Phase 3
Completed N=347
Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT00794157 ↗Enrolled (actual)
347
Serious AEs
3.5%
Results posted
Aug 2011
Primary outcomePrimary: 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; 1.37; 1.17 Liters
Summary
This study was designed to provide pivotal confirmation of efficacy and safety data for 2 doses of indacaterol (150 and 300 µg once daily [od]) in patients with moderate to severe chronic obstructive pulmonary disease (COPD). Data from this study will be used for the registration of indacaterol in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; 1.37; 1.17 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 2 |
1.33; 1.34; 1.17 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 |
1.32; 1.33; 1.18 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 8 |
1.30; 1.32; 1.14 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12 (Day 84) |
1.34; 1.34; 1.13 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of moderate-to-severe chronic obstructive pulmonary disease (COPD), as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines and:
- Smoking history of at least 20 pack-years.
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) 15 hours a day) for chronic hypoxemia.
- Patients who have 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.
- Any patient with active cancer or a history of cancer with less than 5 years disease-free survival time.
- Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at screening or randomization is prolonged.
- Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
- Patients unable to successfully use a dry powder inhaler device or perform spirometry measurements.
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT00794157). 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.