A 26-week treatment, multicenter, randomized, double-blind, double dummy, placebo-controlled, adaptive, seamless, parallel-group study to assess the efficacy, safety and tolerability of indacaterol (75, 150, 300 & 600 µg o.d.) in patients with chronic obstructive pulmonary disease using formoterol (12 µg b.i.d) and open label tiotropium (18 µg o.d.) as active controls
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)
- Registration Number
- EUCTR2006-001955-37-SE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1945
1.Male and female adults aged = 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
2.Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2005) and:
a)Smoking history of at least 20 pack years
b)Post-bronchodilator FEV1 < 80% and =30% of the predicted normal value.
c Post-bronchodilator FEV1/FVC < 70%
(Post refers to within 30 min of inhalation of 400 µg of salbutamol)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Please see the Protocol
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method