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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2016 by St. Paul's Hospital, Canada
Sponsor:
Information provided by (Responsible Party):
Dr Brian Westerberg, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00956748
First received: August 7, 2009
Last updated: April 13, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Otitis Media
Otorrhea
Drug: Ciprodex
Drug: Ciprodex and 2% NAC
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media

Resource links provided by NLM:


Further study details as provided by St. Paul's Hospital, Canada:

Primary Outcome Measures:
  • cessation of otorrhea [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • durable cessation of otorrhea [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ciprodex otic solution
ciprofloxacin 0.3% / dexamethasone 0.1% otic solution
Drug: Ciprodex
Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists.
Other Name: ciprofloxacin 0.3% / dexamethasone 0.1%
Experimental: Ciprodex with 2% NAC
Ciprodex otic solution (ciprofloxacin 0.3% / dexamethasone 0.1%) augmented with 2% N-acetylcysteine
Drug: Ciprodex and 2% NAC
Administer 3 to 5 drops tid for 14 days. Continue treatment for another 14 days if otorrhea persists.
Other Name: Ciprodex with 2% N-Acetylcysteine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956748

Contacts
Contact: Rochelle Galleto, LPN 604-682-2344 ext 64217 rgalleto@providencehealth.bc.ca

Locations
Canada, British Columbia
St. Paul's Hospital BC Rotary Hearing & Balance Centre Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: Rochelle Galleto, LPN    604-682-2344 ext 64217    rgalleto@providencehealth.bc.ca   
Principal Investigator: Brian D Westerberg, MD         
Sponsors and Collaborators
St. Paul's Hospital, Canada
Investigators
Principal Investigator: Brian D Westerberg, MD St. Paul's Hospital Rotary Hearing Clinic
  More Information

Publications:
Responsible Party: Dr Brian Westerberg, Clinical Professor, Department of Surgery, UBC Otology & Neurotology, St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier: NCT00956748     History of Changes
Other Study ID Numbers: H09-00953 
Study First Received: August 7, 2009
Last Updated: April 13, 2016
Health Authority: Canada: Health Canada
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by St. Paul's Hospital, Canada:
chronic suppurative otitis media with persistent otorrhea

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media, Suppurative
Suppuration
Ear Diseases
Otorhinolaryngologic Diseases
Infection
Inflammation
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Ciprofloxacin
BB 1101
Acetylcysteine
N-monoacetylcystine
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

ClinicalTrials.gov processed this record on July 28, 2016