A multicenter trial of the prophylactic effect of ketotifen, theophylline, and placebo in atopic asthma

D. G. Tinkelman, B. A. Moss, S. C. Bukantz, A. L. Sheffer, J. H. Dobken, S. Chodosh, B. M. Cohen, Richard R Rosenthal, I. Rappaport, C. E. Buckley, E. L. Chusid, A. J. Deutsch, G. A. Settipane, R. B P Burns

Research output: Contribution to journalArticle

Abstract

Three hundred seventy-four patients with asthma were entered into a year-long, double-blind, double-placebo controlled study comparing the prophylactic effect of ketotifen (229 patients), theophylline (73 patients), and placebo (72 patients). The ketotifen group was larger to allow the accumulation of additional long-term safety data. The primary measure of therapeutic effect was a decrease in concomitant medication without a significant increase in symptomatology or a decrement in pulmonary functions. A patient daily diary was used to document symptoms (cough, shortness of breath, and wheeze) and concomitant medications taken during the 2-week baseline and the subsequent 12 monthly periods. After 2 months of study-drug therapy, the ketotifen patients had a greater decrease in both concomitant medication and symptomatology than either of the other groups. This delay in the onset of therapeutic activity has been observed in other studies and is characteristic of this compound. The principal side effect observed with ketotifen is initial sedation, which was found to be self-limiting and of little concern to the patient after the first month.

Original languageEnglish (US)
Pages (from-to)487-497
Number of pages11
JournalThe Journal of Allergy and Clinical Immunology
Volume76
Issue number3
DOIs
StatePublished - 1985

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Ketotifen
Theophylline
Multicenter Studies
Asthma
Placebos
Therapeutic Uses
Cough
Dyspnea
Safety
Drug Therapy
Lung

ASJC Scopus subject areas

  • Immunology
  • Immunology and Allergy

Cite this

Tinkelman, D. G., Moss, B. A., Bukantz, S. C., Sheffer, A. L., Dobken, J. H., Chodosh, S., ... Burns, R. B. P. (1985). A multicenter trial of the prophylactic effect of ketotifen, theophylline, and placebo in atopic asthma. The Journal of Allergy and Clinical Immunology, 76(3), 487-497. https://doi.org/10.1016/0091-6749(85)90732-8

A multicenter trial of the prophylactic effect of ketotifen, theophylline, and placebo in atopic asthma. / Tinkelman, D. G.; Moss, B. A.; Bukantz, S. C.; Sheffer, A. L.; Dobken, J. H.; Chodosh, S.; Cohen, B. M.; Rosenthal, Richard R; Rappaport, I.; Buckley, C. E.; Chusid, E. L.; Deutsch, A. J.; Settipane, G. A.; Burns, R. B P.

In: The Journal of Allergy and Clinical Immunology, Vol. 76, No. 3, 1985, p. 487-497.

Research output: Contribution to journalArticle

Tinkelman, DG, Moss, BA, Bukantz, SC, Sheffer, AL, Dobken, JH, Chodosh, S, Cohen, BM, Rosenthal, RR, Rappaport, I, Buckley, CE, Chusid, EL, Deutsch, AJ, Settipane, GA & Burns, RBP 1985, 'A multicenter trial of the prophylactic effect of ketotifen, theophylline, and placebo in atopic asthma', The Journal of Allergy and Clinical Immunology, vol. 76, no. 3, pp. 487-497. https://doi.org/10.1016/0091-6749(85)90732-8
Tinkelman, D. G. ; Moss, B. A. ; Bukantz, S. C. ; Sheffer, A. L. ; Dobken, J. H. ; Chodosh, S. ; Cohen, B. M. ; Rosenthal, Richard R ; Rappaport, I. ; Buckley, C. E. ; Chusid, E. L. ; Deutsch, A. J. ; Settipane, G. A. ; Burns, R. B P. / A multicenter trial of the prophylactic effect of ketotifen, theophylline, and placebo in atopic asthma. In: The Journal of Allergy and Clinical Immunology. 1985 ; Vol. 76, No. 3. pp. 487-497.
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