Gradman 2010.

Methods	Design: single‐centre, randomised, open‐label, parallel‐group, controlled trial Sponsor: Fonden til faglig udvikling af speciallægepraksis, Toyota‐Fonden Denmark, Else & Helene Alstrup’s Fond, Lily Benthine Lund’s Fond, Johannes M. Klein’s Fond and A. and J. Rasmussens Fond
Participants	Setting: Children's Clinic Randers, Randers, Denmark Eligible: 52 Randomly assigned: 22 (budesonide 200 μg); 21 (montelukast 5 mg) Gender (male): 71.15% Age, years, mean (range): budesonide 9.2 (5–11); montelukast 8.8 (5–11) Inclusion criteria: prepubertal (5‐11 years) children with mild persistent asthma according to GINA guidelines; Tanner stage 1, with height and weight in the 3rd–97th percentile range for age and gender according to Danish standard charts; no use of systemic corticosteroids within the previous 4 weeks; no concurrent disease or medications that might affect growth; appropriate inhaler technique and ability to cooperate to knemometry Exclusion criteria: individuals required to use intranasal, oral or parenteral corticosteroids during the trial Previous regular use of ICS: 88% in the budesonide group; 78% in the montelukast group
Interventions	Test group: Budesonide, 200 μg/d Control group: Montelukast, 5 mg/d Budesonide was given via DPI, and treatment was given once daily for 52 weeks
Outcomes	Change in height over a 1‐year period (cm) Change in lower leg length (mm) Height was measured in triplicate by the same experienced observer with a wall‐mounted Harpenden stadiometer
Notes	Adherence to study treatment was recorded in a diary and confirmed by counting the number of remaining tablets (Singulair) or by reading the dose counter (Pulairmax). Compliance rate was 95%‐98% in the budesonide group and 95%‐96% in the montelukast 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	High risk	Open‐label
Blinding of outcome assessment (detection bias) All outcomes	High risk	Open‐label
Incomplete outcome data (attrition bias) All outcomes	Low risk	No withdrawal reported
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