Characterisation of the Nasal Microbiome in Patients With N-ERD

NCT04375293 | Completed

• 1 other identifier: MicroNERD
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 population in Europe. It may also be associated with a hypersensitivity to non-steroidal anti-inflammatory (NSAID) drugs in a syndrome called NSAID-exacerbated respiratory disease (N-ERD) characterized by highly recurrent polyps and concomitant asthma. The pathophysiological mechanisms especially with regards to the potential role of the microbiome in driving N-ERD are so far not fully understood. Here, the investigators plan to analyse the nasal microbiome in these patients and to compare it to nasal samples from CRSwNP and CRSsNP patients as well as healthy controls (in total 80 subjects). This will provide insights into potential differences in the microbiome as compared to other CRS patients and the impact of the microbiome in driving this disease.

Conditions

Aspirin Exacerbated Respiratory Disease; Chronic Rhinitis

Keywords

aerd, microbiome

Outcome Measures

Primary Outcomes (1)

• Nasal microbiome

  Differences in microbial community composition between patients with N-ERD, CRSsNP, CRSwNP and healthy controls will be determined by 16S rRNA gene amplicon sequencing

  1 year

Study Arms (4)

AERD

EXPERIMENTAL

Patients suffering from AERD

Other: Microbiome swabs

Healthy

SHAM COMPARATOR

Healthy Controls

Other: Microbiome swabs

CRSwNP

ACTIVE COMPARATOR

Patients suffering from CRS with nasal polyps

Other: Microbiome swabs

CRSsNP

ACTIVE COMPARATOR

Patients suffering from CRS without nasal polyps

Other: Microbiome swabs

Interventions

Microbiome swabs OTHER

Swabs for analysis of microbiome

AERD; CRSsNP; CRSwNP; Healthy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: May 5, 2020
• Study Start: January 7, 2020
• Primary Completion: July 25, 2021
• Study Completion: July 25, 2021
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)