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. 2007 Oct 17;2007(4):CD002310. doi: 10.1002/14651858.CD002310.pub4

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
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