At a glance
ClinicalIndex Comparison Record- ✓Japanese patients aged 40 to 75 years
- ✓Moderate to severe COPD
- ✓Smoking history of at least 20 pack years
- ✕Hospitalization for COPD exacerbation within past 6 months
- ✕Use of long-term oxygen therapy
- ✕History of asthma
- ✕Respiratory tract infection within past 1 month
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, 4-period 4-treatment Crossover, Multicenter, Dose-ranging Study to Assess the Efficacy and Safety of 3 Doses of Indacaterol (150, 300, and 600 µg) Delivered Via a Single Dose Dry Powder Inhaler in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 2 clinical trial evaluating Indacaterol 150 μg, Indacaterol 300 μg, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 50 participants across 8 sites.
Detailed Summary
The study was designed to obtain data about the efficacy and safety of 3 doses of indacaterol (150, 300, and 600 µg) in Japanese patients with chronic obstructive pulmonary disease (COPD) so that optimal dose(s) could be chosen for testing in later studies.
Study Details
Timeline
Interventions
Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).
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).