Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care
NCT ID: NCT00440687
Last Updated: 2007-02-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
256 participants
Study Classification
INTERVENTIONAL
Study Start Date
2001-01-31
Study Completion Date
2004-03-31
Brief Summary
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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.
Detailed Description
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To determine whether withdrawal of inhaled corticosteroids in patients with COPD in general practice effects:
* the frequency of exacerbations compared to a control group
* differences in health status compared to a control group
* differences in lung function compared to a control group
* changes in unscheduled care compared to a control group
* Direct and indirect costs compared to a control group
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.
* the frequency of exacerbations compared to a control group
* differences in health status compared to a control group
* differences in lung function compared to a control group
* changes in unscheduled care compared to a control group
* Direct and indirect costs compared to a control group
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.
Conditions
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Chronic Obstructive Pulmonary Disease
Keywords
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chronic obstructive pulmonary disease
primary care
randomised trials
therapeutic interventions
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Interventions
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Fluticasone 500mcg BD via accuhaler or identical placebo
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Smoker or ex smoker of at least 10 pack years
* Age 40 or above
* Prior and current use of inhaled corticosteroids for at least 6 months duration (Used for at least 75% of time on direct questioning)
* FEV1 \<80% of predicted, FEV1/FVC ratio \<70%.
* Less than 15% change and \<200 mls change in FEV1 20 minutes after 5 mg nebulised salbutamol.
* 256 patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year
* Age 40 or above
* Prior and current use of inhaled corticosteroids for at least 6 months duration (Used for at least 75% of time on direct questioning)
* FEV1 \<80% of predicted, FEV1/FVC ratio \<70%.
* Less than 15% change and \<200 mls change in FEV1 20 minutes after 5 mg nebulised salbutamol.
* 256 patients to be included in trial of which 196 must have had a precious exacerbation of COPD in the last year
Exclusion Criteria
* Clear history of asthma, bronchiectasis, carcinoma of bronchus or other significant respiratory disease
* Inability to give informed consent (severe mental illness, mental handicap or brain damage).
* Recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation)
* Classification as a never smoker
* Strongly positive skin allergy result (\>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status)
* Inability to give informed consent (severe mental illness, mental handicap or brain damage).
* Recorded exacerbation within last month that has required antibiotics or steroids (delayed randomisation)
* Classification as a never smoker
* Strongly positive skin allergy result (\>10mm skin weal greater then negative control) to house dust mite, grass, tree, aspergillus, cat, dog or weed (irrespective of asthma/atopy status)
Minimum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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British Lung Foundation
OTHER
Sponsor Role
collaborator
GlaxoSmithKline
INDUSTRY
Sponsor Role
collaborator
Queen Mary University of London
OTHER
Sponsor Role
lead
Principal Investigators
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Aklak B Choudhury, MRCP
Role: PRINCIPAL_INVESTIGATOR
Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry
Gene S Feder, MRCGP MD
Role: STUDY_CHAIR
Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry
Jadwiga A Wedzicha, MRCP MD
Role: STUDY_CHAIR
Academic Unit of Respiratory Medicine, Royal Free and University College Medical School
Chris J Griffiths, MRCP MRCGP MD
Role: STUDY_DIRECTOR
Centre for Health Sciences, Queen Mary's School of Medicine and Dentistry
Locations
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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
Site Status
Countries
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United Kingdom
References
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Wouters EF, Postma DS, Fokkens B, Hop WC, Prins J, Kuipers AF, Pasma HR, Hensing CA, Creutzberg EC; COSMIC (COPD and Seretide: a Multi-Center Intervention and Characterization) Study Group. Withdrawal of fluticasone propionate from combined salmeterol/fluticasone treatment in patients with COPD causes immediate and sustained disease deterioration: a randomised controlled trial. Thorax. 2005 Jun;60(6):480-7. doi: 10.1136/thx.2004.034280.
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Choudhury AB, Dawson CM, Kilvington HE, Eldridge S, James WY, Wedzicha JA, Feder GS, Griffiths CJ. Withdrawal of inhaled corticosteroids in people with COPD in primary care: a randomised controlled trial. Respir Res. 2007 Dec 27;8(1):93. doi: 10.1186/1465-9921-8-93.
Reference Type
DERIVED
Other Identifiers
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British Lung Foundation P00/8
Identifier Type: -
Identifier Source: secondary_id
QMUL - WISP 01
Identifier Type: -
Identifier Source: org_study_id