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 |
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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 |
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Interventions | Test group:
Control group:
Budesonide was given via DPI, and treatment was given once daily for 52 weeks |
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Outcomes |
Height was measured in triplicate by the same experienced observer with a wall‐mounted Harpenden stadiometer |
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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 |