REPORTING FROM AAAAI/WAO JOINT CONGRESS

ORLANDO (FRONTLINE MEDICAL NEWS) – Twice-daily treatment with a combination of olopatadine and mometasone showed significant clinical benefit and demonstrated safety for patients with seasonal allergic rhinitis, according to the results of a phase 3 trial.

The combination, known as GSP301, is a fixed-dose nasal spray containing olopatadine, a Food and Drug Adminstration–approved antihistamine, and mometasone, an FDA-approved corticosteroid.

In a double-blind, parallel-group study , Frank Hampel, MD, of Central Texas Health Research in New Braunfels, Tex., and his colleagues randomized 1,180 patients who had seasonal allergic rhinitis and were aged 12 years or older to receive GSP301 (olopatadine 665 mcg/mometasone 25 mcg), olopatadine (665 mcg) alone, mometasone (25 mcg) alone, or placebo twice daily. They examined change from baseline in reflective total nasal symptom scores and compared the changes across treatment groups. The mean change in baseline scores was the primary endpoint.

The combination therapy demonstrated statistically significant improvement in scores, compared with those associated with placebo (P less than .001) and olopatadine alone (P = .003). It also showed benefit when compared with mometasone alone (P = .059), Dr. Hampel reported at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Allergy Organization.

“You expect this outcome,” Dr. Hampel said in an interview. “Olopatadine is a good drug, mometasone is a good drug, so you’d expect the combination to be good, and it was.”

Dr. Hampel and his colleagues also analyzed changes in baseline scores for patients in the olopatadine group and the mometasone group and compared those changes with those seen in the placebo group. Patients in the mometasone group experienced statistically significant improvement, compared with those in the placebo group (P = .004), and patients in the olopatadine group also appeared to experienced benefit (P = .076).

Adverse events were similar across all treatment groups, although a slightly higher percentage of patients in the GSP301 group (12.9%) and olopatadine groups (12.5%) experienced adverse events, Dr. Hampel said.

Glenmark Pharmaceuticals sponsored the study. Dr. Hampel reported funding from Glenmark Pharmaceuticals and other pharmaceutical companies

fpnews@frontlinemedcom.com

SOURCE: Hampel F et al. AAAAI/WAO Joint Congress, Abstract 546 .

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