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

May 19, 2016 updated by: University of Chicago
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Irsk Anderson, MD, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Anticipated)

June 1, 2010

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Estimate)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 19, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15419A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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