CAMP 2000.

Methods	Design: multi‐centre, randomised, double‐blind, parallel‐group, placebo‐controlled trial Sponsor: National Heart, Lung and Blood Institute, USA
Participants	Setting: 8 clinical centres in the USA Eligible: 1041 Randomly assigned: 311 (budesonide 200 μg); 312 (nedocromil sodium 8 mg); 418 (placebo) Analysed: 98,4% (budesonide 200 μg); 98.4% (nedocromil sodium 8 mg); 98.3% (placebo) Gender (male): 58.2% (budesonide); 66% (nedocromil); 56% (placebo) Age, years, mean ± SD: budesonide 9.0 ± 2.1; nedocromil 8.8 ± 2.1; placebo 9.0 ± 2.2 Inclusion criteria: children 5 to 12 years of age with mild to moderate asthma (defined by presence of symptoms or by use of an inhaled bronchodilator at least twice weekly or use of daily medication for asthma) at least 6 months in the year before the interview; methacholine reactivity (FEV1, PC20) no greater than 12.5 mg/mL Exclusion criteria: severe asthma (2 or more hospitalisations for asthma in the past year, 6 or more steroid bursts in the past year, intubation for asthma at any time in the past); presence of 1 or more of the following confounding or complicating conditions: other active pulmonary disease; pulmonary function suggesting a ventilatory defect or evidence of irreversible lung disease; severe chronic sinusitis or nasal polyposis; introduction of or change in allergen immunotherapy in the month before the interview; use of more than 4 sprays of nasal steroids daily (only beclomethasone allowed) at the time of random assignment; current use of cimetidine, metoclopramide, ranitidine or other treatment for gastroesophageal reflux; participation in another pharmaceutical, immunotherapy, respiratory or asthma study; pregnancy; inability to perform acceptable spirometry; inability to complete the methacholine challenge Previous regular use of ICS: 40.5% in the budesonide group; 36.5% in the nedocromil group; 35.9% in the placebo group
Interventions	Test group: Budesonide, 400 μg/d Nedocromil sodium, 16 μg/d Control group: matching placebos Budesonide was delivered via Turbuhaler, and nedocromil was delivered via Tilade‐MDI, twice daily. Treatment duration ranged from 4‐6 years
Outcomes	Efficacy outcomes Linear growth velocity (cm/y) Change in height during treatment period (cm) Children’s height was measured by Harpenden stadiometer at every visit using a standard protocol
Notes	Treatment compliance was measured by percentage of days child reported to take prescribed dose of study medication as recorded in a dairy. Compliance rate was 73.7% in the budesonide group and 76.2% in the placebo group
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated, randomised schedule
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	Unclear risk	No discontinuations due to asthma or to any clinical or laboratory adverse experiences. Percentage of participants who completed the study was similar in the 3 groups
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