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Comparative study of cetirizine and terfenadine versus placebo in the symptomatic management of seasonal allergic rhinitis.
Ann Allergy Asthma Immunol. 1996 May; 76(5):448-54.AA

Abstract

BACKGROUND

Cetirizine is a new antihistamine with greater selectivity for the histamine H1 receptor and a low rate of hepatic metabolism. Cetirizine once daily is effective in the symptomatic treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria.

OBJECTIVE

The efficacy and safety of cetirizine 10 mg qd, terfenadine 60 mg bid, and placebo were compared in patients with seasonal allergic rhinitis.

METHODS

A multicenter, prospective, double-blind, randomized, parallel study was conducted for 2 weeks during the ragweed pollen season in patients with documented allergic rhinitis. Total symptom complex and total symptom complex plus nasal congestion scores, global efficacy, overall satisfaction, and adverse events were assessed at baseline and after 1 and 2 weeks of treatment.

RESULTS

Of the 311 patients randomized to treatment, 283 completed the study. Cetirizine produced a marked improvement in symptoms scores compared with placebo after 1 week of therapy (P = .001). By the end of week 1, total symptom complex scores were improved by 37% with cetirizine compared with 29% for terfenadine, and 23% for placebo. An overall treatment effect was evident at week 1 (P = .0019), with marked differences between cetirizine and both placebo (P = .0004) and terfenadine (P = .0464) but not between terfenadine and placebo (P = .1215). A more marked treatment effect was evident during the first week of the study; this appeared to be related to spontaneous resolution of symptoms, since mean pollen counts derived for each patient declined significantly each week of the study. Therapy was generally well tolerated. Headache was the most common side effect in each group. Four patients on cetirizine, one on terfenadine, and two on placebo withdrew because of side effects. Somnolence was reported in 12 patients on cetirizine (P < .05), 2 on terfenadine, and 3 on placebo.

CONCLUSION

Cetirizine produced a greater improvement in symptoms of seasonal allergic rhinitis than terfenadine or placebo.

Authors+Show Affiliations

Division of Allergy and Immunology, University of South Florida College of Medicine, Tampa, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

8630719

Citation

Lockey, R F., et al. "Comparative Study of Cetirizine and Terfenadine Versus Placebo in the Symptomatic Management of Seasonal Allergic Rhinitis." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 76, no. 5, 1996, pp. 448-54.
Lockey RF, Widlitz MD, Mitchell DQ, et al. Comparative study of cetirizine and terfenadine versus placebo in the symptomatic management of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1996;76(5):448-54.
Lockey, R. F., Widlitz, M. D., Mitchell, D. Q., Lumry, W., Dockhorn, R., Woehler, T., & Grossman, J. (1996). Comparative study of cetirizine and terfenadine versus placebo in the symptomatic management of seasonal allergic rhinitis. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 76(5), 448-54.
Lockey RF, et al. Comparative Study of Cetirizine and Terfenadine Versus Placebo in the Symptomatic Management of Seasonal Allergic Rhinitis. Ann Allergy Asthma Immunol. 1996;76(5):448-54. PubMed PMID: 8630719.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative study of cetirizine and terfenadine versus placebo in the symptomatic management of seasonal allergic rhinitis. AU - Lockey,R F, AU - Widlitz,M D, AU - Mitchell,D Q, AU - Lumry,W, AU - Dockhorn,R, AU - Woehler,T, AU - Grossman,J, PY - 1996/5/1/pubmed PY - 1996/5/1/medline PY - 1996/5/1/entrez SP - 448 EP - 54 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann Allergy Asthma Immunol VL - 76 IS - 5 N2 - BACKGROUND: Cetirizine is a new antihistamine with greater selectivity for the histamine H1 receptor and a low rate of hepatic metabolism. Cetirizine once daily is effective in the symptomatic treatment of seasonal and perennial allergic rhinitis and chronic idiopathic urticaria. OBJECTIVE: The efficacy and safety of cetirizine 10 mg qd, terfenadine 60 mg bid, and placebo were compared in patients with seasonal allergic rhinitis. METHODS: A multicenter, prospective, double-blind, randomized, parallel study was conducted for 2 weeks during the ragweed pollen season in patients with documented allergic rhinitis. Total symptom complex and total symptom complex plus nasal congestion scores, global efficacy, overall satisfaction, and adverse events were assessed at baseline and after 1 and 2 weeks of treatment. RESULTS: Of the 311 patients randomized to treatment, 283 completed the study. Cetirizine produced a marked improvement in symptoms scores compared with placebo after 1 week of therapy (P = .001). By the end of week 1, total symptom complex scores were improved by 37% with cetirizine compared with 29% for terfenadine, and 23% for placebo. An overall treatment effect was evident at week 1 (P = .0019), with marked differences between cetirizine and both placebo (P = .0004) and terfenadine (P = .0464) but not between terfenadine and placebo (P = .1215). A more marked treatment effect was evident during the first week of the study; this appeared to be related to spontaneous resolution of symptoms, since mean pollen counts derived for each patient declined significantly each week of the study. Therapy was generally well tolerated. Headache was the most common side effect in each group. Four patients on cetirizine, one on terfenadine, and two on placebo withdrew because of side effects. Somnolence was reported in 12 patients on cetirizine (P < .05), 2 on terfenadine, and 3 on placebo. CONCLUSION: Cetirizine produced a greater improvement in symptoms of seasonal allergic rhinitis than terfenadine or placebo. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/8630719/Comparative_study_of_cetirizine_and_terfenadine_versus_placebo_in_the_symptomatic_management_of_seasonal_allergic_rhinitis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1081-1206(10)63462-X DB - PRIME DP - Unbound Medicine ER -