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. 2014 Jul 16;2014(7):CD009878. doi: 10.1002/14651858.CD009878.pub2

Brand 2011 b.

Methods DESIGN: randomised, double‐blind, placebo‐controlled, parallel‐group study; in 77 centres
Participants SYMPTOMATIC PARTICIPANTS
RANDOMLY ASSIGNED: N = 377
ANALYSED PARTICIPANTS: N = 377
INTERVENTION: ICS (ciclesonide 40 μg/d): 248
CONTROL: ICS (ciclesonide 160 μg/d): 253
WITHDRAWALS: reported
AGE: mean (years) (range):
INTERVENTION: ICS (ciclesonide 40 μg/d): 4.0 (2.0‐6.0)
CONTROL: ICS (ciclesonide 160 μg/d): 4.0 (2.0‐6.0)
GENDER: N (male %):
INTERVENTION: ICS (ciclesonide 40 μg/d): 164 (66.1)
CONTROL: ICS (ciclesonide 160 μg/d): 137 (54.1)
ASTHMA SEVERITY:
ASTHMA DURATION: median disease duration months (range):
INTERVENTION: ICS (ciclesonide 40 μg/d): 21.6 (3.8‐81.1)
CONTROL: ICS (ciclesonide 160 μg/d): 23.5 (5.9‐77.1)
MEAN (± SD) β2‐AGONIST USE (puffs/d): reported
DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN:
ICS PRETREATMENT n (%):
INTERVENTION: ICS (ciclesonide 40 μg/d): 143 (57.7)
CONTROL: ICS (ciclesonide 160 μg/d): 135 (53.4)
MEAN BASELINE ICS DAILY DOSE mg (SD): beclomethasone dipropionate equivalent
INTERVENTION: ICS (ciclesonide 40 μg/d): 353.0 (141.6)
CONTROL: ICS (ciclesonide 160 μg/d): 335.8 (142.2)
ATOPY (% of participants): reported; N (%) of participants with history of allergies
ASIAN:
INTERVENTION: ICS (ciclesonide 40 μg/d): 16 (36.4)
CONTROL: ICS (ciclesonide 160 μg/d): 21 (46.7)
NON‐ASIAN
INTERVENTION: ICS (ciclesonide 40 μg/d): 106 (52.0)
CONTROL: ICS (ciclesonide 160 μg/d): 122 (58.7)
ELIGIBILITY CRITERIA

  • As above


EXCLUSION CRITERIA

  • As above
Interventions PROTOCOL
DURATION

  • Run‐in = 2 to 4 weeks

  • Intervention = 24 weeks


DEVICE: study medication dispensed via a hydrofluoroalkane metered‐
 dose inhaler, one puff daily in the evening, administered with a spacer (AeroChamber Plus)
DOSE OF ICS

  • INTERVENTION: ciclesonide 40 μg/d

  • CONTROL: ciclesonide 160 μg/d


CRITERIA FOR WITHDRAWAL FROM STUDY: reported
Outcomes As above
Notes As above
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Using a computer random number generator
Allocation concealment (selection bias) Low risk Central allocation (including telephone, web‐based and pharmacy‐controlled randomisation)
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinding of participants and key study personnel ensured
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Blinding of participants and key study personnel ensured
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No missing outcome data
Selective reporting (reporting bias) Low risk Study protocol not available but published reports include all expected outcomes, including those that were prespecified
Other bias Low risk Study apparently free of other sources of bias