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COPD on Primary Care Treatment (COOPT)

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Bronchitis, Chronic

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
N-acetylcysteine
fluticasone propionate
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Randomized Controlled Trial, Family Practice, Respiratory Function Tests, Health Status

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Family Medicine, University of Maastricht
  • Department of Family Medicine, Radboud University Nijmegen Medical Centre

Outcomes

Primary Outcome Measures

exacerbations of COPD, condition-specific quality of life

Secondary Outcome Measures

lung function decline, respiratory symptoms

Full Information

First Posted
September 12, 2005
Last Updated
March 11, 2010
Sponsor
Radboud University Medical Center
Collaborators
Dutch Health Care Insurance Board (CVZ), GlaxoSmithKline, Zambon SpA, The Netherlands Asthma Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00184977
Brief Title
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

2. Study Status

Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Dutch Health Care Insurance Board (CVZ), GlaxoSmithKline, Zambon SpA, The Netherlands Asthma Foundation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Bronchitis, Chronic
Keywords
Pulmonary Disease, Chronic Obstructive, Randomized Controlled Trial, Family Practice, Respiratory Function Tests, Health Status

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
270 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Type
Drug
Intervention Name(s)
fluticasone propionate
Primary Outcome Measure Information:
Title
exacerbations of COPD, condition-specific quality of life
Secondary Outcome Measure Information:
Title
lung function decline, respiratory symptoms

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tjard RJ Schermer, MSc, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Centre, Department of Family Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris van Weel, MD, PhD
Organizational Affiliation
Radboud University Nijmegen Medical Centre, Department of Family Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Department of Family Medicine, University of Maastricht
City
Maastricht
ZIP/Postal Code
6200 MD
Country
Netherlands
Facility Name
Department of Family Medicine, Radboud University Nijmegen Medical Centre
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands

12. IPD Sharing Statement

Links:
URL
http://www.umcn.nl/Pages/default.aspx
Description
Department of General Practice/Family Medicine, Radboud University Nijmegen Medical Centre
URL
http://www.cvz.nl/
Description
Health Care Insurance Board (CVZ)
URL
http://www.astmafonds.nl
Description
Netherlands Asthma Foundation
URL
http://www.igz.nl
Description
Dutch Health Care Inspectorate
URL
http://www.gsk.com
Description
GlaxoSmithKline (study sponsor)
URL
http://www.zambongroup.com
Description
Zambon Group Spa (Study Sponsor)

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COPD on Primary Care Treatment (COOPT)

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