COPD on Primary Care Treatment (COOPT)

Radboud University Medical Center

Status and phase

Completed

Phase 4

Conditions

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Bronchitis, Chronic

Treatments

Drug: fluticasone propionate

Drug: N-acetylcysteine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00184977

95093 FLU9802 NAC-NL-11

98-46140

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

30 to 75 years old

Volunteers

No Healthy Volunteers

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