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Sponsors and Collaborators: |
Queen Mary University of London British Lung Foundation GlaxoSmithKline |
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Information provided by: | Queen Mary University of London |
ClinicalTrials.gov Identifier: | NCT00440687 |
Guidelines recommend inhaled corticosteroids (ICS) for patients with moderate to severe chronic obstructive pulmonary disease (COPD). Most COPD patients are managed in primary care and receive ICS long-term and irrespective of severity. The effect of withdrawing ICS from COPD patients in primary care is unknown.This randomised double-blind placebo-controlled trial will evaluate the effect of withdrawal of inhaled corticosteroids in patients with COPD recruited from general practice. Participants will have a clinical and spirometric diagnosis of COPD and will have been prescribed inhaled steroids for the 6 months before entry to the trial. They will be randomised to taking a fixed dose steroid inhaler (Flixotide Accuhaler) or an identical placebo inhaler. Patients will be monitored using diary cards for a year with 3 monthly follow-up visits at their general practice. The primary outcome measures will be exacerbation frequency and severity. Other outcomes are time to first exacerbation, costs, health status, lung function and unscheduled care. We tested the hypothesis that withdrawal of ICS in this population would lead to an increased number of exacerbations, earlier onset of exacerbation, and a worsening of symptoms.
Condition | Intervention | Phase |
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Chronic Obstructive Pulmonary Disease |
Drug: Fluticasone 500mcg BD via accuhaler or identical placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 4 Withdrawal of Inhaled Corticosteroids in Patients With Chronic Obstructive Pulmonary Disease in Primary Care: a Randomised Controlled Trial |
Estimated Enrollment: | 256 |
Study Start Date: | January 2001 |
Estimated Study Completion Date: | March 2004 |
To determine whether withdrawal of inhaled corticosteroids in patients with COPD in general practice effects:
Hypothesis
The withdrawal of inhaled corticosteroids from patients with COPD identified in primary care will cause an increase in frequency and severity of exacerbations and is not cost-effective.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom, London | |
Centre for Health Sciences, Queen Mary’s School of Medicine and Dentistry, Barts and The London, 2 Newark Street,. | |
London and Essex, London, United Kingdom, E1 2AT |
Principal Investigator: | Aklak B Choudhury, MRCP | Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry |
Study Chair: | Gene S Feder, MRCGP MD | Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry |
Study Chair: | Jadwiga A Wedzicha, MRCP MD | Academic Unit of Respiratory Medicine, Royal Free and University College Medical School |
Study Director: | Chris J Griffiths, MRCP MRCGP MD | Centre for Health Sciences, Queen Mary’s School of Medicine and Dentistry |
Study ID Numbers: | QMUL - WISP 01, British Lung Foundation P00/8 |
Study First Received: | February 26, 2007 |
Last Updated: | February 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00440687 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
chronic obstructive pulmonary disease primary care randomised trials therapeutic interventions |
Lung Diseases, Obstructive Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Fluticasone Pulmonary Disease, Chronic Obstructive |
Anti-Inflammatory Agents Respiratory System Agents Autonomic Agents Therapeutic Uses Physiological Effects of Drugs Anti-Asthmatic Agents |
Anti-Allergic Agents Peripheral Nervous System Agents Dermatologic Agents Bronchodilator Agents Pharmacologic Actions |