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

NCT ID: NCT01553110

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2019-04-30

Brief Summary

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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

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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.

Conditions

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Acute Rhinosinusitis Allergic Rhinitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruce K Rubin, MEngr, MD, MBA, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University School of Medicine

Melissa A Yopp, M.S.H.A

Role: STUDY_DIRECTOR

Virginia Commonwealth University School of Medicine

Locations

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Virginia Commonwealth University School of Medicine

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HM14200

Identifier Type: -

Identifier Source: org_study_id

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