COPD on Primary Care Treatment (COOPT)

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborators: Dutch Health Care Insurance Board (CVZ); GlaxoSmithKline; The Netherlands Asthma Foundation; Zambon SpA
• Treatments: Acetylcysteine; Fluticasone; N-monoacetylcystine; Xhance

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