NCT00790972

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

May 20, 2016

Status Verified

May 1, 2016

Enrollment Period

3 years

First QC Date

November 13, 2008

Last Update Submit

May 19, 2016

Conditions

MRSA Infection

Keywords

MRSAsinofreshnasal spray

Outcome Measures

Primary Outcomes (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.

    7 days

Study Arms (2)

2

PLACEBO COMPARATOR

Identical-appearing placebo

Drug: Placebo

1

ACTIVE COMPARATOR

two sprays in each nostril three times daily for one week

Drug: Sinofresh

Interventions

SinofreshDRUG

two sprays in each nostril three times daily for one week

1
PlaceboDRUG

two sprays in each nostril three times daily for one week

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Study Officials

  • Irsk Anderson, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 14, 2008

Study Start

June 1, 2007

Primary Completion

June 1, 2010

Study Completion

June 1, 2013

Last Updated

May 20, 2016

Record last verified: 2016-05

Locations

US(1)