Fran Lowry

November 16, 2011

November 16, 2011 (Boston, Massachusetts) — A novel nasal-spray formulation that combines the intranasal antihistamine azelastine with the intranasal corticosteroid fluticasone provides greater pharmacotherapeutic benefits for the treatment of seasonal allergic rhinitis than either of these agents alone, according to a study presented during an oral session here at the American College of Allergy, Asthma & Immunology 2011 Annual Scientific Meeting.

"There are many patients with moderate or severe allergic rhinitis whose symptoms are not adequately controlled with the currently available pharmacological agents," Eli O. Meltzer, from the Allergy and Asthma Medical Group and Research Center in San Diego, California, told Medscape Medical News. "Because of their morbidity, it is important to seek new treatments."

Dr. Meltzer and his group evaluated the efficacy of the new compound with the investigational name of MP29-02 (Meda Pharmaceuticals) in 832 subjects with seasonal allergic rhinitis. In the 2-week double-blind placebo-controlled trial, researchers randomized patients to receive MP29-02, azelastine hydrochloride 548 µg daily, fluticasone propionate 200 µg daily, or placebo administered as 1 spray per nostril twice daily.

Patients scored the change from baseline in their reflective total nasal symptom score (rTNSS), which assessed symptoms of nasal congestion, sneezing, itchy nose, and runny nose on a 4-point scale.

The investigators found that during the 2-week treatment period, patients randomized to MP29-02 had a greater decrease in their rTNSS than patients in the other treatment groups. The mean reduction in rTNSS from baseline in the MP29-02 group was 5.61, compared with 4.23 in the azelastine group (P = .001); 4.71 in the fluticasone group (P = .034), and 2.92 in the placebo group (P < .001).

Relief of symptoms occurred sooner with MP29-02, Dr. Meltzer reported. By the first evaluation day, the reduction in the rTNSS from baseline was 4.22 in the MP29-02 group, compared with 2.98 in the azelastine group (P = .007), 3.10 in the fluticasone group (P = .013), and 2.03 in the placebo group (P < .001).

Adverse events were similar in all treatment groups. The most common adverse events with MP29-02 were dysgeusia in 2.4% of subjects, epistaxis in 1.0%, and nasal discomfort in 1.0%.

"The results of this head-to-head study with MP29-02 suggest that stepping up to the combination of the intranasal antihistamine and the intranasal corticosteroid provides greater benefit than treating with these agents as monotherapies," Dr. Meltzer concluded. "These data present a new option for clinicians and patients."

National guidelines have been in agreement with this for the past several years, said session comoderator Mark Dykewicz, MD, from Wake Forest University in Winston-Salem, North Carolina.

Dr. Dykewicz, who was invited to comment on the study by Medscape Medical News, said that the 2008 Rhinitis Parameter Update of the US Joint Task Force on Practice Parameters stated that using this combination was effective.

"In contrast, most studies have failed to demonstrate that the addition of an oral antihistamine to an intranasal corticosteroid adds to the benefit of the intranasal corticosteroid," Dr. Dykewicz said.

"However, this approach can be inconvenient because 2 separate prescription sprays must be taken, often spaced out by a 10 to 15 minute interval. MP29-01 has both the nasal antihistamine azelastine and the nasal corticosteroid fluticasone propionate, the ingredient sold as Flonase, in the same spray, and would therefore be more convenient for patients to use," he said.

Dr. Meltzer reports financial relationships with Alcon, Amgen, Boehringer Ingelheim, Dey Greer, ISTA, Johnson & Johnson, Kalypsys, Meda Pharmaceuticals, Merck, Ono, Rady, Sandoz, Sunovion, Stallergenes, Teva, GlaxoSmithKline, Nycomed, SanofiUS, Alexza, Astellas, Forest, Map, Medimmune and Novartis. Dr. Dykewicz reports financial relationships with Merck and Shire.

American College of Allergy, Asthma & Immunology (ACAAI) 2011 Annual Scientific Meeting: Abstract 39. Presented November 7, 2011.