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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01553110
First received: March 6, 2012
Last updated: April 10, 2014
Last verified: April 2014
  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 ] [ Designated as safety issue: No ]
    To measure the biophysical properties of nasal secretions for improved mucus clearance.


Secondary Outcome Measures:
  • Subjective nasal scoring [ Time Frame: 10 Minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 2014
Estimated Primary Completion Date: November 2014 (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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01553110

Locations
United States, Virginia
Virginia Commonwealth University School of Medicine Recruiting
Richmond, Virginia, United States, 23298
Contact: Jennifer L Bradley, B.A.    (804) 628-2793    jlbradley@vcu.edu   
Principal Investigator: Bruce K Rubin, MEngr, MD, MBA, FRCPC         
Principal Investigator: Melissa A Yopp, BS         
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

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01553110     History of Changes
Other Study ID Numbers: HM14200
Study First Received: March 6, 2012
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014