Pedersen 2006.

Methods	STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: 51 centres in Europe, South Africa and Canada. DURATION OF STUDY: 12 weeks (2‐4 week run in on prn SABA) CONCEALMENT OF ALLOCATION: Adequate COCHRANE QUALITY SCORE: A DESCRIBED AS RANDOMISED: Yes DESCRIBED AS DOUBLE BLIND: Yes METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: Computer‐generated randomisation schedule from manufacturer. METHOD OF BLINDING WELL DESCRIBED/APPROPRIATE: Identical inhaler devices. DESCRIPTION OF WITHDRAWALS/DROPOUTS: Not reported JADAD SCORE (5‐1): 4 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT COMPLIANCE: Not assessed CONFOUNDERS: Baseline characteristics comparable.
Participants	N SCREENED: Not reported N RANDOMISED: 728 (N meeting post‐run in criteria and subsequently analysed: 556. Baseline details given for per‐protocol set. CIC: 277; FP279) N COMPLETED: Not reported. M = 331; F = 180 MEDIAN AGE: 10 BASELINE DETAILS: Add‐on therapy prior to baseline: 147; ICS therapy prior to baseline: 332; mean ICS dose: 390mcg/d; FEV1: 1.7L; FEV1 predicted: 80%; am PEF: 257L; Mean FEV1 reversibility: 20% INCLUSION CRITERIA: 6‐15 years; persistent asthma for at least six months (ATS criteria); clinically stable for four weeks prior to study entry; FEV1 predicted: 50‐90% rescue medication only, 80‐100% in patients treated with ICS only; symptom score >1 on 6 of last 10 days of run in; adequate MDI inhaler device technique without spacer. EXCLUSION: History of life‐threatening asthma; two or more inpatient hospitalisations in previous year; >60 days of systemic steroids in past year >400mcg BUD or equivalent/d in 30 days prior to baseline; >8 puffs SABA/d for three consecutive days during run‐in."
Interventions	1. Ciclesonide 100 mcg BID 2. Fluticasone 100 mcg BID DELIVERY: HFA‐MDI TREATMENT PERIOD: 12 weeks (2‐4 week run‐in) RESCUE: Salbutamol CO‐INTERVENTIONS PERMITTED: Not reported. CO‐INTERVENTIONS: Not listed % on ICS (pre‐baseline): 65%
Outcomes	FEV1; clinic PEF; am PEF; pm PEF; symptoms; rescue medication usage; adverse events
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate