COPD on Primary Care Treatment (COOPT) - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 12, 2005

Last Updated Date

August 17, 2006

Start Date ^†

December 1998

Current Primary Outcome Measures ^†

exacerbations of COPD, condition-specific quality of life

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00184977 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

lung function decline, respiratory symptoms

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

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

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

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

Intervention ^†

Drug: N-acetylcysteine
Drug: fluticasone propionate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

270

Completion Date

January 2003

Primary Completion Date

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

Gender

Both

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Netherlands

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00184977

Responsible Party

Secondary IDs ^††

95093 FLU9802 NAC-NL-11

Study Sponsor ^†

Radboud University

Collaborators ^††

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

Information Provided By

Radboud University

Verification Date

August 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.