Boulet 2006.

Methods	STUDY DESIGN: Parallel group LOCATION, NUMBER OF CENTRES: Europe and Canada, 64 centres. DURATION OF STUDY: 12 weeks (2 week run‐in on usual dose of ICS, with high dose ICS during a post‐run in baseline period prior to study entry) CONCEALMENT OF ALLOCATION: Adequate COCHRANE QUALITY SCORE: DESCRIBED AS RANDOMISED: Yes DESCRIBED AS DOUBLE BLIND: Yes METHOD OF RANDOMISATION WELL DESCRIBED/APPROPRIATE: Yes (computer generated list) METHOD OF BLINDING WELL DESCRIBED/APPROPRIATE: yes (double dummy) DESCRIPTION OF WITHDRAWALS/DROPOUTS: Yes JADAD SCORE (5‐1): 5 TYPE OF ANALYSIS (AVAILABLE CASE/TREATMENT RECEIVED/ ITT): ITT COMPLIANCE: Not reported CONFOUNDERS: Baseline values showed older, more females, fewer non‐smokers, higher baseline dose of ICS, lower FEV1, and greater reversibility in BUD group
Participants	N SCREENED: 688 N RANDOMISED: 359 N COMPLETED: 320 (PP) and 359 (ITT analysis) M = 148; F = 211 MEDIAN AGE (range): CIC320 39 years (12‐72); BUD320 42 (12‐71) BASELINE DETAILS: FEV1 (% Pred): CIC320 2.60 (81%); BUD320 2.43 (79%) INCLUSION CRITERIA: Aged 12‐75 years; persistent asthma for 6 months ATS definition; FEV1 of 65‐95% depending on ICS pretreatment at baseline of 320‐640 ug BUD and the addition of other controller meds (LABA, LTAs or equivalent). To enter treatment period patients had to also demonstrate improvement in FEV1 during pretreatment period of >= 7% or 150 mls following the increase in their daily ICS dose of 320‐640 ug BUD (or the equivalent) to 1280 mcg BUD. EXCLUSION: Concomitant severe diseases or contraindications to ICS use; abnormal lab tests suggesting disease; Use of systemic steroids within 4 weeks or injectable steroids within 6 weeks of baseline or more than 3 times within last 6 months or had an asthma exacerbation, LRTI or asthma hospitalisation within 4 weeks of baseline. Had other lung disease or COPD, or heavy smokers or ex‐smokers with smoking history >= 10 cigs per day or two pipes per day; suspected noncompliance; drug abuse;or pregnancy.
Interventions	1. Ciclesonide 400 mcg OD 2. Budesonide 400 mcg OD DELIVERY: CIC: HFA‐MDI (no spacer), BUD: Turbohaler in morning TREATMENT PERIOD: 12 weeks RESCUE: Salbutamol MDI CO‐INTERVENTIONS PERMITTED: None % on ICS baseline: not indicated (but it would appear to be all patients)
Outcomes	FEV1; FVC; am PEF; pm PEF; clinic PEF; adverse events; exacerbations; withdrawals
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Low risk	A ‐ Adequate