Fludrocortisone for Sudden Hearing Loss

Hearing Loss, Sensorineural Clinical Trial

Official title:

Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01186185
• Other study ID #: IRB00006240
• Status: Terminated
• Phase: Early Phase 1
• Start date: August 2012
• Est. completion date: March 2016

Study information

• Verified date: October 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural

Intervention

Drug:
• Fludrocortisone
Fludrocortisone 0.2 mg by mouth daily for 30 days

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing	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.	At one month