DETACT — Dupilumab in severe eosinophilic asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective exploratory pilot enrolling about 10 adults with severe T2-high asthma who are candidates for dupilumab. Before treatment the team will collect patient-reported outcomes, spirometry, FeNO, blood tests, ultra high-resolution chest CT, and perform bronchoscopy with bronchoalveolar lavage and biopsies to profile cellular, molecular, microbiological and metabolomic features. Participants will start dupilumab and return every two weeks for clinical checks, drug administration, and safety monitoring, with repeat CT and bronchoscopy after approximately 22 weeks and a maximum individual follow-up of 26 weeks. The study includes patients meeting objective T2/eosinophilic thresholds and allows prior biologic-treated patients after an appropriate washout period.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of Vienna, Clinic of Internal Medicine II, Department of Pulmonology
  Vienna, State of Vienna, Austria Recruiting

Study contacts

• Study coordinator: Marco Idzko, M.D.
• Email: marco.idzko@meduniwien.ac.at
• Phone: +43140400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.