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

NCT01553110 | Completed DMC

• 1 other identifier: HM14200
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Rhinosinusitis; Allergic Rhinitis

Keywords

Cold; Acute Rhinosinusitis; Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Nasal Secretion Collection

  To measure the biophysical properties of nasal secretions for improved mucus clearance.

  10 minutes

Secondary Outcomes (2)

• Subjective nasal scoring

  10 Minutes

• Nasal Volume

  15 Minutes

Study Arms (2)

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.

Eligibility Criteria

• Age: 12 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary Care Clinics and Community

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University School of Medicine

Richmond, Virginia, 23298, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal Secretions

MeSH Terms

Conditions

Rhinitis, Allergic; Common Cold

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Study Officials

• Bruce K Rubin, MEngr, MD, MBA, FRCPC

  Virginia Commonwealth University School of Medicine

  PRINCIPAL INVESTIGATOR

• Melissa A Yopp, M.S.H.A

  Virginia Commonwealth University School of Medicine

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 13, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2018
• Study Completion: April 1, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Locations

US (1)