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

Completed

• Conditions: Acute Rhinosinusitis; Allergic Rhinitis

• Registration Number: NCT01553110
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

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 Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-06
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Primary Completion: 2018-12
• Status Verified: 2019-04
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-24
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Nasal Secretion Collection	10 minutes	To measure the biophysical properties of nasal secretions for improved mucus clearance.

Secondary Outcome Measures

Name	Time	Method
Subjective nasal scoring	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	15 Minutes	Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.

Trial Locations

Locations (1)

Virginia Commonwealth University School of Medicine; 🇺🇸 Richmond, Virginia, United States