FST-201 In The Treatment of Acute Fungal Otitis Externa

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Acute Fungal Otitis Externa	Drug: FST-201 (dexamethasone 0.1%) Otic Suspension; Drug: Vehicle	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	6 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	July 2009
Actual Primary Completion Date :	July 2010
Actual Study Completion Date :	July 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Microbiological resolution defined as absence of pre-treatment pathogenic fungal species. [ Time Frame: 1 year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Shire

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT00945646 History of Changes
Other Study ID Numbers:	FST201-AFOE-02
First Posted:	July 24, 2009
Last Update Posted:	September 30, 2015
Last Verified:	September 2012

Additional relevant MeSH terms:

Otitis; Otitis Externa; Otomycosis; Ear Diseases; Otorhinolaryngologic Diseases; Mycoses; Dexamethasone acetate; Dexamethasone; BB 1101; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents	Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action