Pedersen 2010.
Methods | DESIGN: randomised, double‐blind, placebo‐controlled, parallel‐group clinical study | |
Participants | SYMPTOMATIC PARTICIPANTS RANDOMLY ASSIGNED: N = 465 ANALYSED PARTICIPANTS: N = 465 INTERVENTION: ICS (ciclesonide 40 μg/d): 305 CONTROL: ICS (ciclesonide 80 μg/d): 312 WITHDRAWALS: reported AGE: median (years) (range): INTERVENTION: ICS (ciclesonide 40 μg/d): 8.0 (6‐11) CONTROL: ICS (ciclesonide 80 μg/d): 8.0 (6‐11) GENDER: N (male %): INTERVENTION: ICS (ciclesonide 40 μg/d): 210 (68.9%) CONTROL: ICS (ciclesonide 80 μg/d): 191 (61.2%) ASTHMA SEVERITY: persistent asthma but severity not reported ASTHMA DURATION: median (months) (range): INTERVENTION: ICS (ciclesonide 40 μg/d): 41.4 (6‐127) CONTROL: ICS (ciclesonide 80 μg/d): 41.9 (5‐128) MEAN (± SD) β2‐AGONIST USE (puffs/d): median (months) (range) INTERVENTION: ICS (ciclesonide 40 μg/d): 1.43 (0.00‐7.86) CONTROL: ICS (ciclesonide 80 μg/d): 1.43 (0.00‐7.14) DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: placebo ATOPY (% of participants): not reported ELIGIBILITY CRITERIA
EXCLUSION CRITERIA
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Interventions | PROTOCOL DURATION
DEVICE: metered‐dose inhaler with or without spacer DOSE OF ICS
CRITERIA FOR WITHDRAWAL FROM STUDY: reported |
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Outcomes | ANALYSIS: intent‐to‐treat analysis OUTCOMES: reported at 12 weeks; change in height reported as least squares mean growth rate GROWTH MEASUREMENT TECHNIQUE: At investigational sites where a stadiometer was available, height was also measured at the start and the end of the treatment period, as stadiometry is widely acknowledged as the most reliable means of measuring height and is recommended by the Food and Drug Administration (FDA) for studies assessing growth PULMONARY FUNCTION TESTS: mean change in FEV1 and PEFR reported FUNCTIONAL STATUS
BIOMARKERS
ADVERSE EVENTS: reported WITHDRAWALS: reported |
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Notes | PUBLICATION: full paper (2010) FUNDING: funded by Nycomed CONFIRMATION OF METHODOLOGY: not received Data received from Takeda Global Research & Development Centre (Europe) Ltd |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Using a computer random number generator: ”Patients were then randomised into one of four treatment groups in a 2:2:2:1 ratio (ciclesonide 40 mg: ciclesonide 80 mg: ciclesonide 160 mg: placebo) by means of a computer generated randomisation scheme” |
Allocation concealment (selection bias) | Unclear risk | Insufficient information |
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 |