DETACT sEvere asThmAtiC paTients - a Pilot Study

Korábbi kezelés

• experience of an asthma exacerbation within 4 weeks prior to the first main visit
• immune disorder and/or immunosuppressive treatment (e.g. cyclosporine), ongoing biological treatment of asthma (e.g., mepolizumab, omalizumab, benralizumab) or last biological treatment 2 half-lives or 1 month before the first main visit

Más betegség

• suffer from additional others confounding underlying lung disorder including but not limited to: Bronchiectasis, chronic obstructive pulmonary disorder (COPD), pulmonary fibrosis, emphysema, Cystic fibrosis, any known parasitic infections and lung cancer.
• show pulmonary conditions with symptoms of asthma and blood eosinophilia, including but not limited to: Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, hypereosinophilic syndrome
• suffer from a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study,
• have a history of drug and alcohol abuses

Egyéb

• Patients who:
• are pregnant as determined by a ß-HCG test
• have severe anatomic variations or deviations that do not allow bronchoscopy
• have clinically meaningful comorbidity as determined by the evaluating committee,
• are currently smoking or are former smokers for less than 6 months with >10 pack years

• All patients who:
• are ≥18 years of age
• have a recorded clinical diagnosis of asthma (ICD-10 Code: J45)
• meet the requirements for treatment of severe T2-high asthma for Dupilumab defined as:
• FeNO > 25 ppB
• two measurements of at least 250 eosinophils /µl in the blood OR one measurement of blood eosinophils at least 250 cells/µl during reduction of OCS dosing if treated with oral corticosteroids and/or one measurement of sputum ≥ 2% or BAL eosinophils ≥ 1%
• have a history of treatment with monoclonal antibodies for asthma if a wash out period of 2 half-lives or 1 month (whatever is longer) has passed