Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Queen Mary University of London
With
British Lung Foundation
GlaxoSmithKline
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.
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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)
Clareo Health | Withdrawal of Inhaled Corticosteroids in Patients With COPD in Primary Care
