Barnes 1993.

Methods	Setting: multicentre study Europe, hospital outpatient clinic Design: parallel group Length of intervention period: 6 weeks Randomisation: yes, computer generated sequence Allocation concealment: yes (coded, sealed envelopes) Masking: double blind Excluded: stated Withdrawals: stated Baseline characteristics: comparable Jadad score: 4
Participants	154 adults randomised. FEV1: 2.95 (SD 0.83) (FEV1 % predicted: 80.0 (SD 21.4)); Mean FVC: 4.42 L (SD 0.94). 8 females. Inclusion criteria: either sex; 18‐60 years of age; ATS defined asthma; = 40% predicted value; Either post‐BD increase in FEV1 of at least 200ml or = 12% of baseline, OR dirunal variation of PEF = 15% on at least 2 days/week during run‐in. Exclusion criteria: Exacerbation 4 weeks before inclusion; use of oral steroids within 6 months ; use of ICS/other systemic steroids within 4 weeks
Interventions	FP: 250 mcg 2 puffs 2xdaily (1000 mcg/d) BDP: 250 mcg 4 puffs 2xdaily (2000 mcg/d) Delivery device: MDI
Outcomes	FEV1 (% predicted) FVC (% predicted) PEFR (% predicted) Morning PEFR Evening PEFR Diurnal variation in PEFR % symptom‐free days % symptom‐free nights % beta2‐agonist free days % beta‐2 agonist nights Daytime beta2 agonist use (puffs) Night‐time beta2 agonist use (puffs) Oral candidiasis Upper respiratory tract infection Oropharyngeal side effects Plasma cortisol (sample time during day not specified)
Notes	Details concerning randomisation method provided by Glaxo Wellcome
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Low risk	See Appendix 2
Allocation concealment?	Low risk	See Appendix 2
Blinding? All outcomes	Low risk	Identical inhaler devices