This application seeks support for a Clinical Trials Cooperative Group dedicated to the planning, conduct, analysis, and dissemination of results of clinical studies on the treatment or management of diseases and disorders of hearing, balance, smell, taste, speech, and voice or any combination. The Group structure includes: A Central Office (CO); a Central Trials Coordination Unit (TCU) experienced in the data management and statistical aspects of clinical trials; and a network of participating Investigator Groups (IG). This application proposes the American Academy of Otolaryngology-Head and Neck Surgery Foundation, Inc. (AAO-HNSF) as the CO; a group of senior investigators at the Bowman Gray School of Medicine Dept. of Public Health Sciences as the central TCU, and a group of highly experienced, research-oriented otolaryngologists representing over 20 major public and private university medical centers in the United States as the IG. The Otolaryngology Clinical Trials Cooperative Group (OCTCG) will have overarching responsibilities related to the development of clinical trials, selection of participating units, setting standards for conduct, quality control, and publications for individual clinical trials and for enhancing the disseminatIon of results from OCTCG clinical trials. The first trial proposed will investigate treatment of autoimmune inner ear disease, a potentially devastating condition that, left untreated, can lead to total deafness and disequilibrium in a very short time period. Available treatments for this condition (high dose prednisone methotrexate, cyclophosphamide) are currently utilized without proof of efficacy or assessment of risks. Using a multi institutional, prospective, double blind, placebo controlled design, the study will address the important clinical question of whether it is an acceptable risk to treat AIED with potent and potentially toxic immunosuppressive drugs when corticosteroids fail to control the disease. The dissemination of these results through the OCTCG should allow the timely transfer of information directly to clinical practice.
| Alexander, Thomas H; Weisman, Michael H; Derebery, Jennifer M et al. (2009) Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease. Otol Neurotol 30:443-8 |
| Niparko, John K; Wang, Nae-Yuh; Rauch, Steven D et al. (2005) Serial audiometry in a clinical trial of AIED treatment. Otol Neurotol 26:908-17 |
| Harris, Jeffrey P; Weisman, Michael H; Derebery, Jennifer M et al. (2003) Treatment of corticosteroid-responsive autoimmune inner ear disease with methotrexate: a randomized controlled trial. JAMA 290:1875-83 |
