Investigating Inflammatory Patterns in Asthma and Nasal Polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the relationship between asthma and chronic rhinosinusitis (CRS) by examining patients with asthma and CRS with or without nasal polyps. It aims to characterize these conditions through clinical assessments, including lung function tests and blood analysis for eosinophils. Additionally, the study will involve in-depth sampling from the nose, oropharynx, and lungs to understand the inflammatory profiles associated with these diseases. The goal is to uncover the cellular and molecular connections between the upper and lower respiratory tracts, which are thought to function as a single organ.

Why it matters

Who can join: the full rules

Inclusion Criteria:

All patients who

* 18-99 years of age
* have a recorded clinical diagnosis of asthma (ICD-10 Code: J45)
* undergo moderate-serve asthma treatment according to GINA/DAL treatment step 4 or step 5 without oral corticosteroid or monoclonal antibody therapy
* Asthma treatment for a minimum of 12 weeks prior to screening visit

  * Group 1 and 2 - T2-high asthma with or without polyps:
* FeNO \> 25 ppB
* had either two times \>= 250 eosinophils /µl measured in the blood OR one measurement of blood eosinophils \>= 250 cells/µl (one of the two measurements at the screening visit) and/or one measurement of sputum eosinophils \> 2% within the last 12 months
* Group with polyps: Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and CRSwNP Guidelines)

  * Group 3 - CRSwNP in absence of asthma:
* Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines
* Evidence of Type 2 inflammation: eosinophils \>= 250 cells/µl measured in the blood OR total IgE \>100 kU/L at the screening visit
* Absence of asthma and N-ERD
* Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a wash out period of 5 half-lives or at least 3 months have passed

Exclusion Criteria:

* Pregnancy (as determined by ß-HCG test)
* Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity
* Patients undergoing chronic oral corticosteroid therapy
* Patients with any other confounding underlying lung disorder including but not limited to:

  * Bronchiectasis, chronic obstructive pulmonary disorder (COPD), pulmonary fibrosis, emphysema, primary ciliary dyskinesia
  * Cystic fibrosis, any known parasitic infections, and lung cancer
* Patients with pulmonary conditions with symptoms of asthma and blood eosinophilia including but not limited to: Eosinophilic granulomatosis with polyangiitis (EGPA), allergic bronchopulmonary aspergillus, and hypereosinophilic syndrome
* A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
* Patients with clinically meaningful comorbidity as determined by the evaluating committee
* Patients with a history of exacerbation of chronic rhinosinusitis or asthma 4 weeks prior to any visit
* Intake of a burst of systemic corticosteroids 4 weeks prior to any visit.
* Immunosuppressive treatment (e.g. cyclosporine)
* Drug and alcohol abuses
* Current smoker
* Former smoker if stopped smoking \<6 months and/or has \>10 pack-years

Where it's running

• Allgemeines Krankenhaus (AKH) Wien
  Vienna, Austria Recruiting

Study contacts

• Principal investigator: Julia Eckl-Dorna, PhD — Medical University of Vienna
• Study coordinator: Julia Eckl-Dorna, PhD
• Email: julia.eckl-dorna@meduniwien.ac.at
• Phone: +4314040034380

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.