What is this study trying to find out about asthma and chronic rhinosinusitis?

This study aims to understand how asthma and chronic rhinosinusitis with or without nasal polyps are connected at a cellular and molecular level. Researchers are examining inflammatory patterns and local microbiomes to explore the concept of "united airways". The study is led by the Medical University of Vienna to improve treatment guidance for these conditions.

Who may be eligible for this asthma and CRS clinical trial?

Adults aged 18 to 99 with a clinical diagnosis of asthma receiving moderate to severe asthma treatment may be eligible. Participants may have nasal polyps or CRS without asthma in some groups. Both men and women can join. Certain health conditions and recent treatments may disqualify you. Please review eligibility criteria for more details.

Is there any cost to participate in this asthma and CRS clinical trial?

Study-related care, including tests and procedures, is provided at no cost. However, personal travel and related expenses may vary and are not always covered. Participants should plan for any additional costs associated with attending visits.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 99Years

All Genders

ID05009758

Exploring Inflammatory Patterns in Asthma and Chronic Rhinosinusitis with Nasal Polyps to Advance Precision Medicine in United Airways Disease

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

Participants Needed

Research Sites

65 weeks

Total Duration

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

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

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

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)