Characterisation of Nasal Polyps in Patients With and Without Aspirin-exacerbated Respiratory Disease

NCT03848156 | Completed

• 1 other identifier: AERD2019
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Prevalence of aspirin-exacerbated respiratory disease (AERD) is 16% amongst patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). The mechanisms underlying the observed dysregulation of pro and anti-inflammatory pathways in AERD are still not fully understood. To address this and also to identify potential factors characterizing the disease the investigators plan to prospectively collect blood samples, nasal secretions as well as nasal biopsies from allergic, non-allergic and AERD patients suffering from CRSwNP. Initially, polyps of aforementioned patients will be subjected to RNA sequencing analysis using microarray technology. Once distinct factors are identified in nasal polyp tissue, their presence will be assessed in nasal secretions and serum of the respective patients to investigate their potential role as biomarkers. Furthermore presence of these parameters will be confirmed in situ in biopsies by confocal microscopy. Knowledge about factors differently upregulated in polyp tissue from AERD may contribute to a better understanding of the underlying mechanism of the disease.

Conditions

Polyp Sinus

Outcome Measures

Primary Outcomes (1)

• RNA Sequencing of polyps using Illumina platform

  Differences in expression patterns in RNA expression in the 4 groups assessed using Illumina platform for RNA sequencing

  patients will be recruited over the course of one year until 20 patients have been reached. Each patient will be sequenced when the sample is received.

Study Arms (4)

CRSwNP AERD allergic

Patients suffering from chronic rhinosinusitis with nasal polyps, allergy and aspirin exacerbated respiratory disease - biopsy for RNA sequencing

Other: biopsy

CRSwNP AERD non-allergic

Patients suffering from chronic rhinosinusitis with nasal polyps without allergy and aspirin exacerbated respiratory disease - biopsy for RNA sequencing

Other: biopsy

CRSwNP non-allergic

Patients suffering from chronic rhinosinusitis with nasal polyps without allergy - biopsy for RNA sequencing

Other: biopsy

CRSwNP allergic

Patients suffering from chronic rhinosinusitis with nasal polyps with allergy - biopsy for RNA sequencing

Other: biopsy

Interventions

biopsy OTHER

Biopsy of nasal polyp for RNA sequencing

CRSwNP AERD allergic; CRSwNP AERD non-allergic; CRSwNP allergic; CRSwNP non-allergic

Eligibility Criteria

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

Study Population

Patients suffering from chronic rhinosinusitis with nasal polyps with/without AERD and with/without allergy

You may qualify if:

• Male or Female
• Age: 18-90
• Willingness to participate in the study
• Suffering from CRSwNP (with or without prior history of surgery for nasal polyposis)
• Allergic or non-allergic: if no recent allergy test is available (max. two years old) the presence or absence of allergy will be determined by skin prick test and by ImmunoCAP for allergen-specific serum immunoglobulin E (IgE) levels in addition to assessment of patients's history by questionnaire.
• Suffering from AERD or not as confirmed by provocation testing

You may not qualify if:

• Children
• Pregnant women - the presence of a known pregnancy will be assessed during the visit by questionnaire
• A mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study

Sponsors & Collaborators

• Medical University of Vienna: lead
• AstraZeneca: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITH DNA

Polyp biopsy, blood, nasal secretion

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 20, 2019
• Study Start: February 12, 2019
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Locations

AU (1)