Fludrocortisone for Sudden Hearing Loss

Oregon Health & Science University (OHSU)

Status and phase: Terminated; Early Phase 1

Conditions: Hearing Loss, Sensorineural

Treatments: Drug: Fludrocortisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01186185

IRB00006240

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

Fludrocortisone

Experimental group

Treatment:

Drug: Fludrocortisone