The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in
the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug
Application in support of FST-201 for the indication of acute otitis externa.
N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media
Withdrawn
St. Paul's Hospital, Canada
Phase 4
2019-11-29
Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of
patients do not respond to routine antibiotic or surgical treatments. The current treatment
involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex
(ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of
symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that
the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis
media with effusion compared to the use of Ciprodex alone.
The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in
the treatment of acute otitis externa. This study will be conducted at one site, the Lyndon
B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago,
American Samoa.
In this multi-center phase III trial, untreated patients diagnosed with AL who are not
candidates for stem cell transplant with melphalan 200 mg/m2 are the target population. Stage
I and II patients will be eligible. Stage III patients will be enrolled in an ancillary phase
II study. Eligible patients will be stratified as cardiac stage I or stage II and then
randomized to receive MDex or BMDex.
Primary objective is to compare hematologic(clonal) response i.e. the rate of complete
response (CR) + partial response (PR) defined according to the criteria of the International
Society for Amyloidosis consensus.
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