COPD on Primary Care Treatment (COOPT) - Full Text View

Sponsors and Collaborators:	Radboud University Dutch Health Care Insurance Board (CVZ) GlaxoSmithKline Zambon SpA The Netherlands Asthma Foundation
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00184977

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 IV

MedlinePlus related topics: Bronchitis COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone Fluticasone propionate Acetylcysteine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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

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

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

Department of General Practice/Family Medicine, Radboud University Nijmegen Medical Centre This link exits the ClinicalTrials.gov site

Department of General Practice/Family Medicine, University of Maastricht This link exits the ClinicalTrials.gov site

Health Care Insurance Board (CVZ) This link exits the ClinicalTrials.gov site

Netherlands Asthma Foundation This link exits the ClinicalTrials.gov site

Dutch Health Care Inspectorate This link exits the ClinicalTrials.gov site

GlaxoSmithKline (study sponsor) This link exits the ClinicalTrials.gov site

Zambon Group Spa (Study Sponsor) This link exits the ClinicalTrials.gov site

Study ID Numbers:	98-46140, 95093 FLU9802 NAC-NL-11
Study First Received:	September 12, 2005
Last Updated:	August 17, 2006
ClinicalTrials.gov Identifier:	NCT00184977
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

Study placed in the following topic categories:

Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Acetylcysteine
Fluticasone
Chronic Disease
Bronchitis
N-monoacetylcystine
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Anti-Infective Agents
Disease Attributes
Antioxidants
Bronchial Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents
Antiviral Agents

Protective Agents
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Expectorants
Therapeutic Uses
Free Radical Scavengers
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Antidotes

ClinicalTrials.gov processed this record on January 14, 2009