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Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children.

Publication ,  Journal Article
Guill, MF; Buckley, RH; Rocha, W; Kemp, JP; Segal, AT; Shirley, LR; Tinkelman, DG; Shaath-Schwen, Z; Dietrich, KK; Wille, LJ
Published in: J Allergy Clin Immunol
July 1986

Children, aged 6 to 12 years, with fall-pollenosis symptoms, were evaluated for their response to a new antihistamine, terfenadine, in a multicenter (six centers) 1-week, double-blind, placebo-controlled trial. All had positive skin tests to grass/weed pollens and/or mold spores prevalent in the fall at each center. Patients were administered placebo or terfenadine as suspension on a randomized basis, with children weighing less than 30 kg receiving terfenadine suspension, 30 mg twice daily, and those weighing greater than 30 kg receiving 60 mg, twice daily. Of the 119 children enrolled, 79 received terfenadine and 40 received placebo. All but two (lost to follow-up) were included for the evaluation of drug safety, whereas 16 were excluded from the efficacy evaluation (11 receiving terfenadine and five receiving placebo) because of protocol noncompliance. Overall, varying degrees of control of symptoms were observed in 85% of the patients in the group taking terfenadine as compared to 60% in the group taking placebo. The symptoms of rhinorrhea, nasal congestion, and sneezing demonstrated the best response. There was no difference between the two groups in adverse events or side effects. Before and after treatment complete blood count, biochemical profile, and urinalysis revealed that there was no change from beginning to end and no difference between the groups. We conclude that terfenadine suspension is a safe, nonsedating antihistamine with an incidence of side effects no different from that of placebo. It is more effective than placebo in controlling symptoms of fall pollenosis in children.

Duke Scholars

Published In

J Allergy Clin Immunol

DOI

ISSN

0091-6749

Publication Date

July 1986

Volume

78

Issue

1 Pt 1

Start / End Page

4 / 9

Location

United States

Related Subject Headings

  • Terfenadine
  • Suspensions
  • Seasons
  • Rhinitis, Allergic, Seasonal
  • Placebos
  • Medical Records
  • Male
  • Humans
  • Histamine H1 Antagonists
  • Female
 

Citation

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Guill, M. F., Buckley, R. H., Rocha, W., Kemp, J. P., Segal, A. T., Shirley, L. R., … Wille, L. J. (1986). Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children. J Allergy Clin Immunol, 78(1 Pt 1), 4–9. https://doi.org/10.1016/0091-6749(86)90107-7
Guill, M. F., R. H. Buckley, W. Rocha, J. P. Kemp, A. T. Segal, L. R. Shirley, D. G. Tinkelman, Z. Shaath-Schwen, K. K. Dietrich, and L. J. Wille. “Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children.J Allergy Clin Immunol 78, no. 1 Pt 1 (July 1986): 4–9. https://doi.org/10.1016/0091-6749(86)90107-7.
Guill MF, Buckley RH, Rocha W, Kemp JP, Segal AT, Shirley LR, et al. Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children. J Allergy Clin Immunol. 1986 Jul;78(1 Pt 1):4–9.
Guill, M. F., et al. “Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children.J Allergy Clin Immunol, vol. 78, no. 1 Pt 1, July 1986, pp. 4–9. Pubmed, doi:10.1016/0091-6749(86)90107-7.
Guill MF, Buckley RH, Rocha W, Kemp JP, Segal AT, Shirley LR, Tinkelman DG, Shaath-Schwen Z, Dietrich KK, Wille LJ. Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children. J Allergy Clin Immunol. 1986 Jul;78(1 Pt 1):4–9.
Journal cover image

Published In

J Allergy Clin Immunol

DOI

ISSN

0091-6749

Publication Date

July 1986

Volume

78

Issue

1 Pt 1

Start / End Page

4 / 9

Location

United States

Related Subject Headings

  • Terfenadine
  • Suspensions
  • Seasons
  • Rhinitis, Allergic, Seasonal
  • Placebos
  • Medical Records
  • Male
  • Humans
  • Histamine H1 Antagonists
  • Female