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Fludrocortisone for Sudden Hearing Loss

This study is currently recruiting participants.
Verified August 2011 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: August 19, 2011
Last verified: August 2011
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 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186185

Contacts
Contact: Anh Nguyen-Huynh, MD PhD 503-494-8135 nguyanh@ohsu.edu
Contact: Yong-Bing Shi, MD PhD 503-494-7954 shib@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    
Contact: Yong-Bing Shi, MD PhD     503-494-7954     shib@ohsu.edu    
Principal Investigator: Anh Nguyen-Huynh, MD PhD            
Sub-Investigator: Yong-Bing Shi, 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

No publications provided

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: August 19, 2011
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
Fludrocortisone
Mineralocorticoids
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 17, 2012