Onset of action, efficacy, and safety of a single dose of fexofenadine hydrochloride for ragweed allergy using an environmental exposure unit

被引:76
作者
Day, JH
Briscoe, MP
Welsh, A
Smith, JN
Clark, A
Ellis, AK
Mason, J
机构
[1] Kingston Gen Hosp, Div Allergy, Kingston, ON K7L 2V7, Canada
[2] Nordic Merrell Dow Res, Laval, PQ, Canada
关键词
D O I
10.1016/S1081-1206(10)63062-1
中图分类号
R392 [医学免疫学];
学科分类号
100102 ;
摘要
Background: Fexofenadine hydrochloride is the active acid metabolite of terfenadine. Fexofenadine's anti-allergic properties require confirmation in a clinical setting. Objective: The purpose of this study was to characterize the time to onset of clinically important relief of symptoms of allergic rhinitis in subjects taking single doses of either 60 mg or 120 mg fexofenadine HCl, or placebo, after exposure to ragweed pollen in a controlled environment. Other objectives were to assess the efficacy and safety of single doses of fexofenadine HCl. Methods: One hundred forty-six ragweed-sensitive subjects were primed in the off-season with ragweed pollen in the environmental exposure unit. One hundred thirty-six subjects who adequately responded to priming entered a single-dose placebo phase. Placebo-responders were disqualified from the study, leaving 99 subjects with adequate symptoms to be randomized and given a single dose of either fexofenadine HCl 120 mg (33), 60 mg (33) or placebo (33), after 60 minutes of allergen exposure. Exposure continued over five hours and subjects recorded symptoms every 20 minutes. This study was of a randomized, placebo-controlled, double-blind, parallel design. Results: Median time to onset for relaxed criteria clinically important relief was 60 minutes for both fexofenadine treatment groups, and 100 minutes for placebo (P = .018). The proportion with relief was 82% at 60 mg, 85% at 120 mg, and 64% for placebo. Treated groups had reductions in symptom scores double that of placebo. Conclusions: Fexofenadine is safe and efficacious at single doses of 60 mg and 120 mg. Average time to onset was 60 minutes using controlled pollen exposure in an environmental exposure unit.
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页码:533 / 540
页数:8
相关论文
共 10 条
  • [1] BERSTEIN D, 1996, J ALLERGY CLIN IMMUN, V97, P435
  • [2] DAY J H, 1991, Clinical and Investigative Medicine, V14, pA5
  • [3] A randomized, double-blind, placebo-controlled, controlled antigen delivery study of the onset of action of aerosolized triamcinolone acetonide nasal spray in subjects with ragweed-induced allergic rhinitis
    Day, JH
    Buckeridge, DL
    Clark, RH
    Briscoe, MP
    Phillips, R
    [J]. JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY, 1996, 97 (05) : 1050 - 1057
  • [4] DAY JH, 1988, N ENGL REG ALLERGY P, V9, P298
  • [5] Efficacy of immunotherapy to ragweed antigen tested by controlled antigen exposure
    Donovan, JP
    Buckeridge, DL
    Briscoe, MP
    Clark, RH
    Day, JH
    [J]. ANNALS OF ALLERGY ASTHMA & IMMUNOLOGY, 1996, 77 (01) : 74 - 80
  • [6] CHANGES IN THE PHARMACOKINETICS AND ELECTROCARDIOGRAPHIC PHARMACODYNAMICS OF TERFENADINE WITH CONCOMITANT ADMINISTRATION OF ERYTHROMYCIN
    HONIG, PK
    WOOSLEY, RL
    ZAMANI, K
    CONNER, DP
    CANTILENA, LR
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 1992, 52 (03) : 231 - 238
  • [7] TERFENADINE-KETOCONAZOLE INTERACTION - PHARMACOKINETIC AND ELECTROCARDIOGRAPHIC CONSEQUENCES
    HONIG, PK
    WORTHAM, DC
    ZAMANI, K
    CONNER, DP
    MULLIN, JC
    CANTILENA, LR
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1993, 269 (12): : 1513 - 1518
  • [8] COMPARATIVE TRIAL OF 2 NON-SEDATIVE H-1 ANTIHISTAMINES, TERFENADINE AND ASTEMIZOLE, FOR HAY-FEVER
    HOWARTH, PH
    HOLGATE, ST
    [J]. THORAX, 1984, 39 (09) : 668 - 672
  • [9] OEI HD, 1988, ANN ALLERGY, V61, P436
  • [10] Tinkeliman D., 1996, Journal of Allergy and Clinical Immunology, V97, P435, DOI 10.1016/S0091-6749(96)81227-9