Phase 3
N=552
Efficacy and Safety of Different Doses of Indacaterol in Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01089127 ↗Enrolled (actual)
552
Serious AEs
0.9%
Results posted
Aug 2011
Primary outcome: Primary: Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15) — 1.35; 1.38; 1.38; 1.40 Liters
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Indacaterol (Drug); Salmeterol 50 μg (Drug); Placebo to indacaterol (Drug); Placebo to salmeterol (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of the Study (Week 2 + 1 Day, Day 15) |
1.35; 1.38; 1.38; 1.40; 1.39; 1.28 | — |
| SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2 |
1.33; 1.34; 1.38; 1.40; 1.41; 1.28 | — |
Summary
This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.
Eligibility Criteria
Inclusion criteria
- Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2008) and:
- Smoking history of at least 10 pack-years
- Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
- Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%
Exclusion criteria
- Patients who have had a COPD exacerbation requiring systemic corticosteroids and/or antibiotics and/or hospitalization in the 6 weeks prior to screening
- 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
- Patients with a history of certain cardiovascular comorbid conditions
Other protocol-defined inclusion/exclusion criteria applied to the study.
Data sourced from ClinicalTrials.gov (NCT01089127). 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.