COPD on Primary Care Treatment (COOPT)

March 11, 2010 updated by: Radboud University Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment

270

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6200 MD
        • Department of Family Medicine, University of Maastricht
      • Nijmegen, Netherlands, 6500 HB
        • Department of Family Medicine, Radboud University Nijmegen Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
exacerbations of COPD, condition-specific quality of life

Secondary Outcome Measures

Outcome Measure
lung function decline, respiratory symptoms

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

GlaxoSmithKline
Zambon SpA
The Netherlands Asthma Foundation
Dutch Health Care Insurance Board (CVZ)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 1998

Study Completion

January 1, 2003

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

March 12, 2010

Last Update Submitted That Met QC Criteria

March 11, 2010

Last Verified

August 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-46140
  • 95093 FLU9802 NAC-NL-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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