Magnussen 2000.

Methods	Study design: randomised controlled, double‐blind, double‐dummy, parallel group Total duration of study: 14 weeks 'Run‐in' period: 4 weeks Number of study centres and locations: 18 pulmonology practices Study setting: pulmonology outpatient practices Withdrawals: none reported Date of study: November 1996 to October 1997
Participants	N: 150 Mean (SD) age, years: 400 μg/day BDP: 43 (15); 1000 μg/day BDP: 42 (15) Age range: not reported Gender ‐ M/F, n: 400 μg/day BDP: 22/50; 1000 μg/day BDP: 30/48 Severity of condition: step 2 Baseline lung function ‐ mean (SE) FEV1, L: 400 μg/day BDP: 2.77 (0.09); 1000 μg/day BDP: 2.85 (0.09) Smoking history: not reported Inclusion criteria and exclusion criteria, allowable range: age 18‐75 years; use of inhaled steroids for ≥ 3 months (BDP 1000 mg or BUD 800‐1000 mg); use of β2‐agonists on demand (≥ 1 puffs/d); reversible airflow obstruction assessed within the last 2 years; change in FEV ≥ 12%; change in PEF ≥ 20%; bronchial hyper‐responsiveness to inhaled histamine (PC20 FEV1 ≥ 4 mg/mL); baseline FEV1 ≥ 60% of predicted; variability of baseline FEV1 during run‐in period ≤ 15% Details of criteria for step‐down treatment: Participants were randomised to step‐down (for eligibility, see inclusion and exclusion criteria).
Interventions	Intervention: hydrofluoroalkane beclomethasone 400 μg/day (i.e. < 50% dose reduction) Comparison: chlorofluorocarbon beclomethasone 1000 μg/day. Concomitant medications: not reported; likely that use of short‐acting bronchodilators as rescue medication was permitted Excluded medications: none specified
Outcomes	Primary outcomes: Efficacy ‐ morning peak flow; Safety ‐ adverse events Secondary outcomes: evening peak flow, FEV1, concentration of inhaled histamine causing a 20% decline in FEV1, frequency of β2‐agonist use, daily asthma symptom score (0 represents no symptoms; 5 represents severe symptoms); and sleep disturbance score. Safety ‐ oropharyngeal candidiasis; reported hoarseness; clinical laboratory tests (i.e. haematology, serum chemistry, urine analysis); and vital signs (i.e. sitting pulse rate, blood pressure, ECG)
Notes	Funding for trial: 3M Medica (Borken, Germany) Notable conflicts of interest of trial authors: not reported; however, several study authors were employees of 3M Medica
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information provided
Allocation concealment (selection bias)	Unclear risk	Insufficient information provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The study was reported as double‐blind.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The study was reported as double‐blind.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Outcome data appear complete. Data appear to be reported for all randomised participants.
Selective reporting (reporting bias)	High risk	Protocol was not available. Reporting of safety results appears to be fairly selective (SAEs not reported, details of individual AEs not reported).
Other bias	Low risk	None identified

Abbreviations: BDP, beclomethasone dipropionate; BID, twice daily; BTS, British Thoracic Society; CFC, chlorofluorocarbon; CIC, ciclesonide; ECG, electrocardiogram; FEV₁, forced expiratory volume in 1 second; FP, fluticasone propionate; FVC, forced vital capacity; GOAL, Gaining Optimal Asthma Control study; ICS, inhaled corticosteroid; LABA, long‐acting beta agonist; NHS, National Health Service; OD, once daily; PC20, provocative concentration that produces a 20% reduction in FEV₁ from baseline value; PEF, peak expiratory flow; PEFR, peak expiratory flow rate; pMDI, pressurised metered‐dose inhaler; QoL, quality of life; R&D, research and development; SD, standard deviation; SE, standard error; SFC, salmeterol formoterol combination; UK, United Kingdom.