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

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
Interventions PROTOCOL
DURATION
  • Run‐in = not reported

  • Intervention = 48 weeks


DEVICE: metered‐dose inhaler
DOSE OF ICS
  • INTERVENTION: mometasone furoate 100 μg/d

  • CONTROL: mometasone furoate 200 μg/d


CRITERIA FOR WITHDRAWAL FROM STUDY:
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
  • PEFR


FUNCTIONAL STATUS
  • Growth velocity

  • Bone age

  • Bone metabolism

  • Ophthalmic examination

  • Asthma control


BIOMARKERS
  • Plasma and urine cortisol


ADVERSE EVENTS: reported
WITHDRAWALS: not reported
Notes PUBLICATION: abstract; full paper not found
FUNDING: not reported
CONFIRMATION OF METHODOLOGY: not received
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