NCT07025200Recruiting
DETACT sEvere asThmAtiC paTients - a Pilot Study
Effect of Dupilumab on Mucus Plugs and Inflammatory Patterns in Severe Asthmatic Patients - a Pilot Study
Source: ClinicalTrials.gov · Last updated 17 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10 (estimated)
- First submitted
- 2 Feb 2024
- Start date
- 16 Feb 2023
- Primary completion date
- Jun 2026
- Lead sponsor
- Medical University of Vienna
- Diseases
- Asthma
- NCT number
- NCT07025200
What you commit to
- Study type: Observational
- Planned participants: 10
- From 16 Feb 2023 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna, Clinic of Internal Medicine II, Department of Pulmonology Coordinator of this site? Confirm its status | Vienna | Austria | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.