Mometasone Furoate Nasal Spray Eases Eye Symptoms of Seasonal Allergies

Karla Gale, MS

May 21, 2010

May 21, 2010 — Once-a-day mometasone furoate nasal spray (Nasonex) relieves both nasal and ocular symptoms of seasonal allergic rhinitis, phase III trial results indicate.

"This information is something the average practicing physician can use, to first start a drug like this for both nasal and ocular symptoms, and hopefully get through the season without having to prescribe additional medications," first author Dr. Bruce M. Prenner told Reuters Health.

Ocular symptoms such as itching, watering, tearing, and redness bother up to 85% of people with allergic rhinitis, and more than half experience them as "moderately to extremely bothersome," investigators note in their May 3rd online paper in the Journal of Allergy and Clinical Immunology. A single agent to treat both nasal and ocular symptoms could improve patient adherence, cost-effectiveness, and side effect profile, they say.

Dr. Prenner, from Allergy Associates Medical Group, San Diego, California, and associates recruited 429 patients at 25 study sites in the U.S. Patients were at least 12 years old, with a minimum 2-year history of seasonal allergic rhinitis. In the spring and early summer of 2007, the investigators randomly assigned them to receive either mometasone furoate (2 50-mcg sprays per nostril at about the same time each morning) or matching placebo for 15 days.

The two primary endpoints were the 15-day averages of the "instantaneous total ocular symptom score" (iTOSS) and the "instantaneous total nasal symptom score" (iTNSS). The iTOSS summed individual eye symptom scores on 4-point scales for ocular itching, tearing/watering, and ocular redness. Similarly, the iTNSS included scales for rhinorrhea, nasal congestion, nasal itching, and sneezing.

The 'Instantaneous' scores show how the patient was feeling in the morning before using the nasal drops, which is when allergy patients tend to be most symptomatic," Dr. Prenner said. "This indicator tells you if the drug carries through for 24 hours."

Mean baseline iTOSS was 6.84 (out of a possible 12) in the mometasone furoate group and 6.81 in the placebo group, indicating moderate to severe seasonal allergic rhinitis. Mometasone significantly reduced the iTOSS average compared with placebo (-1.71 vs -1.37, p = 0.026). Least squares mean changes were -1.93 and -1.49, respectively (p = 0.005).

The active drug also significantly improved individual itching/burning and watering/tear scores, the authors report.

The mean baseline iTNSS were 9.39 and 9.42 in the mometasone and placebo groups, respectively (out of a possible 16). Corresponding least squares mean changes from baseline were -2.54 and -1.66 (p < 0.001). Individual nasal symptom scores were also more improved with mometasone.

Total score on the Rhinoconjunctivitis Quality of Life Questionnaire improved by 41.5% with active treatment versus 23.4% with placebo, "with clinically meaningful improvements in domains ranging from sleep difficulties to emotional problems, including frustration and irritability."

Treatments were well tolerated, with no serious adverse events in either group.

"Evidence in the literature supports that (mometasone furoate) does not act directly on the eye – which cause glaucoma and cataracts – but by improving drainage, inhibiting histamine release, and reducing the naso-ocular reflex," Dr. Prenner said.

He added that the improved symptoms may be a class effect shared with other intranasal steroids, but further research will be required to verify that.

The study was funded by Schering Corporation, a subsidiary of Merck & Co.

J Allergy Clin Immunol. Published online May 3, 2010. Abstract

Reuters Health Information 2010. © 2010 Reuters Ltd.

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