DETACT — Dupilumab in severe eosinophilic asthma
Effect of Dupilumab on Mucus Plugs and Inflammatory Patterns in Severe Asthmatic Patients - a Pilot Study
This project will try dupilumab in adults with severe Type 2 (eosinophilic) asthma to see if it reduces mucus plugging and changes airway cells, microbes, and metabolites.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna Academic / other |
| Drugs / interventions | Dupilumab, mepolizumab, omalizumab, benralizumab |
| Locations | 1 site (Vienna, State of Vienna) |
| Trial ID | NCT07025200 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with severe Type 2/high-eosinophilic asthma who meet objective criteria (e.g., FeNO >25 ppb and blood eosinophils ≥250 cells/µL or sputum/BAL eosinophilia), are candidates for dupilumab, and can undergo bronchoscopy are ideal candidates.
Not a fit: Patients with non–Type 2 asthma, coexisting lung diseases that confound results (for example bronchiectasis, COPD, pulmonary fibrosis or emphysema), pregnant patients, or those unable to undergo bronchoscopy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the project could show that dupilumab reduces mucus plugging and clarifies airway-level changes that lead to better breathing and quality of life for some patients with severe eosinophilic asthma.
How similar studies have performed: Dupilumab has previously reduced exacerbations and improved control in Type 2 asthma, but direct effects on mucus plugging and detailed airway cellular/microbial/metabolomic changes remain largely unexplored and are the novel focus of this pilot.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Vienna, State of Vienna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.