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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790972
Recruitment Status : Withdrawn (Company went out of business.)
First Posted : November 14, 2008
Last Update Posted : May 20, 2016
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
MRSA Infection Drug: Sinofresh Drug: Placebo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity
Study Start Date : June 2007
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : June 2013
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00790972


Locations
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United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Irsk Anderson, MD University of Chicago
More Information
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00790972    
Other Study ID Numbers: 15419A
First Posted: November 14, 2008    Key Record Dates
Last Update Posted: May 20, 2016
Last Verified: May 2016
Keywords provided by University of Chicago:
MRSA
sinofresh
nasal spray