Methods	Parallel-group, multicentre study (9 centres). Three groups of which 2 are considered in this review Jadad quality score = 5
Participants	Asthmatic children % ELIGIBLE OF SCREENED POPULATION: Not reported % RUN-IN PARTICIPANTS RANDOMISED: Not reported RANDOMISED: 120 (BDP400 + Sal: 60; BDP800: 60) WITHDRAWALS: BDP400 + Sal: 5; BDP800: 6 AGE mean: 11.1 years GENDER (% male): 63 SEVERITY: Mild BASELINE % PREDICTED FEV1: 87.5 BASELINE DOSE OF ICS: 497 mcg ASTHMA DURATION means: 8.5 years ATOPY (%): 90 ELIGIBILITY CRITERIA: FEV1 between 55% and 90% predicted or a FEV1/FVC ratio of 50% to 75%; >= 10% improvement in FEV1 after inhalation of salbutamol; airway hyper-responsiveness to methacholine (PD20); ability to reproduce lung function test; history of stable asthma for >= 1 month without exacerbation or respiratory tract infection; use of inhaled steroids between 200 and 800 mg/day for at least 3 months prior to the beginning of the study EXCLUSION CRITERIA: Operations for congenital heart disease, oesophageal atresia, congenital or acquired anatomical malformation of the lungs or airways, dyskinetic cilia syndrome bronchiectasis; bronchopulmonary dysplasia; diabetes; renal disease; other serious conditions which may influence the possibility of continuation of the study; were using oral corticosteroids continuously or inhaled corticosteroids at a dose of more than 800 mcg daily; were using B-blocking agents or had used cromoglycate or nedocromil sodium within the previous 2 weeks; were allergic to B-agonists; were pregnant or lactating, or females of childbearing age who in the opinion of the supervising physician were not taking adequate contraceptive precautions; an ongoing desensitisation programme; inability to follow therapy instructions, inability to inhale medications adequately or inability to use peak flow meter. During study: non-compliance with respect to study medication, completing the diary cards, clinic visits; withdrawal at own or investigators discretion; total number of course of oral corticosteroids more than allowed in study CRITERIA FOR RANDOMISATION DURING RUN-IN: No additional criteria
Interventions	LABA + ICS versus INCREASED dose ICS OUTCOMES: Reported at 6, 12, 18, 24, 30, 36, 42, 48 and 54 RUN-IN PERIOD: 6 weeks DOSE OF ICS DURING RUN-IN: BDP 200 bid DOSE OPTIMISATION PERIOD: None INTERVENTION PERIOD: 54 weeks TEST GROUP: (Salm50 + BDP200) salmeterol 50 mcg bid + beclomethasone dipropionate 200 mcg bid CONTROL GROUP: (BDP400 + placebo) beclomethasone dipropionate 400 mcg/day + placebo DEVICE: Rotadisks in combination with a diskhaler NUMBER OF DEVICES: 2 COMPLIANCE: Not reported CO-TREATMENT: prn SABA
Outcomes	PULMONARY FUNCTION TEST: FEV1; am PEF; pm PEF; FVC SYMPTOM SCORES: Asthma symptoms like wheezing, dyspnoea, exercise induced asthma and cough were scored in the morning and evening using a scale from 1 to 3; % children reporting no symptoms FUNCTIONAL STATUS: Rescue medication use; exacerbation (requiring systemic steroids); height, body weight, heart rate, systolic and diastolic blood pressure were measured INFLAMMATORY MARKERS: Total IgE ADVERSE EFFECTS: Reported WITHDRAWALS: Reported *Primary outcome: airway calibre measured as FEV1 and airway responsiveness to methacholine
Notes	Full-text publication Funded by Glaxo Wellcome Confirmation of methodology and data obtained up to 24 weeks User-defined number: 400
Risk of bias
Item	Authors’ judgement	Description
Adequate sequence generation?	Yes	Computer-generated random numbers
Allocation concealment?	Yes	Telephone notification of assignment by co-ordinating centre
Blinding? All outcomes	Yes	Double-blind; identical placebo used
Incomplete outcome data addressed? All outcomes	Unclear	Not clear how population for primary outcome Incomplete diary card data not included in analysis: “Where patients failed to complete their daily record cards for more than 7 d in any 14-d period such assessments were not included in the analysis. Otherwise, when there were missing days in the record, pro rata adjustment was made to give a 2-wk assessment.”
Free of selective reporting?	Unclear	OCS-treated exacerbation data available