COPD on Primary Care Treatment (COOPT)
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ClinicalTrials.gov Identifier: NCT00184977 |
Recruitment Status
:
Completed
First Posted
: September 16, 2005
Last Update Posted
: March 12, 2010
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Bronchitis, Chronic | Drug: N-acetylcysteine Drug: fluticasone propionate | Phase 4 |
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 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 |

- exacerbations of COPD, condition-specific quality of life
- lung function decline, respiratory symptoms

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Ages Eligible for Study: | 30 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184977
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 |
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 |
Additional Information:
ClinicalTrials.gov Identifier: | NCT00184977 History of Changes |
Other Study ID Numbers: |
98-46140 95093 FLU9802 NAC-NL-11 |
First Posted: | September 16, 2005 Key Record Dates |
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 |