Juniper 1991.

Methods	Study design: randomised controlled trial, double‐blind, parallel group Total duration of study: 3 months 'Run‐in' period: no run‐in (this is a follow‐up extension to a previous study) Number of study centres and locations: Firestone Regional Chest and Allergy Clinic at St Joseph's Hospital and the McMaster University Medical Centre in Hamilton, Canada Study setting: secondary care (asthma clinic) Withdrawals: All 28 participants completed the study Date of study: not reported
Participants	N: 28. A subgroup of 14 participants were relevant to this review. Mean age: not reported. Mean age in parent study was ˜ 42 years (Juniper 1990). Age range: not reported Gender: not reported Severity of condition: controlled on step 2 (mild to moderate: approximately half of participants were 'steroid dependent') Baseline lung function: Individual participant data were reported. At entry to initial study, all participants had airway hyper‐responsiveness to methacholine (PC20 < 8.0 mg/mL) and symptomatic asthma. Smoking history: not reported Inclusion criteria and exclusion criteria: successful completion of previous study Details of criteria for step‐down treatment: not reported
Interventions	Intervention: a halving of the budesonide dose in steroid‐dependent participants (n = 6) Comparison: no change in budesonide dose among steroid‐dependent participants (n = 8) Concomitant medications: Bronchodilator medication was permitted (long‐acting vs short‐acting not specified). Excluded medications: not reported
Outcomes	Primary outcomes: airway responsiveness to methacholine (measured with a standardised tidal breathing protocol); clinical asthma severity (i.e. asthma control assessed via asthma severity questionnaire). The questionnaire comprised 6 items: awakened at night by symptoms; awakened in the morning by symptoms; limitation of normal daily activities; sputum; use of bronchodilator more than 4 times per day; FEV1 prebronchodilator < 70% predicted (One point was scored for each of the first 5 items that had been positive on ≥ 1 day during the previous week; 1 point was scored for reduced spirometry; therefore, the maximum asthma severity score (i.e. worst control) was 6). Secondary outcomes: bronchodilator use; allergen exposure score; upper respiratory tract infection score
Notes	Funding for trial: Funding was not reported. Notable conflicts of interest of trial authors: Conflicts of interest were not reported.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information provided
Allocation concealment (selection bias)	Unclear risk	Insufficient information provided
Blinding of participants and personnel (performance bias) All outcomes	Low risk	The study was reported as double‐blind.
Blinding of outcome assessment (detection bias) All outcomes	Low risk	The study was reported as double‐blind.
Incomplete outcome data (attrition bias) All outcomes	Low risk	All 28 randomised participants completed the study, and it appears that data were reported for all 28 participants.
Selective reporting (reporting bias)	High risk	Study authors state, "During analysis, it was found that all the outcomes in the two reduction groups were very similar, and also, the outcomes in the two groups in whom steroids were not reduced were very similar. Therefore, for simplicity, the data have been combined and are presented as two groups, reduced and maintained". No protocol was available; no prespecified analysis plan was prepared. Group data were combined as described above.
Other bias	Low risk	None identified