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Request for AIED patients--AAO-HNS study

Jeffrey Sirianni audioman at hctc.net
Wed Jun 10 16:29:44 EST 1998

 From ASHA Listserve....

>Resent-Date: Tue, 9 Jun 1998 18:07:47 -0400
>Date: Tue, 09 Jun 1998 17:57:48 -0400
>From: "Evey Cherow" <Echerow at asha.ORG>
>To: asha-aud-forum at postman.com
>Cc: lincolnc at aol.com
>Subject: Request for AIED patients--AAO-HNS study
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>AAO-HNS has asked me to post this request for patients for a study on
autoimmune ear disorders. 
>Have You Seen This Patient?
>Announcing ... a new investigation of autoimmune ear disorder (AIED) by
the Otolaryngology Clinical Trials Cooperative Group (OCTCG), an
NIH-sponsored project of the American Academy of Otolaryngology--Head and
Neck Surgery Foundation.
>Will you help us find patients for a new multi-institutional, prospective,
double blind, placebo-controlled clinical study?  To assess the benefits
and risks of treating AIED with three different immunosuppressive drugs:
prednisone, methotrexate, and cyclophosphamide, we are looking for men and
women, over 18 and under 70 years old, in good health, with
>*	Bilateral sensorineural hearing loss of 30 dB or greater
>*	Progression of hearing loss within the prior three months
>*	Idiopathic etiology, as evaluated by an otolaryngologist and using
appropriate blood tests and radiographic imaging
>*	Willing to attend a site once every three to six weeks over an 18-month
>AIED Clinical Trials Centers and Investigators
>	University of California at San Diego, CA: Jeffrey P. Harris, MD, PhD
619-657-8683 Fax 619-657-8682
>	Cleveland Clinic Foundation, OH: Gordon B. Hughes, MD 216-444-5375 Fax
>	House Ear Institute, Los Angeles, CA: Ralph A. Nelson, MD 213-483-9930
Fax 213-484-5900
>	University of Iowa, Iowa City, IA: Bruce J. Gantz, MD 319-356-2173 Fax
>	Massachusetts Eye and Ear Infirmary, Boston, MA: Steven D. Rauch, MD
617-573-3644 Fax 617-573-3939
>The trials run from summer 1998 to late 2003.
>For more information or to send the name of a patient, contact OCTCG,
AAO-HNSF, One Prince Street, Alexandria, VA 22314-3357, phone 703-836-4444,
fax 703-683-5100, e-mail auntiemo at aol.com
>Name of patient
>Name of referring physician
>Physician address
>Street address
>City State ZIP+4
________ at _________
>Phone				Ext. 			Fax 					E-mail
>Rapidly progressive hearing loss is a frightening prospect to anyone.
Just imagine--one day you have normal hearing and the next day your hearing
begins to deteriorate, rapidly and in both ears, devastating many aspects
of your life, including job performance and quality of life.  Left
untreated, this potentially devastating condition can progress to total
deafness and dysequilibrium.
>Autoimmune inner ear disease (AIED) is one form of idiopathic,
progressive, bilateral sensorineural hearing loss (IPBSNHL) that occurs
over weeks to months and affects hearing, and often vestibular function, in
both ears.  As physicians to these patients, you will likely recognize the
problem yet may feel poorly informed as tocurrent intervention strategies.
The ability to institute prompt and effective treatment once the likelihood
of immune-mediated sensorineural hearing loss is identified is of paramount
importance; in so doing, the opportunity to reverse or at least stabilize
the hearing loss is maximized.
>Because abundant evidence suggests that AIED is caused by inflammation and
altered immunity, available treatment choices for this condition include
classes of immunosuppressive drugs often used to treat more common
conditions as rheumatoid arthritis or cancer.  High dose prednisone,
methotrexate, and cyclophosphamide are currently used but with little
guidance regarding dosage or duration of therapy and less than adequate
proof of efficacy.  This uncertainty is coupled with the knowledge that the
short and long term toxicities of these products, particularly prednisone
and cyclophosphamide, can be quite disabling, curtailing their usefulness
in any condition other than self-limiting or life-threatening diseases.
>As the first study under the NIH-sponsored Otolaryngology Clinical Trials
Cooperative Group (OCTCG), the Foundation and Academy members have launched
a multi-institutional, prospective, double blind, placebo-controlled
clinical study to assess the benefits and risks of treating AIED with three
different immunosuppressive drugs: prednisone, methotrexate, and
cyclophosphamide.  In particular, this study will examine whether
methotrexate, the least toxic treatment choice, improves hearing in AIED
patients who showedan initial benefit from short-term prednisone therapy.
We will also study whether or not persons whose hearing does not improve
with prednisone therapy can still benefit from either methotrexate or
cyclphosphamide therapy.  A third aim is to determine whether laboratory
and clinical risk factors can be identified that are  predictive of
therapeutic outcomes in patients with AIED.
>Patients eligible for study will undergo a 30-day trial of prednisone.
If, after 30 days, their hearing improves, patients will be randomized to
receive either methotrexate or a placebo.  Patients' hearing will be tested
at regular intervals and, if their hearing worsens at any time during the
study, they will discontinue their treatment regimen and be available to
receive non-study treatment.  Ultimately, patients may be followed for a
total of 18 months.  Because AIED is rare, probably accounting for less
than one percent of all cases of hearing impairment or dizziness, the
success of this trial will rely on our ability to recruit and study more
than 175 patients with AIED during the next 3-1/2 years who meet a specific
set of inclusion/exclusion criteria.  If you have patients who meet the
inclusion criteria and are able to travel to one of the five study
institutions, please consider referring them to participate in this
important effort.  Their participation will not only help us determine how
to best treat this potentially debilitating condition, but perhaps lead to
better understanding of the disease and whether or not laboratory and
clinical risk factors can predict treatment outcomes.
>An application for support of a second trial, studying the effectiveness
of Dyazide in treating the symptoms of early Meniere's disease, has been
submitted to NIDCD.  If funded, the new trial will begin enrolling patients
in 10 clinical centers in Fall, 1998.
>For more information about the AIED study or the OCTCG program in general,
please contact Patrick Brookhouser MD, Principal Investigator, at
402-498-6501 or Maureen Hannley PhD, Group Coordinator for the grant at
703-519-1547.  If you have other questions about autoimmune related
diseases, consider visiting the website for the American Autoimmune Related
Diseases Association at www.aarda.org.
> Exclusion Criteria
>1.	Systemic diseases that increase patient risk from immunosuppressive
>*	Active malignancy or prior chemotherapy
>*	Alcohol abuse
>*	Corticosteroid use for more than 30 days in past 90 days
>*	History of tuberculosis or prophylactic INH treatment
>*	Insulin-dependent diabetes
>*	Pancreatitis, peptic ulcer disease, or renal insufficiency
>*	Positive evidence of HIV, Hepatitis B, or Hepatitis C
>*	Shingles
>*	Other systemic autoimmune or inflammatory diseases, such as rheumatoid
arthritis, Wegener's granulomatosis, 	Graves disease, or lupus.
>2.	Otological diseases suggesting non-AIED etiology
>*	Chronic suppurative otitis media
>*	Cochlear otosclerosis
>*	Cogan's syndrome
>*	Developmental craniofacial abnormalities
>*	Genetic or progressive sensorineural hearing loss as a child
>*	Idiopathic sudden sensorineural hearing loss (within 24 hours)
>*	Luetic deafness
>*	Perilymph fistula
* Jeff Sirianni, M.A., CCC-A                      *
* Sound Advice / R.G. Delaney, M.D.               *
* 710 Water Street / Suite 404                    *
* Kerrville, TX  78028                            *
*                                                 *
* (830) 896-1433                                  *
* (830) 896-1440 FAX                              *
*                                                 *
* audioman at hctc.net                               *
*                                                 *
* Discussion Leader of bionet.audiology Newsgroup *

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