COPD on Primary Care Treatment (COOPT)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Pulmonary Disease, Chronic Obstructive; Lung Diseases, Obstructive; Bronchitis, Chronic	Drug: N-acetylcysteine; Drug: fluticasone propionate	Phase 4

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	270 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double
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
Study Start Date :	December 1998
Study Completion Date :	January 2003

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. exacerbations of COPD, condition-specific quality of life

Secondary Outcome Measures :

1. lung function decline, respiratory symptoms

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Additional Information:

Department of General Practice/Family Medicine, Radboud University Nijmegen Medical Centre 

Department of General Practice/Family Medicine, University of Maastricht 

Netherlands Asthma Foundation 

Dutch Health Care Inspectorate 

GlaxoSmithKline (study sponsor) 

Zambon Group Spa (Study Sponsor) 

ClinicalTrials.gov Identifier:	NCT00184977 History of Changes
Other Study ID Numbers:	98-46140; 95093 FLU9802 NAC-NL-11
First Posted:	September 16, 2005
Last Update Posted:	March 12, 2010
Last Verified:	August 2006

Keywords provided by Radboud University:

Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trial; Family Practice; Respiratory Function Tests; Health Status

Additional relevant MeSH terms:

Lung Diseases; Chronic Disease; Pulmonary Disease, Chronic Obstructive; Bronchitis; Lung Diseases, Obstructive; Bronchitis, Chronic; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Bronchial Diseases; Respiratory Tract Infections; Fluticasone; Acetylcysteine; N-monoacetylcystine; Anti-Inflammatory Agents	Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents; Anti-Allergic Agents; Antiviral Agents; Anti-Infective Agents; Expectorants; Free Radical Scavengers; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents