| Methods |
Randomised, double‐blind, parallel group. 4 week run‐in, 36 week treatment, 8 week double blind placebo phase and 4 week run‐out. |
| Participants |
39 patients enrolled, data from 36 was used in the assessment of steroid dose reduction.
Mean age 50y (26‐66)
19 men, 17 women
Non‐smokers
Mean (range) daily OCS; CyA, 11mg (5‐20):Placebo 12mg (5‐22.5).
Mean daily ICS 2.1mg.
Mean (SE), & % predicted FEV1;CyA 1.69(0.15) 63.3%: Placebo 2.02L(0.16) 68.7%
Mean(SE) & % predicted FVC; CyA 2.89L(0.19) 80%:Placebo 3.35L(0.26) 83%. |
| Interventions |
Pre‐trial tapering OCS.
Randomised to CyA 5mg/kg or placebo.
Reviewed every 14d, prednisolone dosage reduced if asthma stable by between 1.25 and 5mg per week as per pre‐set protocol.
Primary outcome variable ‐ lowest dose of steroid (maintained for two weeks) during treatment phase. |
| Outcomes |
Median reduction prednisolone expressed as a % of baseline; CyA 62%, placebo 25%. CyA allowed a 25% reduction in excess of that seen in placebo (p<0.043).
Total dose prednisolone during treatment; CyA 2484mg;placebo 3592mg (p=0.049).
Fewer exacerbations in CyA treated patients (2.69/patient cf 3.55/patient) p= NS.
Mean morning PEFR increased significantly in CyA patients, no change placebo (p=0.026 between groups).
Neither treatment changed mean FEV1,FVC,PEFR variability, or beta‐agonist reversibility.
Mean CyA level 144ng/mL. |
| Notes |
Paper analysed best 2 weeks.
Inadequate information regarding allocation concealment. Authors did not respond to correspondence seeking clarification.
No end of treatment doses of prednisolone given.
Initial ICS dose not stated.
Results given as SEM converted to SD for analysis. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Described as randomised; other information not available |
