Lorentzen 1996.

Methods	Setting: multicentre study Europe, hospital outpatient clinic Design: parallel group Length of intervention period: 12 months Randomisation: yes, computer generated sequence Allocation concealment: yes (central coding by pharmaceutical company sponsors) Masking: double blind Excluded: not stated Withdrawals: stated Baseline characteristics: comparable Jadad score: 5
Participants	213 patients randomised 104 male 109 female Age range: 18 to 77 years Inclusion criteria: Clinical history of severe chronic asthma Requiring and responding to inhaled beta2 agonists and high doses of ICS No change in regular asthma medication for at least one month Exclusion criteria: Recent hospital admission due to asthma Systemic corticosteroids or respiratory tract infection within last month Hypersensitivity to corticosteroids Pregancy Inability to use aersol MDI
Interventions	FP: 250 mcg 2 puffs 2xdaily (1000 mcg/d) BDP: 250mcg 4 puffs 2xdaily (2000 mcg/d) Delivery device: MDI
Outcomes	Morning plasma cortisol FEV1 FVC Clinic PEFR Oral Candidiasis Oropharyngeal side effects Asthma exacerbations (No. of patients)
Notes	Details of 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