- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03975842
Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps
June 4, 2019 updated by: Fondation Ophtalmologique Adolphe de Rothschild
The relationship between otitis media with effusion (OME) and chronic rhinosinusitis with nasal polyposis (CRSwNP) remains unclear.
A cross-sectional study of 80 consecutively presenting patients who were diagnosed with CRSwNP was conducted.
The aim was to ascertain the prevalence of OME in CRSwNP patients, to determine whether the severity of CRSwNP affected OME, and to identify risk factors for OME in CRSwNP patients.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
80
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)
Description
Inclusion Criteria:
- Patients over 15 years of age
- Presence of chronic rhinosinusitis with nasal polyposis (CRSwNP) previously diagnosed or diagnosed at study's onset by endoscopic nasal examination
Exclusion Criteria:
- Presence of a mucopurulent discharge or granuloma during endoscopic nasal examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The prevalence of OME in CRSwNP patients.
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2010
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
June 4, 2019
First Submitted That Met QC Criteria
June 4, 2019
First Posted (Actual)
June 5, 2019
Study Record Updates
Last Update Posted (Actual)
June 5, 2019
Last Update Submitted That Met QC Criteria
June 4, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30138520
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
-
GB001, Inc, a wholly owned subsidiary of Gossamer...CompletedChronic Rhinosinusitis Without Nasal Polyps (CRSsNP) | Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)United States, Czechia, Ukraine
-
The First Affiliated Hospital with Nanjing Medical...Not yet recruitingChronic Rhinosinusitis With Nasal Polyps (CRSwNP)
-
SanofiRegeneron PharmaceuticalsCompletedChronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)Belgium, Mexico, Turkey, Israel, Spain, Sweden, Argentina, Canada, Japan, United States, Australia, Chile, Portugal, Russian Federation
-
SanofiRegeneron PharmaceuticalsCompletedChronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)Italy, Ukraine, Hungary, United States, Bulgaria, Czechia, France, Germany, Netherlands, Poland, Romania, Russian Federation, United Kingdom
-
Keymed Biosciences Co.LtdNot yet recruitingChronic Rhinosinusitis With Nasal Polyposis
-
Christiane HaaseActive, not recruitingAsthma | Chronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsDenmark
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Regeneron PharmaceuticalsSanofiRecruitingChronic Rhinosinusitis With Nasal PolyposisUnited States, Italy, Canada, Japan, Germany, Netherlands
-
Ohio State UniversityActive, not recruitingChronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsUnited States
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St. Paul's Sinus CentreRecruitingAsthma | Chronic Rhinosinusitis With Nasal Polyps | Chronic Rhinosinusitis Without Nasal PolypsCanada
-
Johns Hopkins UniversityGlaxoSmithKlineRecruitingChronic Rhinosinusitis (Diagnosis) | Chronic Rhinosinusitis With Nasal PolypsUnited States
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