A randomized, multi center, parallel group, double-blind, placebo and formoterol controlled 14 day dose ranging trial 4 doses of indacaterol delivered via Twisthaler®, in patients with COPD.
- Conditions
- -J449 Chronic obstructive pulmonary disease, unspecifiedChronic obstructive pulmonary disease, unspecifiedJ449
- Registration Number
- PER-078-07
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Male adults and women> 40 years of age who have signed the informed consent form before the start of any procedure related to the study (which includes any adjustment of their current treatment for COPD - see Section 6.6.5.5.)
• Cooperative outpatients diagnosed with COPD (moderate to severe according to the classification of the GOLD guidelines, 2006) and:
Smoking history of at least 10 packets-year
Post-bronchodilator VEF1 <80% and> 30% of the predictive normal value.
VEF1 / CVF Post-bronchodilator <70%
• Pregnant women, breastfeeding mothers or women with reproductive potential, regardless of whether they are sexually active or not, if they are not going to use acceptable methods of contraception.
• Patients who have been hospitalized for an exacerbation of their airway disease within 6 weeks prior to visit 1 or between visit 1 and 2.
• Patients with a history of asthma.
• Patients with acute respiratory tract infection within 4 weeks prior to visit 1, will not be able to enter the study.
• Other clinically significant conditions that may interfere with the conduct of the study or with patient safety, as specified in the protocol. (For a complete listing of the exclusion criteria refer to Section 5.1)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:hange in basal FEV1 valley 24 hours post-dose<br>Measure:Mean change in basal FEV1 valley 24 hours post-dose after 14 days of treatment<br>Timepoints:14 days<br>
- Secondary Outcome Measures
Name Time Method