| Methods |
Randomised, double blind, placebo controlled, parallel group study. One week run‐in, 26 week treatment phase. |
| Participants |
32 patients enrolled, data evaluated from 28 patients who completed the study.
17 men,15 women.
Mean age (range), 52.4y (28‐72).
3 patients not using ICS (not tolerated), remainder treated with a minimum of 800micograms daily.
Mean dose (SD) prednisolone (mg); gold, 7.6(5.31): placebo, 9.4(4.47).
Mean % predicted FEV1 (range); gold, 59.8 (14‐100): placebo, 59.7 (33‐97).
2 smokers |
| Interventions |
Randomised to Auranofin 3mg twice daily or placebo.
Visits to clinic every 2 weeks.
If stable after 12 weeks treatment, taper steroids by 2.5mg per week.
Diary cards and spirometry. |
| Outcomes |
Mean (SD) prednisolone dose (mg) for fist 2 weeks and last 2 weeks of treatment; gold 9.3(6.34) and 5.3(6.19) respectively (p = 0.007):placebo 11.0(6.35) and 10.0(7.33) respectively (p = 0.48). Between group comparison p = 0.056.
Mean % predicted (SE) FEV1 at baseline and end of treatment; gold 59.8%(26.8) and 66.2%(29.6) respectively: placebo 59.7%(19.45) and 50.2%(14) respectively. Differences between groups for FEV1 significant.
Significant differences for symptoms in favour of gold. |
| Notes |
Inadequate information regarding allocation concealment. Authors did not respond to correspondence seeking clarification. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
Described as randomised; other information not available |
