-treat population: 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 30 minutes post-dose of salbutamol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg
n=201 Participants
Patients inhaled indacaterol 150 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=189 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)
|
1.48 Liters
Standard Error 0.018
|
1.35 Liters
Standard Error 0.019
|
SECONDARY outcome
Timeframe: 24 hours post-dose on Day 2Population: Intent-to-treat population: All randomized patients who received at least 1 dose of study drug. FEV1 data taken within 6 h of rescue medication was excluded from this analysis.
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 1 hour post-dose of ipratropium during screening as covariates.
Outcome measures
| Measure |
Indacaterol 150 μg
n=205 Participants
Patients inhaled indacaterol 150 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=197 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 on Day 2
|
1.47 Liters
Standard Error 0.014
|
1.38 Liters
Standard Error 0.014
|
Adverse Events
Indacaterol 150 μg
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo to Indacaterol
Serious events: 5 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Indacaterol 150 μg
n=211 participants at risk
Patients inhaled indacaterol 150 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=205 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.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.47%
1/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.00%
0/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.49%
1/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.47%
1/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.00%
0/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.47%
1/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.00%
0/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
General disorders
Death
|
0.00%
0/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.49%
1/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.47%
1/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.00%
0/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal infection
|
0.47%
1/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.00%
0/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Exposure to toxic agent
|
0.47%
1/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.00%
0/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.49%
1/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.47%
1/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.00%
0/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.98%
2/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
0.47%
1/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.00%
0/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.47%
1/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
0.00%
0/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
Other adverse events
| Measure |
Indacaterol 150 μg
n=211 participants at risk
Patients inhaled indacaterol 150 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=205 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.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
8.5%
18/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
11.7%
24/205 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
13/211 • 12 weeks
Safety population included all patients who received at least one dose of study drug.
|
7.3%
15/205 • 12 weeks
Safety population 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