FST-201 In The Treatment of Acute Fungal Otitis Externa

A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension in Subjects With Acute Fungal Otitis Externa

The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the treatment of acute fungal otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute fungal otitis externa.

Study Overview

• Status: Terminated
• Conditions: Acute Fungal Otitis Externa
• Intervention / Treatment: Drug: FST-201 (dexamethasone 0.1%) Otic Suspension; Drug: Vehicle

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • ENT Associates of South Florida
    • Sarasota, Florida, United States, 34239
  • Texas
    • Austin, Texas, United States, 78705
      • Austin Ear, Nose, and Throat Clinic
    • San Antonio, Texas, United States, 78215
      • San Antonio Ear, Nose, and Throat Research
    • San Antonio, Texas, United States, 78229
      • San Antonio Ear, Nose, and Throat Research
    • San Antonio, Texas, United States, 78258
      • Ear Institute of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have a clinical diagnosis of AFOE of in one or both ears, based on a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1) and/or 1 for pruritis (absent = 0, present = 1)
• Have appearance consistent with fungal debris, i.e. white or black appearance consistent with Aspergillus spp. or Candida spp.
• Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race
• Provide written informed consent
• Be willing and able to follow all instructions and attend all study visits
• If female and of child bearing potential, agree to and submit a urine sample for pregnancy testing at Visit 1 and upon their exit from the study. Post menopausal is defined as having no menses for 12 consecutive months.

Exclusion Criteria:

• Have known sensitivity to any component of the study medications
• Have a current infection requiring systemic antimicrobial treatment
• Take any systemic (within 30 days) or otic corticosteroids (within 1 day) prior to Visit 1
• Have used topical or systemic anti-inflammatory agents on the same day as Visit 1 and for the duration of the study
• Have used topical or systemic pain medications on the same day as Visit 1 and for the duration of the study
• Have used any topical otic treatment within 1 days prior to Visit 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FST-201 (dexamethasone 0.1%) Otic Suspension	Drug: FST-201 (dexamethasone 0.1%) Otic Suspension; Instill four drops times two times a day.
Placebo Comparator: vehicle	Drug: Vehicle; Instill four times two times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge.	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Microbiological resolution defined as absence of pre-treatment pathogenic fungal species.	1 year

Collaborators and Investigators

• Sponsor: Shire

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2009
• Primary Completion (Actual): July 31, 2010
• Study Completion (Actual): July 31, 2010

Study Registration Dates

• First Submitted: July 23, 2009
• First Submitted That Met QC Criteria: July 23, 2009
• First Posted (Estimate): July 24, 2009

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 24, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Bacterial Infections and Mycoses; Ear Diseases; Mycoses; Otitis Externa; Otitis; Otomycosis; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: FST201-AFOE-02