Fludrocortisone for Sudden Hearing Loss

• Status: Terminated
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oregon Health and Science University
• Treatments: Fludrocortisone; Mineralocorticoids

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