دورية أكاديمية

Fexofenadine HCl 60 mg/ pseudoephedrine HCl 120 mg has a 60-minute onset of action in the treatment of seasonal allergic rhinitis symptoms, as assessed in an allergen exposure unit.

التفاصيل البيبلوغرافية
العنوان: Fexofenadine HCl 60 mg/ pseudoephedrine HCl 120 mg has a 60-minute onset of action in the treatment of seasonal allergic rhinitis symptoms, as assessed in an allergen exposure unit.
المؤلفون: Berkowitz RB; RxResearch, Woodstock, Georgia, USA., McCafferty F, Lutz C, Bazelmans D, Godfrey P, Meeves S, Liao Y, Georges G
المصدر: Allergy and asthma proceedings [Allergy Asthma Proc] 2004 Sep-Oct; Vol. 25 (5), pp. 335-43.
نوع المنشور: Clinical Trial; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: OceanSide Publications Country of Publication: United States NLM ID: 9603640 Publication Model: Print Cited Medium: Print ISSN: 1088-5412 (Print) Linking ISSN: 10885412 NLM ISO Abbreviation: Allergy Asthma Proc Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Providence, R.I. : OceanSide Publications, c1996-
مواضيع طبية MeSH: Bronchodilator Agents/*pharmacology , Ephedrine/*pharmacology , Histamine H1 Antagonists/*pharmacology , Rhinitis, Allergic, Seasonal/*drug therapy , Terfenadine/*analogs & derivatives , Terfenadine/*pharmacology, Adolescent ; Adult ; Allergens/immunology ; Ambrosia/immunology ; Bronchial Provocation Tests ; Bronchodilator Agents/adverse effects ; Bronchodilator Agents/therapeutic use ; Child ; Double-Blind Method ; Drug Combinations ; Ephedrine/adverse effects ; Ephedrine/therapeutic use ; Female ; Histamine H1 Antagonists/adverse effects ; Histamine H1 Antagonists/therapeutic use ; Humans ; Male ; Middle Aged ; Pollen/immunology ; Rhinitis, Allergic, Seasonal/etiology ; Terfenadine/adverse effects ; Terfenadine/therapeutic use ; Time Factors ; Treatment Outcome
مستخلص: Although antihistamine-decongestant combinations are frequently used for allergic rhinitis, published data about the onset of action of these combination agents are limited. This randomized, double-blind, placebo-controlled, parallel-group study investigated the onset of action, efficacy, and safety of fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg or placebo in patients with moderate-to-severe seasonal allergic rhinitis in an allergen exposure unit. Assessments included major symptom complex (MSC) score (sum of sneezing, itchy nose, runny nose, watery eyes, itchy eyes, itchy ears/throat, and stuffy nose), and total symptom complex (TSC) score (MSC symptoms plus nose blows, sniffles, postnasal drip, and cough). Onset of action was defined as the first time that two consecutive, statistically significant absolute changes in MSC scores from baseline were achieved for study drug relative to placebo. The onset of action for the combination was 60 minutes (mean absolute MSC change from baseline: -6.9 +/- 0.3 for the combination compared with -5.9 +/- 0.3 for placebo from a baseline of 17.0 and 16.8, respectively; p < 0.05) for the modified intention-to-treat population (n = 486). Reductions in absolute MSC scores were significantly greater with the combination than placebo at all subsequent time points (p < 0.01). The combination resulted in significantly greater reductions compared with placebo for percent MSC, absolute TSC, and percent TSC scores at 60 minutes postdose (all p < 0.05) and throughout the study (all p < 0.05). The incidence of adverse events was 1.6 and 3.3% for the combination and placebo, respectively. In conclusion, fexofenadine HCl 60 mg/pseudoephedrine HCl 120 mg is effective in the treatment of patients with moderate-to-severe seasonal AR, with an onset of action of 60 minutes and a good safety profile.
المشرفين على المادة: 0 (Allergens)
0 (Bronchodilator Agents)
0 (Drug Combinations)
0 (Histamine H1 Antagonists)
7BA5G9Y06Q (Terfenadine)
E6582LOH6V (fexofenadine)
GN83C131XS (Ephedrine)
تواريخ الأحداث: Date Created: 20041218 Date Completed: 20050222 Latest Revision: 20161020
رمز التحديث: 20240628
PMID: 15603207
قاعدة البيانات: MEDLINE