| Methods |
DESIGN: multicenter, prospective, randomised, double blind, placebo‐controlled trial
RANDOMISATION: randomisation by computer generated code; parallel group design with infants stratified by age groups, gender and symptoms; placebo syrup was identical in appearance |
| Participants |
N = 113 (randomised)
N = 97 (completed)
WITHDRAWAL/DROPOUT: 1 (insufficient symptoms to continue treatment), 7 (loss to follow‐up or unwillingness to continue study), 4 adverse events (diarrhoea, vomiting or rush, each 2 in Ketotifen and placebo group), 2 (protocol violation), 2 (treatment failure)
AGE: 6‐36 months (mean 22 months)
SEVERITY: history of cough and/or wheeze for at least 3 months and occurring on at least 50% of the days; exclusion of infants with any serious chronic illness, previous long‐term use of sodium cromoglycate, currently use of theophylline or sodium cromoglycate or use of steroids for more than 5 days in the last 3 months |
| Interventions |
DOSE: 0,5 mg twice a day
RUN‐IN: 4 weeks
TREATMENT: 16 weeks
ADDITIONAL MEDICATION: beta‐2 agonists, antibiotics |
| Outcomes |
treatment efficacy (assessed by investigators and parents) tolerability, beta‐agonist usage |
| Notes |
|
| 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 |
