At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of moderate-to-severe COPD per GOLD 2007 guidelines
- ✓Smoking history of at least 10 pack-years
- ✓Post-bronchodilator FEV1 between 30% and 65% of predicted normal value
- ✓Post-bronchodilator FEV1/FVC ratio less than 70%
- ✕COPD exacerbation requiring systemic glucocorticosteroids, antibiotics, and/or hospitalization within 6 weeks prior to screening or during run-in
- ✕Respiratory tract infection within 6 weeks prior to screening or during run-in
- ✕Body mass index less than 15 or greater than 40 kg/m²
- ✕Concomitant pulmonary disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating Indacaterol 150 μg, Tiotropium 18 μg, and 1 other intervention for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,134 participants across 137 sites in 12 countries.
Detailed Summary
This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)
Study Details
Timeline
Interventions
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.