BACKGROUND:Fexofenadine HCl (Allegra, Telfast) is approved in the US for twice-daily dosing for treatment of seasonal allergic rhinitis. OBJECTIVE: To determine the effect of once-daily fexofenadine HCl on patient-reported quality of life and impairment at work, in the classroom, and in daily activities due to seasonal allergic rhinitis symptoms. METHODS: This placebo-controlled, double-blind, randomized study included patients aged 12 to 65 years with moderate-to-severe seasonal allergic rhinitis symptoms. Outcomes were assessed using self-administered questionnaires at baseline, week 1, and week 2. Outcome measures included change from baseline in: overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score; individual RQLQ domain scores; work, classroom, and daily activity impairment measured using the Work Productivity and Activity Impairment (WPAI) instrument; and ratings in 3 generic health domains from the SF-36 Health Survey. RESULTS: Intent to treat efficacy analyses included 845 patients from 40 sites. Patients receiving either 120 or 180 mg QD fexofenadine HCl reported significantly greater improvement (P < or = .006) in overall RQLQ score than patients receiving placebo. Similarly, both fexofenadine treatment groups reported significantly greater reductions in overall work impairment and daily activity impairment compared with the placebo group (P < or = .004). There was a trend for improvement in classroom impairment with fexofenadine treatment, although differences from placebo were not statistically significant. Generic health measures demonstrated fexofenadine HCl treatment had a positive effect on general health. CONCLUSION: Once-daily fexofenadine HCl, 120 or 180 mg, significantly improved patient-reported quality of life and reduced performance impairment in work and daily activities due to seasonal allergic rhinitis symptoms compared with placebo.
RCT Entities:
BACKGROUND:Fexofenadine HCl (Allegra, Telfast) is approved in the US for twice-daily dosing for treatment of seasonal allergic rhinitis. OBJECTIVE: To determine the effect of once-daily fexofenadine HCl on patient-reported quality of life and impairment at work, in the classroom, and in daily activities due to seasonal allergic rhinitis symptoms. METHODS: This placebo-controlled, double-blind, randomized study included patients aged 12 to 65 years with moderate-to-severe seasonal allergic rhinitis symptoms. Outcomes were assessed using self-administered questionnaires at baseline, week 1, and week 2. Outcome measures included change from baseline in: overall Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score; individual RQLQ domain scores; work, classroom, and daily activity impairment measured using the Work Productivity and Activity Impairment (WPAI) instrument; and ratings in 3 generic health domains from the SF-36 Health Survey. RESULTS: Intent to treat efficacy analyses included 845 patients from 40 sites. Patients receiving either 120 or 180 mg QD fexofenadine HCl reported significantly greater improvement (P < or = .006) in overall RQLQ score than patients receiving placebo. Similarly, both fexofenadine treatment groups reported significantly greater reductions in overall work impairment and daily activity impairment compared with the placebo group (P < or = .004). There was a trend for improvement in classroom impairment with fexofenadine treatment, although differences from placebo were not statistically significant. Generic health measures demonstrated fexofenadine HCl treatment had a positive effect on general health. CONCLUSION: Once-daily fexofenadine HCl, 120 or 180 mg, significantly improved patient-reported quality of life and reduced performance impairment in work and daily activities due to seasonal allergic rhinitis symptoms compared with placebo.
Authors: Eef L Theunissen; Marinus J P G van Kroonenburgh; Jeroen A van Deursen; Ciska Blom-Coenjaerts; Johannes G Ramaekers Journal: Psychopharmacology (Berl) Date: 2006-05-23 Impact factor: 4.530