Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 12:03 AM
NCT ID:
NCT05009758
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05009758
Study Brief:
Protocol Section:
NCT05009758