Pauwels 1997a.

Methods	Formoterol and Corticosteroids Establishing Therapy (FACET) International Study Group Setting: multicentre study (Canada, Europe, Israel) hospital outpatient clinic Randomisation: yes, computer generated sequence Allocation concealment: yes Design: parallel group Length of intervention period: 12 months Masking: double blind Excluded: stated Withdrawals: stated Baseline characteristics: comparable Jadad score: 4
Participants	852 adults: 416 M 436F Age range: 18‐70 years Inclusion criteria: Adult patients with asthma for at least 6 months Treatment with an inhaled corticosteroid for at least 3 months FEV1 (% predicted) 50 or greater 15% or greater improvement in FEV1 following inhaled beta2 agonist Asthma stable by a priori defined criteria. Exclusion criteria: Requirement for > 2000 mcg BDP or 1600 mcg BUD daily via MDI or > 800 mcg BUD or 800 mcg FP via DPI daily. 3 or more courses of oral corticosteroids in past Hospitalized due to asthma in previous 6 months Baseline asthma control Symptom frequency: symptoms well controlled FEV1 (% predicted): > 50
Interventions	1. BUD 100 mcg 2xdaily (200 mcg daily) via Turbuhaler DPI 2. BUD 400 mcg 2xdaily (800 mcg daily) via Turbuhaler DPI
Outcomes	Severe asthma exacerbations/patient/year Mild asthma exacerbations/patient/year Patients without severe exacerbation (%) FEV1 (% predicted) Morning PEFR Daytime asthma symptom score Nighttime asthma symptom score Daytime use of beta2 agonist Nighttime use of beta2 agonists Nighttime awakenings (No. per night) Withdrawal due to asthma exacerbation Hospital admission due to asthma exacerbation
Notes	Reply from author clarifying method of random order generation, use of allocation concealment and provided data for FEV1 and PEFR. Four week run‐in period during which patients received BUD 1600 mcg daily via DPI with terbutaline as needed. Severe exacerbations defined as one requiring oral steroids, decrease on morning PEFR of 30% or more below baseline on two consecutive days. Mild exacerbations defined as morning PEFR 20% or more below baseline, requiring > 3 additional puffs short‐acting beta2 agonist or wakening at night due to asthma. Patients with three or more severe exacerbations within 3 months or a total of 5 or more exacerbations were withdrawn.
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate