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An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms

This study is currently recruiting participants.
Verified February 2017 by Virginia Commonwealth University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01553110
First Posted: March 13, 2012
Last Update Posted: February 23, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
This is a study to learn more about the common cold from studying the nasal secretions produced during a cold or episode of allergic rhinitis.

Condition
Acute Rhinosinusitis Allergic Rhinitis

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms in Acute Rhinosinusitis.

Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Nasal Secretion Collection [ Time Frame: 10 minutes ]
    To measure the biophysical properties of nasal secretions for improved mucus clearance.


Secondary Outcome Measures:
  • Subjective nasal scoring [ Time Frame: 10 Minutes ]
    The Sinus and Nasal Quality of Life Survey (SN-20) questionnaire assess the impact of infection on nasal symptoms, emotion, and activity on a scale of worsening symptoms scored 1 through 7 to provide a quantifiable score capable of comparing both disease severity and the impact of interventions on subjective complaints.

  • Nasal Volume [ Time Frame: 15 Minutes ]
    Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.


Biospecimen Retention:   Samples With DNA
Nasal Secretions

Estimated Enrollment: 62
Study Start Date: March 2012
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cold Population
Male and female subjects 12 years of age and older with acute nasal discharge fewer then 7 days. Patients must be symptomatic at screening.
Allergic Rhinitis
Male and female subjects of 12 years of age and older with a history suggesting nasal allergic symptoms for at least 1 year. Patients must be symptomatic at screening.

Detailed Description:
This study involves collecting and analyzing nasal mucus to see if there are changes in mucus properties during the course of a cold or episode of allergic rhinitis. Outcome measures include SNOT20 questionnaire, nasal secretion collection, acoustic rhinometry on the fifth and fourteenth day of symptoms. The investigators will also collect SNOT20 questionnaires on the tenth and twenty-eighth day.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinics and Community
Criteria

Inclusion Criteria:

  • Male and female subjects 12 years of age and older with acute nasal discharge fewer than 7 days or a history suggesting nasal allergic symptoms for at least 1 year. Internet access required during the course of the study. Patients must be symptomatic at screening.

Exclusion Criteria:

  • Symptoms suggesting bacterial rhinosinusitis such as fever ≥ 101ºF/38.3ºC, facial swelling, and serve tooth pain. History of CRS or sinus/nasal surgery for this condition within 6 months before screening. History of respiratory signs and symptoms due to allergic rhinitis. Therapy with bronchodilators, nasal steroids, oral corticosteroids in the past 30 days. Therapy with antihistamines, nasal (Neti) washings, or decongestants in the past 24 hours. Use of any OTC cold or allergy medication 24 hours before study visits requires a 24 hour washout phase
  Contacts and Locations
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): NCT01553110


Contacts
Contact: Meg Lessard, B.S. 804-628-3093 margaret.lessard@vcuhealth.org

Locations
United States, Virginia
Virginia Commonwealth University School of Medicine Recruiting
Richmond, Virginia, United States, 23298
Contact: Grace H. Henderson, B.S.    804-628-5875    grace.henderson@vcuhealth.org   
Principal Investigator: Bruce K Rubin, MEngr, MD, MBA, FRCPC         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Bruce K Rubin, MEngr, MD, MBA, FRCPC Virginia Commonwealth University School of Medicine
Study Director: Melissa A Yopp, M.S.H.A Virginia Commonwealth University School of Medicine
  More Information

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01553110     History of Changes
Other Study ID Numbers: HM14200
First Submitted: March 6, 2012
First Posted: March 13, 2012
Last Update Posted: February 23, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Virginia Commonwealth University:
Cold
Acute Rhinosinusitis
Allergic Rhinitis

Additional relevant MeSH terms:
Nose Diseases
Rhinitis
Rhinitis, Allergic
Sinusitis
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Paranasal Sinus Diseases