VOLUNTEERS NEEDED FOR UC DAVIS STUDY OF NEW ASTHMA MEDICATION

(SACRAMENTO, Calif.) — Patients with mild-to-moderate asthma and atopic dermatitis are needed for a UC Davis study that will investigate how a newly approved, injectable medication for the disease works.

The medication, known as Xolair®, was recently approved by the FDA for the treatment of asthma. Xolair® acts on the key molecule, called IgE, that causes allergic asthma symptoms, but the mechanism by which it does is unclear.

The UC Davis research team will be attempting to find out if Xolair® affects the levels of proteins in blood and skin cells that recognize IgE, and whether the medication decreases the production of IgE by blood cells. The study will randomly assign subjects to receive either Xolair® or an inactive substance (placebo). The study is double-blind, meaning that neither subjects nor researchers will know who is receiving the study medication.

The medication is administered by injection beneath the skin. During the study, participants will be examined every two weeks for a total of 13 visits, or every four weeks for a total of seven visits. At each visit, blood will be drawn from the participants. Depending on their visit schedule, participants will receive a total of six or 12 injections of either Xolair® or a placebo.

Visits will take place at the UC Davis Dermatology Clinic at UC Davis Medical Center. Prospective subjects will be required to make a screening visit, where they will have their blood tested, an allergy skin test, a skin biopsy and a breathing test. They also will be asked questions about their physical and mental health.

Participants who complete the study will receive $350 or $500, depending on their visit schedule. The payments will be made at the rate of $25 per visit and $50 per biopsy.

Thousands of people have received Xolair®, and side effects that could be attributed to the medication are rare. They include headaches, itchy bumps on the skin, nausea, dizziness, sweating and flu-like symptoms. Most of these symptoms are not severe. Participants also might experience other mild symptoms, such as bruising, redness or soreness at the injection site.

To be eligible for the study, prospective participants must have been diagnosed with mild-to-moderate persistent asthma for at least three months, have active atopic dermatitis, and be older than 18. The study, funded by the National Institutes of Health, will last six months.

People who have a history of a blood clotting disorder, or neurologic, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary or metabolic diseases are not eligible for the study. Nor are those who are on systemic oral medications for asthma, such as prednisone, cyclosporine or montelukast.

For more information, contact study coordinator Mercedes Barrutia at (916) 734-6547 or mercedes.barrutia@ucdmc.ucdavis.edu.