Phase
Condition
Sinusitis
Polyps
Sinus Infections
Treatment
FeNO
Medical history of patients, demographic data, concomitant medication, questionnaire
Blood sampling
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 orstep 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 measurementof blood eosinophils >= 250 cells/µl (one of the two measurements at the screeningvisit) 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 tothe 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 EuropeanPosition Paper on Rhinosinusitis and Nasal Polyps Guidelines
Evidence of Type 2 inflammation: eosinophils >= 250 cells/µl measured in the bloodOR 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 polypswill only be included if at least a wash out period of 5 half-lives or at least 3months have passed
Exclusion
Exclusion Criteria:
Pregnancy (as determined by ß-HCG test)
Patients with severe anatomic variations or deviations that do not allow access toall areas in the nasal cavity
Patients undergoing chronic oral corticosteroid therapy
Patients with any other confounding underlying lung disorder including but notlimited to:
Bronchiectasis, chronic obstructive pulmonary disorder (COPD), pulmonaryfibrosis, emphysema, primary ciliary dyskinesia
Cystic fibrosis, any known parasitic infections, and lung cancer
Patients with pulmonary conditions with symptoms of asthma and blood eosinophiliaincluding 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, andpossible consequences of the study
Patients with clinically meaningful comorbidity as determined by the evaluatingcommittee
Patients with a history of exacerbation of chronic rhinosinusitis or asthma 4 weeksprior 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
Study Design
Study Description
Connect with a study center
Allgemeines Krankenhaus (AKH) Wien
Wien, 1090
AustriaActive - Recruiting
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