Trials / Completed
CompletedNCT00184977
COPD on Primary Care Treatment (COOPT)
A Double-blind Placebo-controlled Trial Comparing the Efficacy and Cost-effectiveness of Inhaled Fluticason Propionate Versus Oral N-acetylcysteine in the Treatment of Patients With COPD in General Practice
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 270 (planned)
- Sponsor
- Radboud University Medical Center · Academic / Other
- Sex
- All
- Age
- 30 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this family practice based study is to determine the long-term treatment effects of two drugs that are presumed to modify the course and progression of chronic obstructive pulmonary disease (COPD), oral N-acetylcysteine and inhaled corticosteroids.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a disorder characterised by symptoms and abnormal tests of expiratory flow that do not change markedly over periods of several months observation. COPD includes chronic bronchitis and emphysema. It is not fully clear which medication is the most efficacious in the long-term treatment of COPD. In contrast to asthma, the efficacy and therefore the precise role of inhaled corticosteroids is less clear in the treatment of patients with COPD. The same applies to another (much less investigated) possibility in the treatment of COPD, the anti-oxidant agent N-acetylcysteine. N-acetylcysteine is used as a mucolytic agent in a variety of clinical conditions, such as acute and chronic bronchitis and cystic fibrosis. The aim of this study, which is performed in family practices, is to determine the 3-year treatment effects and cost-effectiveness of oral N-acetylcysteine versus an inhaled corticosteroid (fluticason propionate) in modifying the course and progression of COPD. Comparisons: N-acetylcysteine (oral, 600 mg o.d.) and fluticason propionate (dry powder inhalation, 500 mcg b.i.d.) are compared with placebo
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | N-acetylcysteine | |
| DRUG | fluticasone propionate |
Timeline
- Start date
- 1998-12-01
- Completion
- 2003-01-01
- First posted
- 2005-09-16
- Last updated
- 2010-03-12
Locations
2 sites across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT00184977. Inclusion in this directory is not an endorsement.