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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by St. Paul's Hospital, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
St. Paul's Hospital, Canada
ClinicalTrials.gov Identifier:
NCT00956748
First received: August 7, 2009
Last updated: August 10, 2009
Last verified: August 2009
History of Changes
  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:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

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: October 2009
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: April 2011 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956748

Contacts
Contact: John Phillips, MD 604-806-8540 john.phillips@mac.com
Contact: Helen Jiang, B.Sc 604-782-3900 heljiang@gmail.com

Locations
Canada, British Columbia
St. Paul's Hospital Rotary Hearing Clinic Not yet recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
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. Westerberg, Brian D., St. Paul's Hospital Rotary Hearing Clinic
ClinicalTrials.gov Identifier: NCT00956748     History of Changes
Other Study ID Numbers: H09-00953
Study First Received: August 7, 2009
Last Updated: August 10, 2009
Health Authority: Canada: Health Canada

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
Acetylcysteine
Ciprofloxacin
N-monoacetylcystine
BB 1101
Dexamethasone acetate
Dexamethasone
 Dexamethasone 21-phosphate
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013