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Volunteers sought for clinical trial of new sinusitis treatment

February 19th, 2007 11:27 pm by Staff report



JOHNSON CITY - University researchers are looking for volunteers to participate in a new clinical trial of a nasal spray to treat chronic sinusitis.


The James H. Quillen College of Medicine at East Tennessee State University is testing the effectiveness of a new nasal spray called SinuNase. Developed by Accentia Biopharmaceuticals, the drug is part of a major phase three clinical trial study at approximately 50 sites across the country. As many as 300 patients are expected to enroll.


"Chronic sinusitis is one of the most common chronic diseases in the United States, and many patients have a poor quality of life in spite of medical therapy and surgery. Frequent antibiotic use and doctor or emergency room visits may complicate the condition," said Dr. Guha Krishnaswamy, chief of allergy and clinical immunology in the ETSU Department of Internal Medicine.


Symptoms of chronic sinusitis include headache, difficulty breathing through the nose, facial pain, aching sensation in teeth and jaw, and fatigue.


According to Krishnaswamy, research done at the Mayo Clinic found that airborne fungi had a significant role in the development of sinusitis and that a low-dose application of antifungals like the one involved in this study led to an improvement in symptoms.


Patients recruited for the ETSU study will receive either SinuNase or a placebo and will be required to return to the clinic for a series of follow-up visits. Some diagnostic exams will also be performed throughout the 22-week study. All study-related medication and exams will be provided free of charge.


Eligible subjects for the study include men and women who suffer from chronic sinusitis and have had at least one surgical procedure to correct the problem.


Dr. Mark Howell with Ear, Nose and Throat Associates in Johnson City is joining Krishnaswamy as a co-investigator in this project.


For information about enrolling in the study call Krishnaswamy at 794-6496 or e-mail krishnas@etsu.edu or call Dolores Moore at 439-6368 or e-mail mooreda@etsu.edu.


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