Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID05009758

Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps

Led by Medical University of Vienna · Updated on 2025-05-07

30

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Asthma and chronic rhinosinusitis (CRS) are inflammatory diseases affecting the respiratory tract, with asthma involving the lower airways and CRS the upper airways. These conditions may be connected as part of a "united airways" system, meaning inflammation in one area could impact the other. This study explores this connection by examining patients with asthma and CRS with nasal polyps, asthma and CRS without nasal polyps, and CRS with nasal polyps but without asthma, aiming to understand the disease mechanisms at cellular and molecular levels. Participants will be divided into three groups based on clinical assessments including lung function, blood eosinophil counts, and nasal polyp scores. The study involves collecting samples from the nose, oropharynx, and lungs through various procedures such as blood sampling, nasosorption, oral sampling, bronchoscopy with biopsies, nasal biopsies, and nasal mucosa mRNA sampling. Additional tests include pregnancy tests, smell tests, spirometry, FeNO measurement, and lung X-rays. These procedures will help characterize inflammatory profiles and local microbiomes across the different patient groups. During the study, participants will provide medical history and complete questionnaires assessing quality of life related to asthma and CRS. Researchers will monitor airway inflammation, immunological profiles, and microbiome compositions over two years. The primary outcome is the inflammatory profile in airway sections, with secondary outcomes including endotype characterization of CRS and microbiome analyses. Safety monitoring includes lung X-rays after bronchoscopy and follow-up in the pulmonology ward. The total study duration is up to two years, with ongoing assessments to better understand and guide treatment for united airway diseases.

CONDITIONS

Brief Title

Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 99 years
  • Clinical diagnosis of asthma (ICD-10 Code: J45)
  • Receiving moderate to severe asthma treatment (GINA/DAL step 4 or 5) without oral corticosteroids or monoclonal antibodies
  • Asthma treatment for at least 12 weeks before screening
  • For groups with T2-high asthma: FeNO > 25 ppB
  • Blood eosinophils ≥ 250 cells/µl measured twice or at least once at screening, or sputum eosinophils > 2% within last 12 months
  • Presence of chronic rhinosinusitis with nasal polyps (CRSwNP) confirmed by endoscopy or CT for groups with polyps
  • For group without asthma but with CRSwNP: evidence of Type 2 inflammation (blood eosinophils ≥ 250 cells/µl or total IgE > 100 kU/L)
  • Absence of asthma and NSAID-exacerbated respiratory disease (N-ERD) for CRSwNP without asthma group
  • At least 3 months washout period after monoclonal antibody treatment for asthma or polyps
Not Eligible

You will not qualify if you...

  • Pregnancy as determined by beta-HCG test
  • Severe anatomical nasal variations preventing access to nasal cavity areas
  • Chronic oral corticosteroid therapy
  • Other lung disorders such as bronchiectasis, COPD, pulmonary fibrosis, emphysema, primary ciliary dyskinesia, cystic fibrosis, parasitic infections, or lung cancer
  • Pulmonary conditions with asthma-like symptoms and blood eosinophilia (EGPA, allergic bronchopulmonary aspergillus, hypereosinophilic syndrome)
  • Mental conditions impairing understanding of the study
  • Clinically significant comorbidities
  • Exacerbation of chronic rhinosinusitis or asthma within 4 weeks before any visit
  • Systemic corticosteroid bursts within 4 weeks before any visit
  • Immunosuppressive treatments like cyclosporine
  • Drug or alcohol abuse
  • Current smokers
  • Former smokers who quit less than 6 months ago or with more than 10 pack-years smoking history

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Surveillance

Duration - Up to 2 years

Participants undergo detailed evaluation of inflammatory profiles and immunological status through various biological sample collections and assessments.

1 visit involving multiple sample collections and tests (in-person)

Trial Site Locations

Total: 1 location

1

Allgemeines Krankenhaus (AKH) Wien

Vienna, Austria, 1090

Actively Recruiting

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Research Team

J

Julia Eckl-Dorna, PhD

S

Sven Schneider, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

SCREENING

Number of Arms

3

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Published Research Related To This Trial

Prevalence of asthma, aspirin sensitivity and allergy in chronic rhinosinusitis: data from the UK National Chronic Rhinosinusitis Epidemiology Study.

Carl M Philpott, Sally Erskine, Claire Hopkins...

https://pubmed.ncbi.nlm.nih.gov/29945606