Mometasone Furoate Nasal Spray Significantly Reduces Nasal Congestion Associated With Allergic Rhinitis: Presented at AAO-HNSF

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Title: Mometasone Furoate Nasal Spray Significantly Reduces Nasal Congestion Associated With Allergic Rhinitis: Presented at AAO-HNSF
URL: http://www.pslgroup.com/dg/22D7BA.htm
Doctor's Guide
September 25, 2008

By Mary Beth Nierengarten

CHICAGO -- September 25, 2008 -- For patients with seasonal allergic rhinitis, a single treatment of mometasone furoate nasal spray significantly reduces nasal congestion within hours of administration and provides long-lasting relief after 7 days of treatment.

Anne Marie Salapatek, MSc, PhD, Research and Development, Cetero Research, Mississauga, Ontario, presented the study here at the American Academy of Otolaryngology - Head and Neck Surgery Foundation (AAO-HNSF) 2008 Annual Meeting & OTO EXPO.

Presenting the double-blind, placebo-controlled study on September 24, Dr. Salapatek emphasised that this is the earliest onset of action measured for mometasone furoate nasal spray.

Dr. Salapatek and colleagues exposed 310 ragweed-sensitive patients with seasonal allergic rhinitis to ragweed pollen in an environmental exposure chamber (EEC) for 2 hours on day 1. Patients were then given mometasone at 200 mcg or placebo. Acoustic rhinometry was used to measure congestion prior to exposure and then again 6 hours after exposure.

A subset of 155 patients received mometasone or placebo for an additional 7 days and on day 8 returned to the EEC for 4 more hours of pollen exposure.

Results show that prior to treatment with mometasone or placebo, all subjects had nasal congestion after 2 hours of EEC exposure as shown by significant decreased nostril measure on acoustic rhinometry. Six hours after treatment, nasal congestion was significantly decreased in the patients given active treatment both in comparison with their baseline measurement (P = .0001) and with placebo (P = .005).

For the subset of patients who received 7 days of additional daily treatment with mometasone or placebo, subjects in the active-treatment arm returned had significantly less congestion than those in the placebo arm, said Dr. Salapatek. In this subset, those treated with mometasone had significantly decreased congestion on day 8 compared with the placebo group prior to the second EEC pollen exposure (P = .04) as well as at 2 and 4 hours after pollen exposure (P = .01 and P = .0008, respectively).

The study also evaluated nasal congestion at 24, 26, and 28 hours after the second pollen exposure. "When patients were put back in the EEC and exposed to ragweed allergen, at the 24 hour and 26 hour [evaluation] after last mometasone treatment when mometasone is at trough levels, those treated with mometasone were protected from the congesting effects of ragweed allergen exposure compared to those with 7 days of placebo treatment," said Dr. Salapatek.

"This study is the first of its kind to demonstrate using an objective measure of nasal patency that mometasone relieves nasal congestion early after a single dose at 6 hours," she said, "and then after daily dosing for 7 days provides protection against the nasal congesting effects of controlled, high-level, ragweed allergen exposure."

She added that this finding supports previous studies showing that 7 days of daily mometasone treatment acts to prevent nasal congestion caused by allergen exposure.

According to Dr. Salapatek, using a combination of the EEC model and objective measurement of nasal patency is a superior clinical design for antiallergic drug study.

[Presentation title: Mometasone Reduces Congestion in Acoustic Rhinometry Study. Abstract S101]

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