Study Shows New Investigational Corticosteroid Spray Decreases Hay Fever Symptoms In Young Children

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NEW ORLEANS, March 19, 1996 -- A new investigational once-daily water-based nasal spray, Nasacort AQ (triamcinolone acetonide), can safely and effectively treat hay fever symptoms in patients as young as six years of age, according to the results of a new study presented today at the 52nd Annual Meeting of the American Academy of Allergy, Asthma, and Immunology.

Hay fever -- also called seasonal allergic rhinitis -- is a common health problem, affecting approximately 22 million Americans of all ages.

The new data showed that Nasacort AQ, a nasally inhaled corticosteroid, relieves hay fever symptoms caused by an allergy to grass pollen in children ranging from six to eleven years of age.

"Since 16 percent of all six to 12-year-olds have hay fever, it is important to develop simple, safe, and effective treatments for this population," said Guy Settipane, M.D., clinical professor of medicine at Brown University in Providence, Rhode Island, and one of the trial's lead investigators. "Our findings strongly suggest that Nasacort AQ can help satisfy this objective."

The Phase III trial included 223 children ranging from six to 12 years of age who had a history of hay fever induced by an allergy to spring grass and whose symptoms had not been adequately controlled by antihistamines, decongestants, and/or immunotherapy.

Patients were randomized to treatment with once-daily Nasacort AQ (110 micrograms or 220 micrograms -- the equivalent of one or two sprays per nostril) or a placebo nasal spray.

Both doses of Nasacort AQ provided significantly better relief of nasal allergy symptoms -- runny nose, stuffiness, sneezing, and itching than did placebo over the course of the two-week trial, Dr. Settipane reported. The improvement in symptoms occurred as early as the first day of treatment.

Overall, both patients and physicians reported that they preferred Nasacort AQ to the placebo preparation.

Adverse events were equally uncommon in all three treatment groups, and no patient had to withdraw from the study prematurely because of a treatment-related side effect. The most frequent complaint was nasal irritation.

While prior clinical trials have documented the effectiveness of Nasacort AQ in patients between 12 and 80 years of age, our study demonstrates its potential role in young children," said Dr. Settipane. "The fact that this medication can be taken once daily is also an important consideration given that the multiple daily dosing required with most other hay fever medications has been associated with reduced patient compliance and an inadequate therapeutic response."

Hay fever is caused by an allergic sensitivity to pollens from trees, grasses, or weeds, or to airborne mold spores and typically occurs during spring, summer and fall. When affected persons breathe in pollens or molds, their immune system releases the chemical histamine, which then produces inflammation and swelling of the fragile lining of the nose, sinuses, eyelids, and surface layer of the eyes.

Resulting symptoms commonly include nasal congestion, runny nose, sneezing, runny eyes, and an itching sensation in the nose and throat and on the upper part of the mouth.

Nasacort AQ is being developed by Rhone-Poulenc Rorer Inc. (NYSE: RPR), a global pharmaceutical company dedicated to improving human health.

CONTACT: Jim Weiss and Bob Pearson of Rhone-Poulenc Rorer, 610-454-2323, ext. 3872