Skoner 2011.

Methods	Design: phase III, multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: Merck & Co, Inc
Participants	Setting: multi‐centres in the USA Eligible: not reported Randomly assigned: 48 (mometasone 100 μg QD); 44 (mometasone 100 μg BID); 50 (mometasone 200 μg QD); 45 (placebo) Analysed: 48 (mometasone 100 μg QD); 44 (mometasone 100 μg BID); 50 (mometasone 200 μg QD); 45 (placebo) Gender (male): 70.1% Age, years, mean: 6.5 Inclusion criteria: children 4–9 years of age with history of asthma ≥ 6 months; FEV1 ≥ 75% predicted value at both screening visit and baseline visit (for children 4–5 years of age, FEV1 ≥ 75% predicted value for any single measurement, or average morning PEF ≥ 75% predicted normal at screening or baseline); normal height (5th–95th percentiles on standard growth charts) upon measurement with a stadiometer; skeletal age within 2 years of chronological age; morning plasma cortisol levels ≥ 5 μg/dL; no greater than stage 1 in the Tanner Classification of Sex Maturity Exclusion criteria: increase or decrease in FEV1 ≥ 20% between screening and baseline visits; ≥ 12 puffs per day of albuterol on any 2 consecutive days between screening and baseline visits; inpatient hospitalisation for asthma control within the previous 3 months; ventilator support for respiratory failure secondary to asthma within the previous 5 years; hospital admission for management of airway obstruction on 2 or more occasions over the past 6 months; asthma requiring daily use of nebulised short‐acting β2‐agonist or any use of long‐acting β2‐agonists; asthma requiring long‐term use of inhaled or systemic corticosteroids; inability to use a DPI device or a peak flow meter; history or evidence of abnormal growth; presence of any disease or condition with the potential to substantially affect growth or requiring concomitant corticosteroid therapy; evidence of gross malnutrition; history of any disease that could have interfered with study evaluations; upper or lower respiratory tract infection within 2 weeks of screening and baseline visits Previous regular use of ICS: not allowed
Interventions	Test group: Mometasone, 100 μg/d, once daily Mometasone, 200 μg/d, twice daily Mometasone, 200 μg/d, once daily Control group: matching placebo Treatment was given via DPI for 52 weeks
Outcomes	Linear growth velocity (cm/y) Change from baseline in markers of hypothalamic–pituitary–adrenal (HPA) axis and bone formation/resorption Height was measured using a Harpenden stadiometer, and a mean of 3 values was recorded. When possible, the same study personnel performed height measurements for a given participant throughout the study, at approximately the same time of day for each visit
Notes	Treatment compliance was assessed by diary. Compliance rate ranged from 75%‐83% in the mometasone groups and 89% in the placebo group
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details provided
Allocation concealment (selection bias)	Unclear risk	No details provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Use of matching placebo
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Use of matching placebo
Incomplete outcome data (attrition bias) All outcomes	High risk	Withdrawal rate was 52/187 (27.8%)
Selective reporting (reporting bias)	Low risk	Study protocol is not available, but published reports include all expected outcomes, including those that were prespecified
Other bias	Low risk	Study appears to be free of other sources of bias