Acute RhinosinusitisNCT01553110
An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms
An observational study of Acute Rhinosinusitis and Allergic Rhinitis, run by Virginia Commonwealth University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Acute Rhinosinusitis, Allergic Rhinitis
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary Care Clinics and Community
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University School of Medicine
Richmond, Virginia, 23298
About this study
Official title: An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms in Acute Rhinosinusitis.
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.
Read the 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.
- Conditions
- Acute Rhinosinusitis, Allergic Rhinitis
- Keywords
- Cold, Acute Rhinosinusitis, Allergic Rhinitis
- Medical subject headings
- Rhinitis, Allergic, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Secretion Collection
To measure the biophysical properties of nasal secretions for improved mucus clearance.
Measured: 10 minutes
Secondary outcomes (2)
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.
Measured: 10 Minutes
Nasal Volume
Acoustic rhinometry is used to measure cross-sectional volume of the nasal cavity allowing the calculation of nasal volume.
Measured: 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionDec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruce K Rubin, MEngr, MD, MBA, FRCPC, Principal investigator, Virginia Commonwealth University School of MedicineMelissa A Yopp, M.S.H.A, Study director, Virginia Commonwealth University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01553110
- Sponsor's protocol ID
- HM14200
- Status last verified
- Apr 2019
- First submitted
- 6 Mar 2012
- Last updated
- 25 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Evaluate The Relationship of Nasal Mucus Properties and Symptoms in Acute Rhinosinusitis.
- ClinicalTrials.gov ID
- NCT01553110
- Acronym / sponsor ID
- HM14200
- Conditions
- Acute Rhinosinusitis, Allergic Rhinitis
- Keywords
- Cold, Acute Rhinosinusitis, Allergic Rhinitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary Care Clinics and Community
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nasal Secretion Collection
Time frame: 10 minutes
To measure the biophysical properties of nasal secretions for improved mucus clearance.
2 secondary outcomes
Subjective nasal scoring
Time frame: 10 Minutes
Nasal Volume
Time frame: 15 Minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce K Rubin, MEngr, MD, MBA, FRCPC principal investigator
Virginia Commonwealth University School of Medicine
Melissa A Yopp, M.S.H.A study director
Virginia Commonwealth University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Rhinosinusitis and Allergic Rhinitis, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Secretion Collection (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2019.