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

This study is currently recruiting participants.

Verified by University of Chicago, November 2008

First Received: November 13, 2008 No Changes Posted

Sponsored by:	University of Chicago
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00790972

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:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity

Resource links provided by NLM:

Drug Information available for: Ephedrine Hydrochloride Ephedrine Pseudoephedrine hydrochloride Pseudoephedrine Sulfate

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
2: Placebo Comparator Identical-appearing placebo	Drug: Placebo two sprays in each nostril three times daily for one week
1: Active Comparator 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:	University of Chicago ( Irsk Anderson, MD )
Study ID Numbers:	15419A
Study First Received:	November 13, 2008
Last Updated:	November 13, 2008
ClinicalTrials.gov Identifier:	NCT00790972 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Chicago:

MRSA
sinofresh
nasal spray

Study placed in the following topic categories:

Pseudoephedrine
Neurotransmitter Agents
Adrenergic Agents
Anti-Asthmatic Agents
Central Nervous System Stimulants
Cardiovascular Agents
Nasal Decongestants

Oxymetazoline
Phenylephrine
Vasoconstrictor Agents
Ephedrine
Peripheral Nervous System Agents
Bronchodilator Agents

Additional relevant MeSH terms:

Pseudoephedrine
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Central Nervous System Stimulants
Cardiovascular Agents

Infection
Pharmacologic Actions
Nasal Decongestants
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Ephedrine
Peripheral Nervous System Agents
Bronchodilator Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 10, 2009