Summary

A 2-week study in people with ashe juniper allergic rhinitis shows that a combination of an antihistamine nasal spray and a corticosteroid nasal spray has greater effectiveness than either medication alone.

Introduction

Most people with seasonal allergic rhinitis, or hay fever, start their treatment with an antihistamine, and, if that doesn't help sufficiently, switch to an intra-nasal corticosteroid. Two popular nasal sprays are the antihistamine azelastine (Astelin^®) and the steroid fluticasone (Flonase^®). A group of allergy specialists in Texas have studied the effect of a combination of these two drugs compared with the effects of either given alone. They wanted to know if simultaneous use of two effective agents with different mechanisms of action would have unexpected advantages. They reported their findings in the Annals of Allergy, Asthma & Immunology, and we summarize them here.

What was done

The study was done during the Texas mountain cedar season. This tree is actually a juniper, commonly known as ashe juniper; in Texas, the season is at a peak in January. The study was conducted between December 2005 and February 2006 at 5 sites; pollen counts were done at each site to ensure there was exposure to the allergen.

The patients had to have at least 2 years' history of allergy to the ashe juniper, confirmed by a positive skin test in the previous year. A 5-day placebo treatment period was used to ensure that the patients' recorded symptoms - their total nasal symptom score, or TNSS - were high enough to justify enrollment for the study treatments. They were then randomly assigned to one of three treatment groups: (1) Astelin nasal spray, 2 sprays per nostril twice a day; (2) Flonase nasal spray, 2 sprays per nostril once a day; or (3) Astelin and Flonase sprays, given as in the previous groups. The medications were prepared so that the study was double-blind, i.e. neither the patient nor the doctor knew to which treatment group the patient belonged. Patients recorded their TNSS scores twice a day, just before administration of the drugs.

The prime measure of effectiveness was change from baseline to day 14 of active treatment in the TNSS, which covered the symptoms sneezing, itchy nose, runny nose, and nasal congestion.

What was found

A total of 147 patients completed all 14 days of the double-blind treatment. Their average age was 37; most of them were women, and the average duration of their ashe juniper allergy was 17 years.

After 2 weeks of treatment, all 3 groups had significant improvements from their baseline TNSS. The actual improvements were 27.1% with Flonase alone, 24.8% with Astelin alone, and 37.9% with both drugs taken together. The combination treatment improved all 4 individual TNSS symptoms compared with the individual drugs.

All three treatments were well tolerated. Astelin produced a bitter taste in 8%, while headache was reported by 4% of patients in the two individual drug groups and 5.8% in the combination group.

Conclusions

This simple but well-designed study showed clearly that the combined use of two seasonal allergic rhinitis treatments was significantly superior to the use of either treatment alone. The authors of the study point out that this result stands in contrast to previously published studies that found no advantage in a combination of an oral antihistamine with an intranasal steroid - a combination that is probably prescribed most frequently. They write: "the substantial improvements with combination therapy in the present study suggest that in addition to differences in mechanism of action between antihistamines and corticosteroids, the ability to direct the medication to the target tissue is an important determinant of the effectiveness of this combination." In simpler words, the use of Astelin nasal spray, rather than a tablet, was what made the difference.

These results represent an important improvement in the treatment of seasonal allergic rhinitis. It must be noted that the study was supported by Medpointe Pharmaceuticals, the manufacturer of Astelin, and two of the five authors of the study report were Medpointe employees. Additional independent studies should firm up this concept in the treatment of a distressing, if non-serious, condition.