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

Status: Withdrawn
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
St. Paul's Hospital BC Rotary Hearing & Balance Centre
Vancouver
Time Frame
Start Date: 2019-11-29
Completion Date: 2019-11-29
Treatments
Active_comparator: Ciprodex otic solution
ciprofloxacin 0.3% / dexamethasone 0.1% otic solution
Experimental: Ciprodex with 2% NAC
Ciprodex otic solution (ciprofloxacin 0.3% / dexamethasone 0.1%) augmented with 2% N-acetylcysteine
Related Therapeutic Areas
Sponsors
Leads: St. Paul's Hospital, Canada

This content was sourced from clinicaltrials.gov