Can acute exacerbations of asthma be prevented with a four-fold increase in inhaled corticosteroid dose?
Completed
- Conditions
- AsthmaRespiratory
- Registration Number
- ISRCTN46018181
- Lead Sponsor
- ottingham City Hospital NHS Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
1. Written Informed consent prior to participation in the trial
2. Male or female patients 16 years of age or older
3. Documented diagnosis of asthma
4. Treatment with 200 to 1000 mcg inhaled beclomethasone dipropionate or equivalent
5. At least one exacerbation requiring a temporary increase in inhaled corticosteroid or oral corticosteroids in the preceding 12 months
6. No oral corticosteroids for 4 weeks prior to or during the run-in period
Exclusion Criteria
1. Other respiratory diagnosis or relevant medical condition
2. Smoking history of greater than 20 pack years
3. Subjects already using a management plan to deal with exacerbations and who would not wish to be randomised to placebo
4. Pregnant or nursing women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be the number of exacerbations requiring oral steroids in the active group compared with the placebo group.
- Secondary Outcome Measures
Name Time Method The total number of exacerbations and days with peak flow less than 15% baseline will also be compared. The sensitivity and specificity of our criteria to detect an exacerbation requiring prednisolone will be determined. The total dose of inhaled and oral corticosteroids used by both groups will be calculated.