Multicentre, randomised, double-blind, placebo-controlled, parallel-group comparison in order to prove efficacy and tolerability of cineole in the long-term treatment of patients with chronic obstructive pulmonary disease (COPD)
- Conditions
- Chronic obstructive pulmonary disease (COPD)RespiratoryOther chronic obstructive pulmonary disease
- Registration Number
- ISRCTN07600011
- Lead Sponsor
- MKL Institute of Clinical Research (MKL Institut für Klinische Forschung GmbH) (Germany)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 240
1. Patients (both males and females) with COPD, at least three exacerbations during the winter months
2. Forced expiratory volume in 1 second (FEV1) greater than 30% and less than 70% of predicted value, increase of FEV1 less than 15% and less than 200 ml after inhalation of beta-agonists
3. Smoker/ex-smoker greater than 10 pack years
1. Aged less than 40 years and greater than 80 years
2. Asthma bronchiale
3. Comedication with other mucolytics
4. Infection at the beginning of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method