| Methods |
DESIGN: prospective, randomised, double blind, placebo‐controlled trial
RANDOMISATION: method of randomisation not described |
| Participants |
N = 79 (randomised)
N = 75 (completed) WITHDRAWAL/DROPOUT: 2 in Ketotifen group for "personal reasons", 2 in placebo group due to incomplete data and no success in therapy
AGE: 4‐23 months
SEVERITY: wheezing or cough, diagnosed as asthma |
| Interventions |
DOSE: 0,5 mg twice daily
RUN‐IN: 2 weeks
TREATMENT: 12 weeks
ADDITIONAL MEDICATION: beta‐2 agonists, theophylline |
| Outcomes |
Number of patients with cough, with wheezing with severe asthma, using bronchodilators; side effects and treatment efficacy rated by physicians |
| 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 |
Unclear risk |
Information not available |
