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

Margaret Frank Guill, R. H. Buckley, W. Rocha, J. P. Kemp, A. T. Sega, L. R. Shirley, D. G. Tinkelman, Z. Shaath-Schwen, K. K. Dietrich, L. J. Wille, T. H. Tsai

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

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) I-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 <30 kg receiving terfenadine suspension, 30 mg twice daily, and those weighing >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.

Original languageEnglish (US)
Pages (from-to)4-9
Number of pages6
JournalThe Journal of Allergy and Clinical Immunology
Volume78
Issue number1 PART 1
DOIs
StatePublished - Jan 1 1986

Fingerprint

Terfenadine
Suspensions
Placebos
Histamine Antagonists
Therapeutics
Sneezing
Drug Evaluation
Urinalysis
Blood Cell Count
Lost to Follow-Up
Pollen
Poaceae
Allergic Rhinitis
Skin Tests
Spores
Nose
Fungi
Safety
Incidence

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children. / Guill, Margaret Frank; Buckley, R. H.; Rocha, W.; Kemp, J. P.; Sega, A. T.; Shirley, L. R.; Tinkelman, D. G.; Shaath-Schwen, Z.; Dietrich, K. K.; Wille, L. J.; Tsai, T. H.

In: The Journal of Allergy and Clinical Immunology, Vol. 78, No. 1 PART 1, 01.01.1986, p. 4-9.

Research output: Contribution to journalArticle

Guill, MF, Buckley, RH, Rocha, W, Kemp, JP, Sega, AT, Shirley, LR, Tinkelman, DG, Shaath-Schwen, Z, Dietrich, KK, Wille, LJ & Tsai, TH 1986, 'Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children', The Journal of Allergy and Clinical Immunology, vol. 78, no. 1 PART 1, pp. 4-9. https://doi.org/10.1016/0091-6749(86)90107-7
Guill, Margaret Frank ; Buckley, R. H. ; Rocha, W. ; Kemp, J. P. ; Sega, A. T. ; Shirley, L. R. ; Tinkelman, D. G. ; Shaath-Schwen, Z. ; Dietrich, K. K. ; Wille, L. J. ; Tsai, T. H. / Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children. In: The Journal of Allergy and Clinical Immunology. 1986 ; Vol. 78, No. 1 PART 1. pp. 4-9.
@article{f18b76cadee64df79f156bee336ed28e,
title = "Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children",
abstract = "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) I-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 <30 kg receiving terfenadine suspension, 30 mg twice daily, and those weighing >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.",
author = "Guill, {Margaret Frank} and Buckley, {R. H.} and W. Rocha and Kemp, {J. P.} and Sega, {A. T.} and Shirley, {L. R.} and Tinkelman, {D. G.} and Z. Shaath-Schwen and Dietrich, {K. K.} and Wille, {L. J.} and Tsai, {T. H.}",
year = "1986",
month = "1",
day = "1",
doi = "10.1016/0091-6749(86)90107-7",
language = "English (US)",
volume = "78",
pages = "4--9",
journal = "Journal of Allergy and Clinical Immunology",
issn = "0091-6749",
publisher = "Mosby Inc.",
number = "1 PART 1",

}

TY - JOUR

T1 - Multicenter, double-blind, placebo-controlled trial of terfenadine suspension in the treatment of fall-allergic rhinitis in children

AU - Guill, Margaret Frank

AU - Buckley, R. H.

AU - Rocha, W.

AU - Kemp, J. P.

AU - Sega, A. T.

AU - Shirley, L. R.

AU - Tinkelman, D. G.

AU - Shaath-Schwen, Z.

AU - Dietrich, K. K.

AU - Wille, L. J.

AU - Tsai, T. H.

PY - 1986/1/1

Y1 - 1986/1/1

N2 - 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) I-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 <30 kg receiving terfenadine suspension, 30 mg twice daily, and those weighing >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.

AB - 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) I-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 <30 kg receiving terfenadine suspension, 30 mg twice daily, and those weighing >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.

UR - http://www.scopus.com/inward/record.url?scp=0022586501&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0022586501&partnerID=8YFLogxK

U2 - 10.1016/0091-6749(86)90107-7

DO - 10.1016/0091-6749(86)90107-7

M3 - Article

VL - 78

SP - 4

EP - 9

JO - Journal of Allergy and Clinical Immunology

JF - Journal of Allergy and Clinical Immunology

SN - 0091-6749

IS - 1 PART 1

ER -