N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media

• Status: Withdrawn
• Trial end date: 2019-11-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Paul's Hospital, Canada
• Treatments: Acetylcysteine; BB 1101; Ciprofloxacin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; N-monoacetylcystine

Criteria

Inclusion Criteria:

• continuous otorrhea for a duration of greater than 6 months

• at least 2 previous treatment regimes for otitis media, which may include topical or oral antibiotics, myringotomy or tympanostomy, and surgery

Exclusion Criteria:

• existing cholesteatoma

• known allergy to ciprofloxacin, dexamethasone, or N-acetylcysteine

• patients who are unlikely to adhere to the treatment regime and follow-up visits