EFFICACY AND SAFETY OF LORATADINE PLUS PSEUDOEPHEDRINE IN PATIENTS WITH SEASONAL ALLERGIC RHINITIS AND MILD ASTHMA

Background: Antihistamines have been shown to have a variety of therap eutic effects in asthma. Although nasal obstruction may play an import ant role in modulating lower airway function, no prior trial has used a decongestant in combination with an antihistamine in patients with a llergic rhinitis and concomitant asthma. Objective: We sought to deter mine the efficacy and safety of loratadine (5 mg) plus pseudoephedrine (120 mg) (L/P) twice daily in patients with seasonal allergic rhiniti s and mild asthma. Methods: We conducted a randomized, double-blind, p lacebo-controlled trial of L/P in 193 subjects during the fall allergy season. Nasal and chest symptoms, albuterol use, and peak expiratory pow rates were recorded daily for 6 weeks. Spirometry was measured at baseline and after 1, 2, 4, and 6 weeks of therapy, and health-related quality of life was rated at the beginning and end of the study. Resu lts: Total rhinitis and asthma symptom severity scores were significan tly reduced in patients receiving active therapy compared with those r eceiving placebo throughout the 6-week study. Peak expiratory flow rat es improved significantly in patients treated with L/P during weeks 2 through 6 (peak effect [mean +/- SEM]: L/P, 26.23 +/- 4.64 L/min vs pl acebo, 8.52 +/- 3.53 L/min, p = 0.002) as did FEV1 (peak effect [mean +/- SEM]: L/P, 170 +/- 53 ml vs placebo, 20 +/- 40 ml, p = 0.01) at al l clinic visits. In addition, select measures of asthma-specific quali ty of life improved significantly relative to placebo. Conclusions: L/ P significantly improved nasal and asthma symptoms, pulmonary function , and quality of life in patients with seasonal allergic rhinitis and concomitant mild asthma.