Doniec 2004.

Methods	DESIGN: randomised, parallel‐group clinical study
Participants	SYMPTOMATIC PARTICIPANTS RANDOMLY ASSIGNED: N = 22 INTERVENTION: ICS (budesonide 200 μg/d): 9 CONTROL: ICS (budesonide 800 μg/d): 11 WITHDRAWALS: reported AGE: mean (years) (range): INTERVENTION: ICS (budesonide 200 μg/d): 11.8 ± 2.0 CONTROL: ICS (budesonide 800 μg/d): 13.2 ± 2.3 GENDER: N (male %): INTERVENTION: ICS (budesonide 200 μg/d): 6 (66.6) CONTROL: ICS (budesonide 800 μg/d): 6 (54.5) ASTHMA SEVERITY: mild asthma ASTHMA DURATION: median (months) (range): not reported MEAN (± SD) β2‐AGONIST USE (puffs/d): not reported DOSE OF ICS AT STUDY ENTRY AND AT RUN‐IN: none (steroid naive) ATOPY (% of participants): not reported ELIGIBILITY CRITERIA Mild asthma diagnosed according to GINA protocol Steroid naive Treated with disodium cromoglycate EXCLUSION CRITERIA: not reported
Interventions	PROTOCOL DURATION Run‐in = not reported Intervention = 12 weeks DEVICE: dry powder inhaler (Pulmicort Turbuhaler) DOSE OF ICS INTERVENTION: budesonide 200 μg/d CONTROL: budesonide 800 μg/d CRITERIA FOR WITHDRAWAL FROM STUDY: reported
Outcomes	ANALYSIS: Student's t test OUTCOMES GROWTH MEASUREMENT TECHNIQUE: not reported PULMONARY FUNCTION TESTS: at start of study and at 12 weeks FEV1; FVC FUNCTIONAL STATUS: not reported BIOMARKERS: at start of study and at 12 weeks Plasma levels of native and cryptic met‐enkephalin ADVERSE EVENTS: not reported WITHDRAWALS: reported
Notes	PUBLICATION: full paper (2004) FUNDING: not reported CONFIRMATION OF METHODOLOGY: not received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information on sequence generation
Allocation concealment (selection bias)	Unclear risk	Insufficient information
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Insufficient information
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	Unclear risk	Insufficient information to assess whether an important risk of bias exists