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Title: Combination of Azelastine and Fluticasone Improves Symptom Relief in Patients With Allergy to Texas Mountain Cedar: Presented at ACAAI

"Combination of Azelastine and Fluticasone Improves Symptom Relief in Patients With Allergy to Texas Mountain Cedar: Presented at ACAAI"

By Corinna S. Bowser, MD PHILADELPHIA, PA -- November 15, 2006 -- Azelastine nasal spray (Astelin) in combination with fluticasone nasal spray (Flonase) provided roughly 40% more relief in patients with allergy to Texas mountain cedar compared with fluticasone nasal spray alone, investigators reported here at the 2006 Annual Meeting of the American College of Allergy, Asthma and Immunology (ACAAI). The combination therapy improved symptoms within 24 hours, with increasing improvement seen during the entire 14-day duration of the trial, said investigator Paul Ratner, MD, allergist in private practice, and medical director, Sylvana Research Associates, San Antonio, Texas. The combination of azelastine and fluticasone was "extremely well tolerated," Dr. Ratner added in an oral presentation on November 11[^th.

Incidence of headaches was 5.8% for patients receiving both nasal sprays, and about 4% for patient who received either agent alone. No other adverse events were reported by more than 1 patient in any treatment group, and no patients discontinued due to adverse events during the trial.

This postmarketing, non-placebo-controlled study included 151 highly symptomatic patients treated at 1 of 5 sites during Texas mountain cedar season.

The primary efficacy variable was the change from baseline to day 14 in the Total Nasal Symptom Score (TNSS), consisting of sneezing, itchy nose, runny nose, and nasal congestion. All treatment groups had statistically significant (P < .001) improvements from their baseline TNSS.

Over the course of this 14-day study, mean improvement in TNSS from baseline was 38% with fluticasone and azelastine in combination, 27% with fluticasone alone, and 25% with azelastine alone (P < .05). Relative to fluticasone alone, the increase in efficacy was roughly 40%, Dr. Ratner noted.

The combination spray was associated with bitter taste in 13.5% of patients compared with 8.2% of patients on azelastine alone and 2.0% of patients on fluticasone alone.

"The magnitude of improvement was surprising to everyone involved in this study," Dr. Ratner said. "It was not anticipated based on previous trials in which oral antihistamines had been put in combination with intranasal steroids, where that (approach) did not show any added effect of the combination."

[Presentation title: Randomized, Double-Blind Trial of Azelastine Nasal Spray Plus Fluticasone Nasal Spray Compared to Either Agent Alone in Patients With Allergy to Texas Mountain Cedar. Abstract 28]

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