| Methods |
Randomised, double blind, placebo controlled, parallel group trial.
Minimum dose of steroids identified during screening period. 1 week run‐in, 12 week treatment period. |
| Participants |
19 enrolled, 18 completed protocol from whom data was analysed.
TAO/MP group significantly taller than MP/placebo group, otherwise no demographic differences between groups.
11 male, 7 female.
Age range 6‐17y.
All patients treated ICS,
theophylline and inhaled bronchodilators.
No dose details for ICS.
Mean (SE) daily OCS (mg); TAO/MP 34.2 (9.6); TAO/pred 21.3 (3.1); MP/placebo 23.5 (5.7).
Mean (SE) PEFR (L/min); TAO/MP 368 (39); TAO/pred 313 (41); MP/placebo 313 (36). |
| Interventions |
Randomised to receive TAO/MP, TAO/pred, or MP/placebo. Primary outcomes not stipulated.
First 3 weeks monitored as in‐patients. Thereafter weekly.
Diary cards and PEFR charts.
Steroids tapered on a weekly basis following pre‐set protocol.
Spirometry daily, full lung function and methacholine challenge at baseline and 12 weeks.
Routine liver function and theophylline levels monitored throughout treatment.
Bone densitometry, plasma and urinary cortisol measurements made at baseline and 12 weeks. |
| Outcomes |
Significant reductions in steroid dose in all groups. Comparison of changes between TAO/MP and MP/placebo significant.
FEV1 reduced in TAO/pred (p = 0.025) otherwise no change in lung function. AR to methacholine improved in TAO/MP (p = 0.01). Symptoms reduced by 50% in TAO/MP patients (p = 0.025).
2 patients experienced abnormalities of liver function, one necessitating discontinuation.
No overall significant changes in safety parameters. |
| Notes |
Authors kindly responded to enquiries seeking clarification of data and allocation concealment.
Complete data available for steroid doses, however small sample sizes and widely varying severity/doses made continuous analysis not feasible ‐ treatment effects expressed as dichotomous variable. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
