At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, 3-period, 14-day Crossover Study to Determine the 24 Hour Lung Function Profile of Indacaterol (300 µg Once Daily [od]) in Patients With Moderate-to-severe COPD, Using Open-label Salmeterol (50 µg Twice Daily [Bis in Die, Bid]) as Active Control
In Brief
A Phase 3 clinical trial evaluating Indacaterol 300 μg, Placebo to indacaterol, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 68 participants across 14 sites in 3 countries.
Detailed Summary
This study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (FEV1) over a 24 hour time period.
Study Details
Timeline
Interventions
Indacaterol 300 μg was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).
Placebo to indacaterol was provided in powder filled capsules with a single-dose dry-powder inhaler (SDDPI).
Salmeterol 50 μg was provided in powder filled capsules with a multi-dose dry-powder inhaler (MDDPI).