Harmanci 2006.

Methods	Randomised, parallel group trial Withdrawals: stated Intention‐to‐treat: all participants accounted for in follow‐up
Participants	N: 51 (treatment: 25 (1 excluded); controls: 26) % females: treatment: 50%; control 73% Mean age: treatment: 3.9; control: 3.8 years Setting: ED Baseline severity: PI score > 6 and mild to moderate exacerbation according to Global Initiative for Asthma Guideline) Inclusion criteria: clinical history of intermittent asthma; using PRN beta2‐agonists Exclusion criteria: Inhaled/parental steroids or LTRA last 1/12; previous severe/life‐threatening asthma attacks; preterm/low birthweight infants; infants of mothers smoking during pregnancy; Hx RDS; BPD/GOR/CF)
Interventions	Treatment Oral montelukast (4 mg) given in addition to usual care Control Exact matching placebo tablet in addition to usual care (see above) Study duration: 240 minutes (hospitalisation if O2 sats < 92%, sustained RR > 50, or PI > 6) Usual care: Nebulised beta2‐agonists at entry, 20 minutes, 40 minutes, 180 minutes; oral steroid at 1 hour if PI remained 4+
Outcomes	PI scores, RR, HR
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"The allocation schedule was also created and concealed at the Faculty of Pharmacy and broken at the end of the study"
Allocation concealment (selection bias)	Unclear risk	See above. No details of how allocation was concealed
Blinding of participants and personnel (performance bias) All outcomes	Low risk	"Monteleukast and placebo tablets were identical in appearance and prepared in the laboratories of the Faculty of Pharmacy"
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	"broken at the end of study" implied that assessors were blinded, but no further details
Incomplete outcome data (attrition bias) All outcomes	Low risk	One patient dropped out due to vomiting after 15 minutes of taking study drug