| Methods |
DESIGN: prospective, randomised, double blind, placebo‐controlled trial
RANDOMISATION: method of randomisation not described |
| Participants |
N = 214 (randomised)
N = 189 (completed) WITHDRAWAL/DROPOUT: 12 in Ketotifen group (deterioration of symptoms or adverse effects: 4, reasons unrelated to treatment, i.e. poor compliance, concurrent illness: 8), 13 in placebo group (deterioration of symptoms or adverse effects: 3, reasons unrelated to treatment: 10)
AGE: 2‐6 years (mean 54 months)
SEVERITY: symptoms of chronic recurrent cough and/or wheeze and evidence of airway hyperreactivity (symptoms present for at least 4 weeks); alternatively, history of 3 or more episodes of at least 5 days of cough and/or wheeze over a 2 month period or 5 or more episodes over a 3 month period;exclusion of patients taking inhaled or systemic steroids at study entry |
| Interventions |
DOSE: 1 mg/d for 1 week followed by 2 mg/d
RUN‐IN: 4 weeks
TREATMENT: 12 weeks
ADDITIONAL MEDICATION: beta‐2 agonists, xanthines, steroids |
| Outcomes |
parents' opinion, day and night cough, day and night wheeze, exacerbations, housebound days, medication score, average behavior score |
| 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 |
