Status:
COMPLETED
COPD on Primary Care Treatment (COOPT)
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Health Care Insurance Board (CVZ)
GlaxoSmithKline
Conditions:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Eligibility:
All Genders
30-75 years
Phase:
PHASE4
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- age between 30 and 75 years
- being a smoker or ex-smoker
- post-bronchodilator FEV1/FVC ratio is \<88% of the predicted value in case of men or \<89% of the predicted value in case of women
- post-bronchodilator FEV1\>=40% and \<90% of the predicted value
- subjects have a GP diagnosis of COPD or had increased cough, sputum and/or dyspnea on most days for 3 or more months a year, for at least the last 2 years
- able to provide a written informed consent
- expected to be able to comply with the study protocol
- able to communicate with the study personnel and to understand and read instructions
- females of childbearing potential should use an acceptable method for birth control
Exclusion
- a known history of intolerance or allergy for N-acetylcysteine or fluticason
- use of long-term oxygen therapy or expected to be in need of oxygen therapy within the next 3 years
- registered asthma, allergic rhinitis, and/or allergic eczema as an active problem in the GPs records within the last 12 months
- alpha1-antitrypsin deficiency
- cystic fibrosis
- active infection due to Mycobacterium tuberculosis
- status post-lobectomy
- clinically proven gastric or duodenal ulcer in the previous six months
- non-compensated severe chronic congestive heart failure
- life expectancy reduction (e.g. malignancies)
- evidence of illicit drug use or abuse of alcohol intake
- expected not to be compliant in taking medications in general
- being pregnant or giving breastfeeding
- not complying with the inclusion criteria
Key Trial Info
Start Date :
December 1 1998
Trial Type :
INTERVENTIONAL
End Date :
January 1 2003
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT00184977
Start Date
December 1 1998
End Date
January 1 2003
Last Update
March 12 2010
Active Locations (2)
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1
Department of Family Medicine, University of Maastricht
Maastricht, Netherlands, 6200 MD
2
Department of Family Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB