Fludrocortisone for Sudden Hearing Loss

Stopped early · Early Phase 1

Conditions studied: Hearing Loss, Sensorineural

In brief

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.

Key facts

Study ID

NCT01186185

Run by

Oregon Health and Science University

People needed

5

Starts

2012-08-01

Expected to finish

2016-03-01

Last updated by the study team

2019-10-18

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Oregon Health & Science University — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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