Aaronson 1998.
Methods | Setting: multicentre study, USA, hospital outpatient clinics Length of intervention period: 6 weeks Randomisation: yes, method not stated Allocation concealment: unclear Design: parallel 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) Aged 18‐65 years FEV1 (% predicted) 65 or greater Able to use Turbuhaler effectively and achieve inspiratory flow rate of at least 50 L/min Exclusion criteria: Hospitalisation due to asthma or respiratory tract infection in last 4 weeks Other significant disease Any corticosteroid therapy in last 6 months Significantly abnormal cortisol levels (basal or post cosyntropin) | |
Interventions | BUD:
200 mcg 2 pfs 2xdaily (800 mcg/d)
400 mcg 2pfs 2xdaily (1600 mcg/d)
800 mcg 2 pfs 2xdaily (3200 mcg/d) Placebo: 2 pfs 2xdaily Delivery device: Turbuhaler DPI |
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Outcomes | Plasma cortisol at 6 hours following continuous iv cosyntropin infusion, 0.25 mg/500 ml saline over 6 hours (nmol/L) Basal plasma cortisol (nmol/L) | |
Notes | No reply from author to clarify details of randomisation method. Prednisolone treatment arm included in study: results not considered | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | High risk | C ‐ Inadequate |