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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