Original Articles: InterventionsCombination therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis
Section snippets
INTRODUCTION
The most commonly used agents in the treatment of seasonal allergic rhinitis (SAR) are oral antihistamines and intranasal corticosteroids. Clinical studies1, 2 have shown that the second-generation antihistamines, cetirizine and fexofenadine, provide approximately equal therapeutic efficacy, whereas the efficacy of cetirizine seems to exceed that of loratadine.3, 4, 5 Reviews6, 7 of well-controlled clinical trials that directly compared an intranasal corticosteroid with an oral antihistamine
Patients
The study population consisted of patients 12 years and older with a minimum 2-year history of allergy to Texas mountain cedar (Juniperus ashei) pollen, as confirmed by a positive allergy skin test result within the past year. Use of concomitant medications was discontinued for specified times, based on the elimination half-life of each drug, before patients began the double-blind treatment period. All patients or their guardians (if the patient was aged <18 years) signed an institutional
Disposition of Patients
A total of 151 patients were randomized to double-blind treatment at 5 study centers. Of the 151 randomized patients, 150 had postbaseline diary data and were included in the efficacy analysis. Data for all 151 randomized patients were included in the safety analysis. A total of 147 patients completed all 14 days of the double-blind treatment period. All of the patients in the azelastine nasal spray group completed 14 study days. In the fluticasone group, 1 patient withdrew consent and 1
DISCUSSION
In this study, significantly greater efficacy was achieved by combination therapy with an antihistamine nasal spray and an intranasal corticosteroid spray, when compared with either agent alone.
Azelastine nasal spray plus fluticasone nasal spray provided greater than 40% relief of the TNSS relative to fluticasone alone and greater than 48% relief of nasal congestion relative to fluticasone alone. All of the individual symptoms of the TNSS were improved with combination therapy when compared
ACKNOWLEDGMENTS
We thank Carrie D’Andrea, MS, MedPointe Pharmaceuticals, Somerset, New Jersey, for clinical trial management; and i3 Statprobe, Ann Arbor, Michigan, for statistical analysis of the data.
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Disclosures: Drs Ratner, Hampel, Van Bavel, Amar, and Daftary received research grants for conducting this study, and Drs Wheeler and Sacks are employees of MedPointe Pharmaceuticals.
Sources of Funding: This study was supported by MedPointe Pharmaceuticals.