A randomized, multi-center, parallel group, double blind, placebo and formoterol controlled 14 day dose ranging trial of 4 doses of indacaterol delivered via Twisthaler in patients with COPD - ND
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10009026Term: Chronic obstructive airways disease
- Registration Number
- EUCTR2007-003189-16-IT
- Lead Sponsor
- OVARTIS FARMA
- 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.) 2. 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% (Post refers to within 30 min of inhalation of 400/360 µg of salbutamol/albuterol MDI (or equivalent dose of DPI
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