Moving Towards Precision Medicine in United Airways Disease: Unraveling Inflammatory Patterns in Asthmatic Patients With or Without Nasal Polyps (PREMIUM)
Asthma, Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis (Diagnosis)
About this trial
This is an interventional screening trial for Asthma focused on measuring Asthma, Chronic Rhinosinusitis (CRS), CRS with Nasal Polyps, CRS without Nasal Polyps, Inflammatory profile, Type 2 inflammation
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
Sites / Locations
- Allgemeines Krankenhaus (AKH) WienRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
T2-high asthma with nasal polyps
T2-high asthma without nasal polyps
CRSwNP in absence of asthma
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 Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and CRSwNP Guidelines) Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a washout period of 5 half-lives or at least 3 months have passed
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 Absence of NP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and CRSwNP Guidelines) Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a washout period of 5 half-lives or at least 3 months have passed
Presence of CRSwNP as confirmed by endoscopy or CT according to the European Position Paper on Rhinosinusitis and Nasal Polyps Guidelines26 Evidence of Type 2 inflammation: blood eosinophils >= 250 cells/µl measured in the blood OR total IgE >100 kU/L26 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 washout period of 5 half-lives or at least 3 months have passed