Teper 2004.

Methods	DESIGN: randomised, double‐blind, placebo‐controlled clinical study.
Participants	SYMPTOMATIC PARTICIPANTS RANDOMLY ASSIGNED: N = 20 INTERVENTION: ICS (fluticasone 100 μg/d): 10 CONTROL: ICS (fluticasone 250 μg/d): 10 WITHDRAWALS: reported AGE: months ± SD: INTERVENTION: ICS at specific dose: 13.1 ± 5.2 CONTROL: ICS (fluticasone 250 μg/d): 14.2 ± 5.7 GENDER: N (male %): INTERVENTION: ICS (fluticasone 100 μg/d): 6 (60%) CONTROL: ICS (fluticasone 250 μg/d): 7 (70%) ASTHMA SEVERITY: recurrent wheezing ASTHMA DURATION (mean years ± SD): not reported MEAN (± SD) β2‐AGONIST USE (puffs/d): not reported DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: not reported ATOPY (% of participants): not reported ELIGIBILITY CRITERIA Age younger than 2 years Asthma symptoms (defined as 3 or more episodes of wheeze, with clinical improvement after bronchodilators, as assessed by physician) Family history of asthma or any other clinical finding indicating atopy EXCLUSION CRITERIA Children with history of severe respiratory infection, cystic fibrosis, aspirative pathology, pulmonary or airways anomalies, bronchopulmonary dysplasia and congenital heart disease, or who previously received ICS or sodium cromoglycate
Interventions	PROTOCOL DURATION Run‐in = not reported Intervention = 24 weeks DEVICE: metered‐dose inhaler with aerochamber DOSE OF ICS INTERVENTION: fluticasone 100 μg/d CONTROL: fluticasone 250 μg/d CRITERIA FOR WITHDRAWAL FROM STUDY: reported
Outcomes	ANALYSIS: not reported OUTCOMES: reported at 24 weeks; change in height reported as standard deviation score GROWTH MEASUREMENT TECHNIQUE: Participant's recumbent length was determined by means of a calibrated stadiometer. Three consecutive measurements were taken to obtain the mean value. Height was expressed as standard deviation score (SDS) for chronological age, according to Tanner and Whitehouse PULMONARY FUNCTION TESTS: not reported FUNCTIONAL STATUS Number of wheezing episodes Number of days on albuterol BIOMARKERS Serum insulin‐like growth factor binding protein 3 Serum cortisol Serum osteocalcin Serum bone alkaline phosphates fraction ADVERSE EVENTS: not reported WITHDRAWALS: reported
Notes	PUBLICATION: full paper (2005) FUNDING: not reported CONFIRMATION OF METHODOLOGY: not received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Using a computer random number generator: ”Each child was then provided with a numbered,blinded metered‐dose aerosol inhaler containing FP (50 or 125 μg per actuation) or placebo, depending on their study group”
Allocation concealment (selection bias)	Low risk	Sequentially numbered drug containers of identical appearance
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