Skoner 2011 b.

Methods	DESIGN: a phase III, multi‐centre, randomised, placebo‐controlled, parallel‐group, double‐blind, long‐term safety study
Participants	SYMPTOMATIC PARTICIPANTS RANDOMLY ASSIGNED: N = 98 ANALYSED: N = 73 INTERVENTION: ICS (mometasone furoate 100 μg/d): 48 CONTROL: ICS (mometasone furoate 200 μg/d qd): 50 WITHDRAWALS: reported AGE: mean (range) years INTERVENTION: ICS (mometasone furoate 100 μg/d): 6.4 (4‐9) CONTROL: ICS (mometasone furoate 200 μg/d qd): 6.6 (4‐9) GENDER: male N (%) INTERVENTION: ICS (mometasone furoate 100 μg/d): 34 (70.8) CONTROL: ICS (mometasone furoate 200 μg/d qd): 33 (66) ASTHMA SEVERITY: persistent asthma; severity not reported ASTHMA DURATION: mean (range) years INTERVENTION: ICS (mometasone furoate 100 μg/d): 3.8 (0.67‐8.0) CONTROL: ICS (mometasone furoate 200 μg/d qd): 3.6 (0.42‐8.0) MEAN (± SD) β2‐AGONIST USE (puffs/d): not reported DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: washout period of 3 months ATOPY (% of participants): not reported ELIGIBILITY CRITERIA As above EXCLUSION CRITERIA As above
Interventions	PROTOCOL DURATION Run‐in = 1 to 2 weeks Intervention = 52 weeks DEVICE: dry powder inhaler DOSE OF ICS INTERVENTION: mometasone furoate 100 μg/d qd CONTROL: mometasone furoate 200 μg/d qd CRITERIA FOR WITHDRAWAL FROM STUDY: reported
Outcomes	As above
Notes	As above
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information on sequence generation; randomly assigned in a 1:1:1 ratio to different comparison groups
Allocation concealment (selection bias)	Unclear risk	Insufficient information
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding of participants and key study personnel ensured
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Blinding of participants and key study personnel ensured
Incomplete outcome data (attrition bias) All outcomes	Low risk	No missing outcome data.
Selective reporting (reporting bias)	Low risk	Study protocol not available but published reports include all expected outcomes, including those that were prespecified
Other bias	Low risk	Study apparently free of other sources of bias