Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)NCT03975842
Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps
An observational study of Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP), run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
- What is being tested?
- Sinonasal and otologic evaluation
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Dec 2012
- 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 15 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)
Who may be able to join
- 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
Who cannot join
- Presence of a mucopurulent discharge or granuloma during endoscopic nasal examination
About this study
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.
- Being tested
- Sinonasal and otologic evaluation
- Keywords
- otitis media with effusion (OME), prevalence, risk factor, endoscopic nasal examination, otoscopic examination, pure-tone audiometry, tympanometry
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinonasal and otologic evaluationOther
At onset, each participant had:
- sinonasal evaluation (several nasal signs and symptoms were evaluated, bilateral endoscopic nasal examination, computed tomography (CT) of the sinuses when sinus surgery became necessary).
- otologic evaluation (evaluation of middle ear status, documentations of personal history of otologic disease, otoscopic examination, pure-tone audiometry and tympanometry)
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of OME in CRSwNP patients.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975842
- Sponsor's protocol ID
- 30138520
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Otitis Media With Effusion in Chronic Sinusitis With Polyps
- ClinicalTrials.gov ID
- NCT03975842
- Acronym / sponsor ID
- 30138520
- Keywords
- otitis media with effusion (OME), prevalence, risk factor, endoscopic nasal examination, otoscopic examination, pure-tone audiometry, tympanometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 5 Jun 2019 (actual)
- 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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic rhinosinusitis with nasal polyposis (CRSwNP)
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Presence of a mucopurulent discharge or granuloma during endoscopic nasal examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinonasal and otologic evaluationAt onset, each participant had: * sinonasal evaluation (several nasal signs and symptoms were evaluated, bilateral endoscopic nasal examination, computed tomography (CT) of the sinuses when sinus surgery became necessary). * otologic evaluation (evaluation of middle ear status, documentations of personal history of otologic disease, otoscopic examination, pure-tone audiometry and tympanometry) | Other | – |
Primary outcome
The prevalence of OME in CRSwNP patients.
Time frame: 2 years
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 5 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP), run by Fondation Ophtalmologique Adolphe de Rothschild.
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 2 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 5 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The prevalence of OME in CRSwNP patients. (time frame: 2 years). 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 5 Jun 2019; AzTrials last refreshed its copy on 26 Oct 2026.