NL-OMON32333CompletedPhase 3
A phase III, randomized, double-blind, double-dummy, placebo-controlled, multicenter, 3-period incomplete block, multidose crossover study to determine the effect on lung function of indacaterol (150 and 300 mcg o.d.) in patients with moderate to severe COPD, using tiotropium (18 mcg o.d.) as an active control - CQAB149B2331
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- ovartis
- Enrollment
- 26
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •* Male or female patients aged 40 years and older
- •* Patients with moderate to severe stable COPD according to the COLD Guidelines 2006
- •* Patients with a smoking history of at least 10 pack years
- •* Patients with a post-brochodilator FEV1 equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post bronchodilator FEV1/FVC less than 0.7
Exclusion Criteria
- •* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
- •* Patients requiring long term oxygen therapy
- •* Patients who have had a respiratory tact infection within 6 weeks prior to V1
- •* Patients with a history of Asthma
- •* Patients with diabetes Type 1 and uncontrolled diabetes type II
- •* Patients with a hostory of long QT syndrome or whose QTc interval measured at visti 1 or 3 is prolonged
Investigators
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