Abstract
A double-blind placebo controlled cross-over trial was carried out to assess the efficacy of ketotifen in pre-school asthmatics. The trial period consisted of a 1 month run-in and two 6 month treatment periods, with ketotifen 1 mg b.d. or placebo, separated by a 1 month wash-out. 47 children with moderate to severe asthma completed the study. There were 29 boys and 18 girls age ranged from 1 yr 10 months to 5 yrs 11 months (mean 4 yr ∓ 1 yr 3 months). In addition to the study treatment, patients were managed conventionally with beta agonists, theophylline, cromoglycate, inhaled oral steroids. Throughout the study attempts were made to reduce medications to the minimum level compatible with good symptom control. Patients were seen monthly (by BGL) and parents completed a diary card between visits. Benefit was assessed by comparing symptoms of asthma and rhinitis, concomitant medication, and parental and physician preference for the two treatment phases. A preliminary analysis of the data suggests that there was an order effect with symptom control improving and concomitant medication increasing throughout the study period. When active and placebo treatments were compared there was little difference with respect to symptom control, or level of concomitant medication. There was no clear preference expressed for active or placebo therapy. Ketotifen was well tolerated and was associated with increased weight gain.
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Loftus, B., Price, J. KETOTIFEN IN THE MANAGEMENT OF PRE-SCHOOL ASTHMA. Pediatr Res 19, 1099 (1985). https://doi.org/10.1203/00006450-198510000-00178
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DOI: https://doi.org/10.1203/00006450-198510000-00178