MCW to design national clinical trial for treatment of a lung disease in primary immunodeficiency
Aug. 07, 2014 College News - The Medical College of Wisconsin (MCW) and the Children’s Hospital of Wisconsin Research Institute have received a one-year, $280,000 grant from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases to design a multi-center clinical trial.
John Routes, MD, professor and chief of asthma, allergy, and immunology at MCW and medical director of asthma, allergy and clinical immunology at Children’s Hospital of Wisconsin, is the primary investigator on the project.
Common variable immune deficiency (CVID) is a fairly rare disorder (1 in 25,000) that impairs the immune system, making people highly susceptible to infections. Ten to 15 percent of patients with CVID develop a complication called granulomatous/lymphocytic interstitial lung disease (GLILD), which is a progressive disease that restricts the ability to breathe, and is a significant cause of death in immune-compromised patients who develop GLILD.
There is no established standard of care for treating GLILD. However, Dr. Routes’ research team recently found an immunosuppressive therapy using two FDA-approved drugs improved the lung function in a select group of patients with GLILD.
With this grant funding, Dr. Routes will design a multicenter, placebo controlled trial for patients with GLILD. Designing a trial includes recruiting a sufficient number of investigators and centers, developing a leadership structure, establishing clinical and scientific cores, creating regulatory documents and manuals of procedures, and developing a database for data collection.