title: 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.
abstract: 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.
authors.affiliation: RxResearch, Woodstock, Georgia, USA.
authors.forename: Robert B
authors.initials: RB
authors.lastname: Berkowitz
authors.forename: Frank
authors.initials: F
authors.lastname: McCafferty
authors.forename: Cheryl
authors.initials: C
authors.lastname: Lutz
authors.forename: Donna
authors.initials: D
authors.lastname: Bazelmans
authors.forename: Penny
authors.initials: P
authors.lastname: Godfrey
authors.forename: Suzanne
authors.initials: S
authors.lastname: Meeves
authors.forename: Yuning
authors.initials: Y
authors.lastname: Liao
authors.forename: George
authors.initials: G
authors.lastname: Georges
mesh_terms: D000293:Adolescent; D000328:Adult; D000485:Allergens / Q000276:immunology; D031164:Ambrosia / Q000276:immunology; D001985:Bronchial Provocation Tests; D001993:Bronchodilator Agents / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D002648:Child; D004311:Double-Blind Method; D004338:Drug Combinations; D004809:Ephedrine / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D005260:Female; D006634:Histamine H1 Antagonists / Q000009:adverse effects / Q000494:pharmacology* / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D011058:Pollen / Q000276:immunology; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy* / Q000209:etiology; D016593:Terfenadine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology* / Q000627:therapeutic use; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000485:Allergens; D001993:Bronchodilator Agents; D004338:Drug Combinations; D006634:Histamine H1 Antagonists; D016593:Terfenadine; C093230:fexofenadine; D004809:Ephedrine