Actively Recruiting
DETACT sEvere asThmAtiC paTients - a Pilot Study
Led by Medical University of Vienna · Updated on 2025-06-17
10
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DETACT sEvere asThmAtiC paTients - a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older
- Have a recorded clinical diagnosis of asthma (ICD-10 Code: J45)
- Meet criteria for severe Type 2-high asthma treatment with Dupilumab, including FeNO > 25 ppB
- Have at least two blood eosinophil counts of 250 cells/µl or higher, or one elevated blood eosinophil count during oral corticosteroid reduction, or sputum eosinophils ≥ 2% or BAL eosinophils ≥ 1%
- Have completed a washout period of 2 half-lives or 1 month if previously treated with monoclonal antibodies for asthma
You will not qualify if you...
- Are pregnant as confirmed by a ß-HCG test
- Have severe anatomical issues preventing bronchoscopy
- Have other lung disorders such as bronchiectasis, COPD, pulmonary fibrosis, emphysema, cystic fibrosis, parasitic infections, or lung cancer
- Have pulmonary conditions with asthma symptoms and blood eosinophilia like Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, or hypereosinophilic syndrome
- Have mental conditions impairing understanding of the study
- Have clinically significant comorbidities
- Experienced an asthma exacerbation within 4 weeks before the first main visit
- Have immune disorders or are on immunosuppressive or ongoing biological treatments for asthma within specified timeframes
- Have a history of drug or alcohol abuse
- Are current smokers or former smokers with less than 6 months abstinence and more than 10 pack years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Medical University of Vienna, Clinic of Internal Medicine II, Department of Pulmonology
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
Research Team
M
Marco Idzko, M.D.
CONTACT
S
Slagjana Stoshikj, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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