| Methods |
DESIGN: prospective, randomised, double blind, placebo‐controlled trial
RANDOMISATION: method of randomisation not described; identical placebo tablet or syrup used |
| Participants |
N = 191 (randomised)
N = 138 (completed) WITHDRAWAL/DROPOUT: 43 exclusions (non‐compliance or excessive missing data); 5 drop‐outs in Ketotifen group (sedation: 2, treatment failure: 3), 5 drop‐outs in placebo group (sedation: 1, treatment failure: 4)
AGE: 5 ‐ 17 years (mean 10,1 years)
SEVERITY: chronic asthma symptoms requiring daily medications (beta‐agonists and/or xanthines), having a documented history of extrinsic (atopic) asthma and having demonstrated reversible bronchoconstriction; patients had to show a response to a metered dose of inhaled beta‐agonists; exclusion of patients requiring treatment with steroids or DSCG at trial entry |
| Interventions |
DOSE: 1 mg twice daily
RUN‐IN: 4 weeks
TREATMENT: 26 weeks
ADDITIONAL MEDICATION: beta‐2 agonists; theophylline and steroids allowed during treatment period (indication of lack of asthma control) |
| Outcomes |
average daily doses of theophylline and beta‐agonists, FEV1, FVC, PEFR, diurnal variability in peak flow, asthma symptom score, lung ausculation score, FEF (25‐75), number of patients using theophylline, patient global evaluation, physician's evaluation, intercurrent illness (hospital visits due to asthma or URTI), side effects (rush or urticaria, sedation, weight gain, diarrhoea, nausea, vomiting, increased appetite, abdominal pain) |
| Notes |
authors' comment on excluded patients: "Review of the data of the 43 patients that dropped out because of noncompliance did not reveal any outcome difference between these patients and the fully analyzed patients." |
| 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 |
