COPD on Primary Care Treatment (COOPT)
This study has been completed.
Sponsor:
Radboud University
Collaborators:
Dutch Health Care Insurance Board (CVZ)
GlaxoSmithKline
Zambon SpA
The Netherlands Asthma Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00184977
First received: September 12, 2005
Last updated: March 11, 2010
Last verified: August 2006
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
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 |
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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184977
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184977
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
Additional Information:
| ClinicalTrials.gov Identifier: | NCT00184977 History of Changes |
| Other Study ID Numbers: | 98-46140 95093 FLU9802 NAC-NL-11 |
| Study First Received: | September 12, 2005 |
| Last Updated: | March 11, 2010 |
| 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 |
Additional relevant MeSH terms:
|
Lung Diseases Bronchitis Chronic Disease Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchitis, Chronic Respiratory Tract Diseases Bronchial Diseases Respiratory Tract Infections Disease Attributes Pathologic Processes 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 |
ClinicalTrials.gov processed this record on September 29, 2016