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

An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms in Acute Rhinosinusitis.

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis; Acute Rhinosinusitis

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.

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinics and Community

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Secretion Collection	To measure the biophysical properties of nasal secretions for improved mucus clearance.	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nasal Volume	Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.	15 Minutes
Subjective nasal scoring	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.	10 Minutes

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: March 6, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Actual): April 25, 2019
• Last Update Submitted That Met QC Criteria: April 24, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Allergic Rhinitis; Cold; Acute Rhinosinusitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: HM14200

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No