Original Articles: Interventions
Combination therapy with azelastine hydrochloride nasal spray and fluticasone propionate nasal spray in the treatment of patients with seasonal allergic rhinitis

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Background

To our knowledge, there are no published studies that evaluated the efficacy of azelastine hydrochloride nasal spray in combination with an intranasal corticosteroid, although anecdotal reports of the use of these agents in combination are common.

Objective

To determine if greater efficacy could be achieved with the intranasal antihistamine azelastine and the intranasal corticosteroid fluticasone propionate used concurrently compared with the efficacy of each agent alone.

Methods

This randomized, 2-week, multicenter, double-blind trial was conducted during the Texas mountain cedar season. After a 5-day placebo lead-in period, 151 patients with moderate to severe nasal symptoms were randomized to treatment with the following: (1) azelastine nasal spray, 2 sprays per nostril twice daily; (2) fluticasone nasal spray, 2 sprays per nostril once daily; or (3) azelastine nasal spray, 2 sprays per nostril twice daily, plus fluticasone nasal spray, 2 sprays per nostril once daily. The primary efficacy variable was the change from baseline in the total nasal symptom score (TNSS), consisting of sneezing, itchy nose, runny nose, and nasal congestion.

Results

All 3 groups had statistically significant (P < .001) improvements from their baseline TNSS after 2 weeks of treatment. The TNSS improved 27.1% with fluticasone nasal spray, 24.8% with azelastine nasal spray, and 37.9% with the 2 agents in combination (P < .05 vs either agent alone). All 3 treatments were well tolerated.

Conclusions

The significant improvement in the TNSS with combination therapy relative to the individual agents alone is in contrast to previously published studies that found no advantage with an oral antihistamine and an intranasal corticosteroid in combination. Azelastine nasal spray and fluticasone nasal spray in combination may provide a substantial therapeutic benefit for patients with seasonal allergic rhinitis compared with therapy with either agent alone.

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.

REFERENCES (28)

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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.

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