| Methods |
Randomised, double blind, placebo controlled study.
12 week screening period when tapering of steroid dose was undertaken, 4 week baseline period, 24 week treatment phase, and 4 week run out period. |
| Participants |
334 patients screened, 140 randomised to gold, 139 to placebo.
146 men,133 women.
Mean age (SD); gold, 52.9y(13.5): placebo, 50.5y(12.8).
Variable ICS, no nos. or dose details given.
Mean prednisolone dose not given,
66% gold patients and 68% placebo maintained on 10‐19mg steroid per day.
FEV1 %predicted; gold 64%: placebo 63%. |
| Interventions |
Randomised to auranofin 3mg twice daily or placebo.
Primary outcome ‐ therapeutic success, defined as 50% reduction in steroid dose cf baseline
Secondary outcomes ‐ spirometry, PEFR, symptoms, beta agonist use, global assessments of asthma control.
First 12 weeks of treatment no change to steroid dose attempted. Second 12 week period of treatment, steroids reduced as per pre‐set protocol.
Symptom cards, daily PEFR and clinic visits every 4 weeks. |
| Outcomes |
Therapeutic success achieved in 41% gold patients and 27% placebo (p = 0.01).
Lung function maintained.
No difference between groups with respect to other parameters. |
| Notes |
Inadequate information regarding allocation concealment. Senior author kindly responded to enquiries seeking clarification but did not have access to study file and subsequent efforts to access this have been unsuccessful. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Described as randomised; other information not available |
