A double‐blind, placebo‐controlled comparison of sodium cromoglycate and ketotifen in the treatment of childhood asthma

Abstract

We compared three treatments: sodium cromoglycate 5 mg aerosol and placebo syrup (39 patients), placebo aerosol and ketotifen syrup (39 patients), and placebo aerosol and syrup (36 patients). The patients (mean age 11.7 years) had mostly allergic, moderately severe asthma. Treatments 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 sodium cromoglycate over the other treatments. During month 3, sodium cromoglycate was superior to ketotifen for night symptoms, morning tightness, 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.

Suppression of plasma matrix metalloproteinase‐9 following montelukast treatment in childhood asthma

“…The effectiveness of ketotifen has been recently challenged. Even sodium cromoglycate was superior to ketotifen in the control of childhood asthma symptoms, including night symptoms, morning tightness, daytime symptoms, and cough 24 . Thus, not surprisingly, ketotifen is not included in the asthma control regimen of the Global Strategy for Asthma Management and Prevention.…”

Asthma

“…In five DBPC pediatric studies [74,511,545,589,667], the following effects were documented: ∑ Reduction of asthmatic attacks and auscultatory findings of long-term wheezing ∑ Reduction in the number of days of disease ∑ Statistical reduction in the use of other drugs [511,545] ∑ Anti-asthma prevention in 91% of cases after 3 years of therapy [74] The effects in other pediatric studies were controversial [589,667]. In one DBPC study, ketotifen proved less effective than cromolyn, possibly because one dose of syrup 4 ml/day was used on subjects weighing 14-18 kg; no data regarding compliance was noted [127].…”

Alternative strategies in the treatment of bronchial asthma

“…Effects of ketotifen, a first generation H 1 ‐specific receptor antagonist, seemed to be promising because of possible intrinsic anti‐inflammatory properties resulting in reduction of eosinophilic activation and migration, and normalization of β‐receptor expression thus preventing tachyphylaxis [ 130, 131]. Since then, many double‐blind, placebo‐controlled studies estimating clinical efficacy of ketotifen in asthma have been performed [ 131–151]. Overall, ketotifen (1 mg bid) seems to ameliorate asthma severity slightly (especially in children), with improvement of symptoms, rescue medication use and number of exacerbations.…”