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The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity

This study is currently recruiting participants.
Verified November 2008 by University of Chicago
Sponsor:
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00790972
First received: November 13, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.


Condition Intervention
MRSA Infection
 Drug: Sinofresh
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 2
Identical-appearing placebo
 Drug: Placebo
two sprays in each nostril three times daily for one week
Active Comparator: 1
two sprays in each nostril three times daily for one week
 Drug: Sinofresh
two sprays in each nostril three times daily for one week

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • The volunteer is able to adhere to the study requirements and study visits.
  • Agrees to abstain from use of other nasal sprays for length of study.
  • Diagnosis of an MRSA carrier by PCR testing

Exclusion Criteria:

  • History of chronic nose bleeds.
  • History of intranasal steroids in the last 2 months
  • Nasal obstruction severe enough to prohibit effective delivery of a nasal spray
  • Epistaxis
  • Significant excoriation in the opinion of the Investigator.
  • Known hypersensitivity to any ingredients
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00790972

Contacts
Contact: Irsk Anderson 773-702-6840 ianderso@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Irsk Anderson, MD     773-702-6840     ianderso@medicine.bsd.uchicago.edu    
Principal Investigator: Irsk Anderson, MD            
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Irsk Anderson, MD University of Chicago
  More Information

No publications provided

Responsible Party: Irsk Anderson, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT00790972     History of Changes
Other Study ID Numbers: 15419A
Study First Received: November 13, 2008
Last Updated: November 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
MRSA
sinofresh
nasal spray

Additional relevant MeSH terms:
Staphylococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Ephedrine
Pseudoephedrine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
 Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Respiratory System Agents
Bronchodilator Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on May 22, 2013