Efficacy and safety of loratadine plus pseudoephedrine in patients with seasonal allergic rhinitis and mild asthma

• Published in: Journal of allergy and clinical immunology 1997-12, Vol.100 (6), p.781-788
• Main Authors: Corren, Jonathan, Harris, Alan G., Aaronson, Donald, Beaucher, Wilfred, Berkowitz, Robert, Bronsky, Edwin, Chen, Rongdean, Chervinsky, Paul, Cohen, Robert, Fourre, Jon, Grossman, Jay, Meltzer, Eli, Pedinoff, Andrew, Stricker, Wesley, Wanderer, Allen
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; albuterol; Albuterol - therapeutic use; asthma; Asthma - drug therapy; Asthma - physiopathology; Biological and medical sciences; Blood. Blood coagulation. Reticuloendothelial system; Child; Double-Blind Method; Drug Therapy, Combination; Ephedrine - adverse effects; Ephedrine - therapeutic use; Female; Humans; Loratadine; Loratadine - adverse effects; Loratadine - therapeutic use; Male; Medical sciences; Middle Aged; nasal obstruction; peak expiratory flow rate; Pharmacology. Drug treatments; pseudoephedrine; Quality of Life; Respiratory Function Tests; rhinitis; Rhinitis, Allergic, Seasonal - drug therapy; Rhinitis, Allergic, Seasonal - physiopathology; spirometry; Treatment Outcome
• ISSN: 0091-6749; 1097-6825
• DOI: 10.1016/S0091-6749(97)70274-4

Background: Antihistamines have been shown to have a variety of therapeutic effects in asthma. Although nasal obstruction may play an important role in modulating lower airway function, no prior trial has used a decongestant in combination with an antihistamine in patients with allergic rhinitis and concomitant asthma. Objective: We sought to determine the efficacy and safety of loratadine (5 mg) plus pseudoephedrine (120 mg) (L/P) twice daily in patients with seasonal allergic rhinitis and mild asthma. Methods: We conducted a randomized, double-blind, placebo-controlled trial of L/P in 193 subjects during the fall allergy season. Nasal and chest symptoms, albuterol use, and peak expiratory flow 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. Results: Total rhinitis and asthma symptom severity scores were significantly reduced in patients receiving active therapy compared with those receiving placebo throughout the 6-week study. Peak expiratory flow rates 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 placebo, 8.52 ± 3.53 L/min, p = 0.002) as did FEV 1 (peak effect [mean ± SEM]: L/P, 170 ± 53 ml vs placebo, 20 ± 40 ml, p = 0.01) at all clinic visits. In addition, select measures of asthma-specific quality 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. (J Allergy Clin Immunol 1997;100:781-8)