J. Croce et al., A DOUBLE-BLIND, PLACEBO-CONTROLLED COMPARISON OF SODIUM CROMOGLYCATE AND KETOTIFEN IN THE TREATMENT OF CHILDHOOD ASTHMA, Allergy, 50(6), 1995, pp. 524-527
We compared three treatments: sodium cromoglycate 5 mg aerosol and pla
cebo syrup (39 patients), placebo aerosol and ketotifen syrup (39 pati
ents), and placebo aerosol and syrup (36 patients). The patients (mean
age 11.7 years) had mostly allergic, moderately severe asthma. Treatm
ents were added to current therapy (mostly bronchodilators only) for 3
months. Aerosols were taken four times daily and syrups twice daily.
The following results were significant at a level of 5%. At the final
clinic visit, the changes from baseline in lung function favored sodiu
m cromoglycate over the other treatments. During month 3, sodium cromo
glycate was superior to ketotifen for night symptoms, morning tightnes
s, daytime symptoms, and cough. Bronchodilator use decreased more with
sodium cromoglycate than ketotifen. Patients' and clinicians' overall
opinions of treatment effectiveness favored sodium cromoglycate over
ketotifen and placebo. In these patients, sodium cromoglycate was both
effective and superior to ketotifen.