Lemanske 2004.
Methods | DESIGN: randomised, double‐blind clinical trial | |
Participants | SYMPTOMATIC PARTICIPANTS RANDOMLY ASSIGNED: 205 WITHDRAWALS: not reported AGE: median (years) (range): 4 to 9 years GENDER: N (male %): not reported ASTHMA SEVERITY ASTHMA DURATION: median (months) (range): not reported MEAN (± SD) β2‐AGONIST USE (puffs/d): median (months) (range): not reported DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: not reported ATOPY (% of participants): not reported ELIGIBILITY CRITERIA: not reported EXCLUSION CRITERIA: not reported |
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Interventions | PROTOCOL DURATION
DEVICE: metered‐dose inhaler DOSE OF ICS
CRITERIA FOR WITHDRAWAL FROM STUDY: |
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Outcomes | ANALYSIS: Efficacy was assessed on an intent to‐treat (ITT) basis; between‐group differences in changes from baseline in the primary variable were also evaluated in the per‐protocol population. Primary and secondary spirometry data and diary data were fit with an analysis of co‐variance (ANCOVA) model; results of urine cortisol analysis were summarised with descriptive statistics OUTCOMES GROWTH MEASUREMENT TECHNIQUE: stadiometric height measured and growth velocities calculated PULMONARY FUNCTION TESTS
FUNCTIONAL STATUS
BIOMARKERS
ADVERSE EVENTS: reported WITHDRAWALS: not reported |
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Notes | PUBLICATION: abstract; full paper not found FUNDING: not reported CONFIRMATION OF METHODOLOGY: not received |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The trial was randomised but the randomisation technique was not mentioned |
Allocation concealment (selection bias) | Unclear risk | No details reported |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details reported |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Incomplete reporting of details for judgement |
Selective reporting (reporting bias) | Low risk | Primary and secondary outcomes described |
Other bias | Low risk | No apparent risk of bias noted |