Berend 2001.
| Methods | Setting: multicentre study Australia, hospital outpatient clinics Design: parallel group Length of intervention period: 6 months Randomisation: yes, method not stated Allocation concealment: unclear Masking: open, non‐blinded Excluded: not stated Withdrawals: not stated Baseline characteristics: comparable Jadad score: 1 | |
| Participants | 133 adults: 64M 69F Age range: 20 to 78 years Inclusion criteria: Adults requiring BDP or BUD > 1750 mcg/d for asthma control One or more of following: 190ml or greater FEV1 reversibility after inhaled beta2 agonist Asthma symptoms on 2 or more days/week for 2 weeks in last month Night‐time symptoms 2 or more nights/week Diurnal PEFR variability 15% or greater Exclusion criteria: Regular oral steroid therapy Significant co‐existent disease | |
| Interventions | FP: half usual maintenance dose (mcg/d) via MDI + spacer BDP or BUD: usual maintenance dose via MDI+ spacer or Turbuhaler DPI |
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| Outcomes | FEV1 FVC Morning PEFR Clinic PEFR HRQOL: Change in Asthma Quality of Life Questionnaire domain scores compared to baseline HRQOL: Change in Short‐form 36 questionnaire domain scores compared to baseline Morning plasma cortisol Urine cortisol:creatinine ratio (1 hour post waking sample) Asthma exacerbations Local oral side‐effects Extent and ease of skin bruising Biochemical markers of bone turnover | |
| Notes | Study in abstract form until 2001, full published version available for 2004 update. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Unclear risk | Described as randomised; other information not available |
| Allocation concealment? | Unclear risk | Information not available |
| Blinding? All outcomes | High risk | Open label |