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Fludrocortisone for Sudden Hearing Loss

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
Anh Nguyen-Huynh, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01186185
First received: August 19, 2010
Last updated: April 21, 2015
Last verified: April 2015
History of Changes
  Purpose
The standard of care treatment of sudden hearing loss uses a type of steroid called glucocorticoid. Examples of glucocorticoids are prednisone, methylprednisolone and dexamethasone. Not everybody recovers hearing with glucocorticoid treatment. Fludrocortisone is a different type of steroid called mineralocorticoid. Unlike glucocorticoids, which work by reducing inflammation, mineralocorticoids work by changing salt and fluid balance. In animal studies, fludrocortisone is at least as effective as glucocorticoid in preserving hearing. Fludrocortisone is not approved for the treatment of sudden hearing loss. The purpose of this study is to test whether fludrocortisone can treat sudden hearing loss.

Condition Intervention
Hearing Loss, Sensorineural
 Drug: Fludrocortisone

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Hearing [ Time Frame: At one month ] [ Designated as safety issue: No ]
    Hearing outcome will be determine by pure-tone and speech audiometry measured at the completion of a one-month course of treatment and compared with pre-treatment test results.
Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fludrocortisone Drug: Fludrocortisone
Fludrocortisone 0.2 mg by mouth daily for 30 days

  Eligibility
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Idiopathic sudden sensorineural hearing loss within 3 months
  • Failure to recover hearing with glucocorticoid treatment or inability to tolerate glucocorticoid

Exclusion Criteria:

  • Other diagnosis for the sudden hearing loss
  • Concurrent systemic use of another steroid
  • Hypersensitivity to fludrocortisone
  • Systemic fungal infection
  • Hypertension requiring two or more medications
  • Pitting edema
  • Cardiomegaly
  • Congestive heart failure
  • Electrolyte abnormality
  • Concurrent use of barbiturates, phenytoin, fosphenytoin, rifampin, or rifapentine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186185

Contacts
Contact: Anh Nguyen-Huynh, MD PhD 503-494-8135 nguyanh@ohsu.edu

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Anh Nguyen-Huynh    503-260-9192    nguyanh@ohsu.edu   
Principal Investigator: Anh Nguyen-Huynh, MD PhD         
Sponsors and Collaborators
Oregon Health and Science University
Investigators
Principal Investigator: Anh Nguyen-Huynh, MD PhD Oregon Health and Science University
  More Information

Responsible Party: Anh Nguyen-Huynh, Assistant Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01186185     History of Changes
Other Study ID Numbers: IRB00006240 
Study First Received: August 19, 2010
Last Updated: April 21, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
sudden
sensorineural
hearing loss
 fludrocortisone
mineralocorticoid
steroid

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Mineralocorticoids
Fludrocortisone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on September 30, 2016