| Methods |
Randomised, double blind, placebo controlled, parallel group trial.
Steroid tapering during 3 months prior to trial.
Treatment phase for 1 year, some subjects continued on trial treatment for a second year. |
| Participants |
75 patients enrolled, 57 completed 1 year of treatment from whom data was analysed.
No demographic differences between groups.
Age 21‐75y.
19 male, 38 female.
None of the patients were taking ICS, stipulated in entry criteria. All received theophylline.
Mean (SE) dose (mg) MP at baseline; TAO/MP 30.8 (12.4); MP/placebo 32
(2.5).
No data on baseline lung function given. |
| Interventions |
Randomised to receive TAO/MP or MP/placebo over 1(2) years.
TAO 250mg daily.
Primary outcomes; hospitalisation, ER visits, 'acute steroid boosts', and lowest stable daily steroid dose.
Methacholine challenge measured but no attempts to compare symptoms or PEFR. symptoms |
| Outcomes |
Significant reductions in steroid dose achieved in both groups. Comparison (of changes in dose from baseline) between groups significant (p = 0.03). NS when groups compared cf changes from mean steroid requirements over preceding year.
Significant reductions in admissions, ER, steroid boosts.
No differences between groups for these parameters.
No changes in AR to methacholine. |
| Notes |
Authors kindly responded to enquiries seeking clarification of data and allocation concealment.
Complete individual data obtained for steroid doses, no data available to allow calculation of SD for symptoms (not measured), lung function or exacerbations. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Information not available (Cochrane Grade B) |
