Asthma Respiratory Asthma
Conditions
Interventions
Comparison of the effect of increasing regular inhaled corticosteroid four-fold to continuing on same dose in the event of increasing asthma symptoms.
Sponsors
Nottingham City Hospital NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome will be the number of exacerbations requiring oral steroids in the active group compared with the placebo group. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed