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

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553110
• Other study ID #: HM14200
• Status: Completed
• Start date: March 2012
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Rhinosinusitis
• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Sinusitis

Locations

Country	Name	City	State
United States	Virginia Commonwealth University School of Medicine	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Secretion Collection	To measure the biophysical properties of nasal secretions for improved mucus clearance.	10 minutes
Secondary	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
Secondary	Nasal Volume	Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.	15 Minutes