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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00956748
Recruitment Status : Not yet recruiting
First Posted : August 11, 2009
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Brian Westerberg, St. Paul's Hospital, Canada

Brief 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.

Condition or disease Intervention/treatment Phase
Otitis Media Otorrhea Drug: Ciprodex Drug: Ciprodex and 2% NAC Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media
Anticipated Study Start Date : June 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. cessation of otorrhea [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. durable cessation of otorrhea [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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

Additional relevant MeSH terms:
Otitis
Otitis Media
Suppuration
Otitis Media, Suppurative
Ear Diseases
Otorhinolaryngologic Diseases
Infection
Inflammation
Pathologic Processes
Dexamethasone acetate
Dexamethasone
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
Antiviral Agents