COPD on Primary Care Treatment (COOPT)

NCT00184977 | Completed Phase 4

• 2 other identifiers: 98-4614095093 FLU9802 NAC-NL-11
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• exacerbations of COPD, condition-specific quality of life

Secondary Outcomes (1)

• lung function decline, respiratory symptoms

Interventions

N-acetylcysteine DRUG

fluticasone propionate DRUG

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Dutch Health Care Insurance Board (CVZ): collaborator
• GlaxoSmithKline: collaborator
• Zambon SpA: collaborator
• The Netherlands Asthma Foundation: collaborator

Study Sites (2)

Department of Family Medicine, University of Maastricht

Maastricht, 6200 MD, Netherlands

Location

Department of Family Medicine, Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

Location

Related Links

• Department of General Practice/Family Medicine, Radboud University Nijmegen Medical Centre
• Health Care Insurance Board (CVZ)
• Netherlands Asthma Foundation
• Dutch Health Care Inspectorate
• GlaxoSmithKline (study sponsor)
• Zambon Group Spa (Study Sponsor)

MeSH Terms

Conditions

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

Interventions

Acetylcysteine; Fluticasone

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Tjard RJ Schermer, MSc, PhD

  Radboud University Nijmegen Medical Centre, Department of Family Medicine

  PRINCIPAL INVESTIGATOR

• Chris van Weel, MD, PhD

  Radboud University Nijmegen Medical Centre, Department of Family Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: December 1, 1998
• Study Completion: January 1, 2003
• Last Updated: March 12, 2010

Record last verified: 2006-08

Locations

NL (2)