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Fludrocortisone for Sudden Hearing Loss

Primary Purpose

Hearing Loss, Sensorineural

Status

Terminated

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Fludrocortisone

About this trial

This is an interventional treatment trial for Hearing Loss, Sensorineural focused on measuring sudden, sensorineural, hearing loss, fludrocortisone, mineralocorticoid, steroid

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Oregon Health & Science University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fludrocortisone

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01186185

First Posted

August 19, 2010

Last Updated

October 15, 2019

Sponsor

Oregon Health and Science University

1. Study Identification

Unique Protocol Identification Number

NCT01186185

Brief Title

Fludrocortisone for Sudden Hearing Loss

Official Title

Mineralocorticoid Treatment for Sudden Sensorineural Hearing Loss

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Terminated

Why Stopped

PI moved to new institution, unable to complete study

Study Start Date

August 2012 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hearing Loss, Sensorineural

Keywords

sudden, sensorineural, hearing loss, fludrocortisone, mineralocorticoid, steroid

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fludrocortisone

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fludrocortisone

Intervention Description

Fludrocortisone 0.2 mg by mouth daily for 30 days

Primary Outcome Measure Information:

Title

Hearing

Description

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.

Time Frame

At one month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anh Nguyen-Huynh, MD PhD

Organizational Affiliation

Oregon Health and Science University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oregon Health & Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Fludrocortisone for Sudden Hearing Loss

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