| Methods |
DESIGN: prospective, randomised, double blind, placebo‐controlled CROSSOVER TRIAL (2 week washout period)
RANDOMISATION: method of randomisation not described; ketotifen and placebo syrup of similar consistency and appearance and almost identical in taste |
| Participants |
N = 31 (randomised)
N = 30 (completed) WITHDRAWAL/DROPOUT: 1 patient excluded (non‐compliance)
AGE: 12‐35 months (mean 22,6 months)
SEVERITY: mild or moderate asthma |
| Interventions |
DOSE: 1 mg twice daily
RUN‐IN: 2 weeks
TREATMENT: 12 weeks
ADDITIONAL MEDICATION: beta‐2 agonists, theophylline, burst of prednisone |
| Outcomes |
asthmatic symptomology, concomitant medication |
| Notes |
only data from first period of trial considered in this review |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Described as randomised; no other information available |
| Allocation concealment? |
Unclear risk |
Information not available |
| Blinding?
All outcomes |
Low risk |
Identical presentation of Ketotifen and placebo |
