Aaronson 1998.
Methods | Setting: multicentre study, USA, hospital outpatient clinic Randomisation: yes, method not stated Allocation concealment: unclear Design: parallel group Length of intervention period: 6 weeks Masking: double blind, double dummy Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score: 3 | |
Participants | 64 adults: 49M 15F
Age range: 18‐56 years
Inclusion criteria:
Adults patients with diagnosis of asthma (not otherwise defined)
FEV1 (% predicted) 65 or greater
Able to use Turbuhaler effectively and achieve inspiratory flow rate of at least 50 litres/min
Exclusion criteria:
Hospitalization due to asthma or respiratory tract infection in last 4 weeks
Serious concurrent illness
Any corticosteroid therapy in last 6 months or investigational drug in last 4 weeks
Significantly abnormal cortisol levels (basal or post cosyntropin)
Pregnancy/lactation Baseline asthma control Symptom frequency: not stated FEV1 (% predicted): >65 |
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Interventions | 1. BUD 200 mcg 2 pfs 2xdaily (800 mcg/d) via Turbuhaler DPI 2. BUD 400 mcg 2pfs 2xdaily (1600 mcg/d) via Turbuhaler DPI 3. BUD 800 mcg 2 pfs 2xdaily (3200 mcg/d) via Turbuhaler DPI all with placebo tablet 1xdaily to maintain blinding |
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Outcomes | Basal plasma cortisol Plasma cortisol at 6 hours following continuous iv cosyntropin infusion, 0.25 mg/500 ml saline over 6 hours Withdrawal due to asthma exacerbation |
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Notes | No reply from author to clarify details of randomisation method. Placebo and oral prednisolone intervention groups were also studies: results not considered here. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |