Phase 3
Completed N=1,732
Efficacy, Safety, and Tolerability of Once Daily Indacaterol in Chronic Obstructive Pulmonary Disease (COPD) Using Formoterol Twice Daily as Active Control
Source: ClinicalTrials.gov NCT00393458 ↗Enrolled (actual)
1,732
Serious AEs
13.4%
Results posted
Aug 2011
Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 — 1.48; 1.48; 1.38; 1.31 Liters
Summary
This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 + 1 Day, Day 85 |
1.48; 1.48; 1.38; 1.31 | — |
| SECONDARY Percentage of Days of Poor Control During 52 Weeks of Treatment |
33.6; 30.0; 33.5; 38.3 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (COPD) according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines 2005 and:
- Smoking history of at least 20 pack years
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced volume capacity) < 70% (Post refers to within 30 minutes after inhalation of 400 μg of salbutamol)
Exclusion Criteria
- Patients who were hospitalized for a COPD exacerbation in the 6 weeks prior to screening.
- Patients who had a respiratory tract infection within 6 weeks prior to screening.
- Patients with concomitant pulmonary disease.
- Patients with a history of asthma.
- Patients with diabetes type I or uncontrolled diabetes type II.
- Any patient with lung cancer or a history of lung cancer.
- Patients with a history of certain cardiovascular co-morbid conditions.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00393458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.