Status:
COMPLETED
Characterisation of the Nasal Microbiome in Patients With N-ERD
Lead Sponsor:
Medical University of Vienna
Conditions:
Aspirin Exacerbated Respiratory Disease
Chronic Rhinitis
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Chronic rhinosinusitis (CRS) with (w) and without (s) nasal polyps (NP) in its different shapes is currently affecting up to 16% of the total population of the United States and around 11% of the popu...
Detailed Description
Chronic rhinosinusitis (CRS) with (w) and without (s) nasal polyps (NP) in its different shapes is currently affecting up to 16% of the total population of the United States and around 11% of the popu...
Eligibility Criteria
Inclusion
- Male or Female
- Age: 18-90
- Willingness to participate in the study
- No use of nasal or systemic corticosteroids or immunosuppressants 2 weeks prior to their visit
- Patient groups:
- Control group: absence of any signs of acute or chronic rhinosinusitis
- CRS:
- CRSsNP CRSwNP N-ERD: N-ERD as previously confirmed by clinical history or provocation testing
- The presence of CRS will be confirmed by endoscopy (part of routine assessment at the ORL department, no study procedure) according to AAO-HNSF guidelines as follows :
- • Twelve weeks or longer of two or more of the following signs and symptoms:
- mucopurulent drainage (anterior, posterior, or both)
- nasal obstruction (congestion)
- facial pain-pressure-fullness, or
- decreased sense of smell
- AND inflammation is documented by one or more of the following findings:
- purulent (not clear) mucus or edema in the middle meatus or anterior ethmoid region
- polyps in nasal cavity or the middle meatus, and/or
- radiographic imaging showing inflammation of the paranasal sinuses
Exclusion
- Children
- Pregnant women (pregnancy test will be performed in women with child bearing potential)
- A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
- Use of nasal or systemic corticosteroids or immunosuppressants 2 weeks prior to their visit
- Patients with cystic fibrosis or immunosuppression.
- Severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity
Key Trial Info
Start Date :
January 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04375293
Start Date
January 7 2020
End Date
July 25 2021
Last Update
September 1 2021
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090