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
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD
- Registration Number
- EUCTR2007-003189-16-LV
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 558
-Male and female adults aged =40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which include any adjustment to their current COPD treatment – see Section 6.6.5.5.)
-Cooperative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and:
a) Smoking history of at least 10 pack years
b) Post-bronchodilator FEV1 < 80% and =30% of the predicted normal value.
c) Post-bronchodilator FEV1/FVC < 70%
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
-Pregnant women, nursing mothers, or females of childbearing potential, regardless of whether or not sexually active, if they are not using acceptable methods of contraception.
-Patients who have been hospitalized for an exacerbation of their airways disease within 6 weeks prior to Visit 1 or between Visit 1 and Visit 2.
-Patients with a history of asthma.
-Patients with an acute respiratory tract infection within 4 weeks prior to Visit 1, will be not allowed to enter the study.
-Other clinically significant conditions which may interfere with the study conduct or patient safety
as specified in 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