DETACT sEvere asThmAtiC paTients - a Pilot Study

Summary

The objective of this study is to investigate the effect of dupilumab treatment on mucus plugging in severe asthma patients with severe eosinophilic asthma. Therefore, the investigators plan to apply computer tomography to investigate mucus plugging and thoroughly examine different airway samples from Type 2-high severe asthmatic patients at a cellular, molecular, microbiological and metabolomic level. This study will help to unravel underlying treatment mechanisms of dupilumab therapy in severe asthmatics.

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Patients who:

* are pregnant as determined by a ß-HCG test
* have severe anatomic variations or deviations that do not allow bronchoscopy
* 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 clinically meaningful comorbidity as determined by the evaluating committee,
* 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
* have a history of drug and alcohol abuses
* are currently smoking or are former smokers for less than 6 months with \>10 pack years

Conditions1

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