| Methods |
Randomised, double blind, placebo controlled, parallel groups trial. Threshold doses of prednisolone identified during pre‐trial screening. Two week treatment period. |
| Participants |
18 patients enrolled, 15 completed protocol from whom the data was analysed.
No demographic differences between groups stated.
9 male, 6 female.
Mean (SD) age, 13.5y (2.58).
Maintained on ICS (no dose details) and theophylline, inhaled bronchodilators.
Mean(SD) dose prednisolone, 31mg (17.8).
Mean (SD) % predicted FEV1, 83% (20.4). |
| Interventions |
Randomised to receive TAO/MP, MP/placebo TAO/pred.
TAO 250mg daily.
Primary outcomes not stipulated.
Assessed daily.
Steroids tapered from day 3 to 14.
Spirometry, methacholine challenge and glucocorticoid kinetic studies done at day baseline and day 14. |
| Outcomes |
All patients reduced steroid dose by at least 50%. No changes in lung function or increase in reported symptoms in any group.
AR improved in TAO/MP and TAO/pred (NS).
Long term follow up showed enduring benefits in patients maintained on TAO/MP.
TAO well tolerated. |
| Notes |
Inadequate information regarding allocation concealment. Authors did not respond to enquiries seeking clarification.
Insufficient data available to calculate SD for asthma control or exacerbations. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
