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MAY 12, 2009

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Hayfever, dust-mite allergy sufferers needed for Stanford/Packard study

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BY ERIN DIGITALE

 

SUMMARY
Grass pollen and dust mite allergy sufferers, ages 5 to 65, are needed for a clinical trial of a new “ouchless” alternative to allergy shots. The volunteers will take daily under-the-tongue squirts of an allergy therapy that works on the same principle as allergy shots, but without the pokes. Subjects will return to Stanford every few months for allergy tests and keep regular diaries of allergy symptoms. Prospective volunteers, who must be allergic to both grass and dust mites, can get more information on the trial by calling Lisa Hoyte at (650) 723-5227 or e-mailing ehoyte@stanford.edu.

STANFORD, Calif. — Itchy hayfever and dust-allergy sufferers must weigh an unpleasant trade-off: Struggle with red eyes, sneezing and runny noses, or endure years of shots to quell the problem.

Now, scientists at the Stanford University School of Medicine and Lucile Packard Children’s Hospital are testing another allergy-control option—something friendlier than injections and longer-lasting than popping antihistamines. They are recruiting children and adults for a yearlong study of an experimental allergy therapy that swaps painful arm-sticks for ouchless squirts of fluid under the tongue.

“Having shots is not much fun,” said Kari Nadeau, MD, PhD, an assistant professor of pediatrics at Packard Children’s who is leading the study. “We’re looking for another way to help people become tolerant to the things that trigger their allergies.”

Prospective study subjects can be children or adults ages 5 to 65 years. They must be allergic to both grass and dust mites, and must not have received allergy shots in the last three years. Subjects will receive allergy testing at the beginning of the yearlong trial, and will take the test treatment—a small amount of fluid spritzed under the tongue—daily for 12 months. They’ll pick up fresh doses of the treatment at Stanford every few months, and will be retested for allergies several times during the trial period. They will also keep regular diaries of the allergy symptoms affecting their eyes, noses, lungs and skin.

The therapy on trial follows the same principle as allergy shots. The idea is to deliver small amounts of allergy-inducing substances—in this case, grass pollen and dust mite particles—on a regular, controlled schedule, gradually dialing down the body’s bad reaction. The researchers think the allergens will be absorbed into the many tiny blood vessels that supply the area under the tongue.

Previous trials in Europe have shown some promise at delivering single allergens by this route. However, this study is the first time the sublingual approach will be tested using two allergens given simultaneously, which Nadeau said is important because many people suffer multiple allergies.

“In Europe, versions of this therapy are approved by their equivalent of the Food and Drug Administration,” Nadeau said, adding that European regulators have found the method safe and effective. “But it’s not approved in the United States yet. That’s why we need to do clinical trials here.”

The study is funded by a philanthropic donation to the Lucile Packard Foundation for Children’s Health. The allergen extracts used in the therapy were donated by the pharmaceutical company Greer Laboratories of Lenoir, N.C.

“Right now, people have to come to a doctor’s office to get allergy shots,” Nadeau noted. “With this sublingual immunotherapy approach, most patients would be able to take the therapy at home. That’s a great benefit.”

Individuals who would like to volunteer for the trial should contact Lisa Hoyte at (650) 723-5227 or e-mail ehoyte@stanford.edu for more information.

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The Stanford University School of Medicine consistently ranks among the nation’s top 10 medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.

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