Status:
COMPLETED
Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
British Lung Foundation
GlaxoSmithKline
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
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 lon...
Detailed Description
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 stat...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
March 1 2004
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00440687
Start Date
January 1 2001
End Date
March 1 2004
Last Update
February 27 2007
Active Locations (1)
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1
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