| Methods |
DESIGN: prospective, randomised, double blind, placebo‐controlled trial
RANDOMISATION: ketotifen and placebo were supplied by Sandoz Canada Inc. |
| Participants |
N = 66 (randomised)
N = 52 (completed)
WITHDRAWAL/DROPOUT: 10 in ketotifen group (unstable asthma: 6, poor compliance: 2, side effects: 2), 4 in placebo group (unstable asthma: 2, poor compliance: 1, side effects: 1)
AGE: 6‐13 years (mean 8,65 years)
SEVERITY: asthma diagnosis based on a compatible clinical history and the presence of bronchial hyperreactivity; required continuous treatment with an inhaled steroid preparation on < 1 mg/day for at least one month |
| Interventions |
DOSE: 2 mg/day
RUN‐IN: 4 weeks
TREATMENT: 10 weeks
ADDITIONAL MEDICATION: beta‐2 agonists, inhaled steroids |
| Outcomes |
reductions of ICS dosage (defined as average daily dose of ICS used during the follow‐up phase, expressed as a percentage of the average daily dose required during the baseline phase); FEV1, diary card data (symptom score, PEFR diurnal variability, number of doses of inhaled beta‐2 agonists irrespective of dosage or delivery system), logarithm of PC20, adverse effects |
| Notes |
purpose of study was to evaluate a steroid sparing effect of Ketotifen |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
Described as randomised; other information not available |
| Allocation concealment? |
Unclear risk |
Information not available |
| Blinding?
All outcomes |
Unclear risk |
Ketotifen and placebo were supplied by Sandoz Canada Inc. |
