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NCT Number: NCT01553110

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Nasal Secretion Collection

    Time frame: 10 minutes

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

Secondary outcomes

  1. Subjective nasal scoring

    Time frame: 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.

  2. Nasal Volume

    Time frame: 15 Minutes

    Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2018
Study completion
2019
First posted
Mar 13, 2012
Registry last updated
Apr 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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