Azelastine Plus Fluticasone Nasal Spray Relieves Symptoms of Allergic Rhinitis

Deborah Brauser

November 13, 2009

November 13, 2009 (San Diego, California) — A combination of azelastine hydrochloride and fluticasone propionate nasal sprays administered in a single delivery device can significantly improve both nasal and ocular symptoms in patients with moderate to severe seasonal allergic rhinitis (SAR), according to a new randomized placebo-controlled study.

Results were presented here at the American College of Allergy, Asthma & Immunology (ACAAI) 2009 Annual Scientific Meeting in a podium session by Paul Ratner, MD, allergist/immunologist and founder and director of Sylvana Research, of San Antonio, Texas, a research facility for investigational medications.

"This study is important because if you look at statistics and at people with increasing severity of their allergies, you see an increasing amount of ocular symptoms," said Dr. Ratner in an interview with Medscape Allergy and Immunology.

He reported that about 75% of the most severe SAR patients complain of itchy eyes and about two thirds of them complain of watery eyes. "It's a very common symptom complex that you see along with the nasal congestion and runny nose and other things that come with allergies."

Growing Interest in Combination Treatment

"Recently, there's been a lot of interest in looking at combinations of nasal antihistamines and nasal corticosteroids, with previous studies showing that the combination is more effective statistically than the single entities," said Dr. Ratner. "In this study, we wanted to look specifically at the ocular effects from treatment with this combination."

His investigational team enrolled 610 patients with ocular symptoms from SAR during the 2007/08 Texas Mountain Cedar season. The patients were randomized to 1 of 4 groups receiving 1 spray per nostril twice daily: azelastine alone, fluticasone alone, azelastine plus fluticasone, and placebo.

The primary end point was efficacy, defined as a change from baseline in the total nasal symptom score (TNSS) for nasal congestion, sneezing, itchy nose, and runny nose.

The secondary end point was the effect of azelastine plus fluticasone on the total ocular symptom score (TOSS) for itchy eyes, watery eyes, and redness.

Nasal and Ocular Symptoms Improved

Results showed that improvements on TNSS were statistically significant for the patients treated with the combination spray (31.3%), compared with those treated with fluticasone alone (20.8%), azelastine alone (16.3%), or placebo (9.0%; < .001).

There was also a statistically significant improvement in TOSS for those treated with the combination spray (26.4%), compared with those treated with azelastine alone (19.3%), fluticasone alone (16.6%), or placebo (8.9%; < .001).

The only adverse events reported by more than 2% of those treated with the combination spray were bitter taste (7.2%), epistaxis (3.9%), and headache (2.6%).

"There are 2 key points to this study," said Dr. Ratner. "The first is that the combination therapy with nasal antihistamines and nasal steroids is definitely panning out to be more effective than treatment with the individual components. Second, in addition to treating the nasal symptoms that you would expect, you're also getting the added benefit of having relief of the ocular symptoms."

He added that "if you look at the way allergists are practicing now, I'd say that they're using both drugs in combination in 30% to 40% of their patients. The advantage and ability to have a product that would reflect that combined therapy in a single inhaler is something I think would definitely enhance the treatment of patients."

Treat the Eyes and the Nose

"I think the take-away from this study is to remember that the nose and the eyes go hand and hand," said ACAAI abstract review committee chair John J. Oppenheimer, MD, associate clinical professor of medicine at New Jersey Medical School in Newark.

"When we think about allergic rhinitis, we forget that the eyes come along. There have been a lot of really elegant studies showing that the ocular complaints in these patients are really quality-of-life diminishing. So what this study reinforces is that polypharmacy, using an antihistamine blocker as well as a nasal steroid, may be a more effective modality in treating this ocular complaint and the nasal symptoms," said Dr. Oppenheimer, who was not involved with this study.

He added: "I think more research is needed to help us try to tease out what the most important parts are. Patients with [SAR] really suffer and every year they know they're going to be doomed by this illness. I think being able to provide better interventions for them is really going to be my hope for the future. It's just really important for us to do a better job."

This study was funded by Meda Pharmaceuticals. Dr. Ratner has disclosed no relevant financial relationships. Dr. Oppenheimer reports being a consultant and doing research for Glaxo, AstraZeneca, Schering, Merck, Novartis, and Genentech.

American College of Allergy, Asthma & Immunology (ACAAI) 2009 Annual Scientific Meeting: Abstract 26. Presented November 8, 2009.