COPD on Primary Care Treatment (COOPT)

This study has been completed.
Sponsor:
Collaborators:
Dutch Health Care Insurance Board (CVZ)
GlaxoSmithKline
Zambon SpA
The Netherlands Asthma Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00184977
First received: September 12, 2005
Last updated: March 11, 2010
Last verified: August 2006
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchitis, Chronic
Drug: N-acetylcysteine
Drug: fluticasone propionate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • exacerbations of COPD, condition-specific quality of life

Secondary Outcome Measures:
  • lung function decline, respiratory symptoms

Estimated Enrollment: 270
Study Start Date: December 1998
Estimated Study Completion Date: January 2003
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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184977

Locations
Netherlands
Department of Family Medicine, University of Maastricht
Maastricht, Netherlands, 6200 MD
Department of Family Medicine, Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Dutch Health Care Insurance Board (CVZ)
GlaxoSmithKline
Zambon SpA
The Netherlands Asthma Foundation
Investigators
Principal Investigator: Tjard RJ Schermer, MSc, PhD Radboud University Nijmegen Medical Centre, Department of Family Medicine
Study Director: Chris van Weel, MD, PhD Radboud University Nijmegen Medical Centre, Department of Family Medicine
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00184977     History of Changes
Other Study ID Numbers: 98-46140, 95093 FLU9802 NAC-NL-11
Study First Received: September 12, 2005
Last Updated: March 11, 2010
Health Authority: Netherlands: Dutch Health Care Inspectorate

Keywords provided by Radboud University:
Pulmonary Disease, Chronic Obstructive
Randomized Controlled Trial
Family Practice
Respiratory Function Tests
Health Status

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Acetylcysteine
N-monoacetylcystine
Fluticasone
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 20, 2014