Clinical trial NCT00184977: COPD on Primary Care Treatment (COOPT)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchitis, Chronic
Keywords: Pulmonary Disease, Chronic Obstructive
Randomized Controlled Trial
Family Practice
Respiratory Function Tests
Health Status
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Health Care Insurance Board (CVZ)
name: GlaxoSmithKline
name: Zambon SpA
name: The Netherlands Asthma Foundation
First posted: 2005-09-16
Enrollment: 270
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: exacerbations of COPD, condition-specific quality of life
Secondary outcomes:
measure: lung function decline, respiratory symptoms
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Department of Family Medicine, University of Maastricht
city: Nijmegen
country: Netherlands
facility: Department of Family Medicine, Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Nijmegen Medical Centre, Department of Family Medicine
name: Tjard RJ Schermer, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen Medical Centre, Department of Family Medicine
name: Chris van Weel, MD, PhD
role: STUDY_DIRECTOR
References: