AsthmaDETACTNCT07025200
DETACT sEvere asThmAtiC paTients - a Pilot Study
An observational study of Asthma, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Dupilumab
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteAustria
- Study dates
- 16 Feb 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe Type 2 asthma for whom Dupilumab therapy is indicated.
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna, Clinic of Internal Medicine II, Department of Pulmonology
Vienna, State of Vienna, 1090
Marco Idzko, M.D., +43140400 ext. 47740, marco.idzko@meduniwien.ac.at
Slagjana Stoshikj, M.D., +43140400 ext. 47740, slagjana.stoshikj@meduniwien.ac.at
About this study
Official title: Effect of Dupilumab on Mucus Plugs and Inflammatory Patterns in Severe Asthmatic Patients - a Pilot Study
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.
Read the detailed description
In this prospective exploratory pilot study, the objective is to enroll 10 participants with severe asthma who are candidates for Dupilumab treatment. The study's individual duration will not exceed 26 weeks. Before enrollment, informed consent will be obtained from all subjects. All patients with severe Type 2 Asthma can be included according to inclusion- and exclusion criteria. Those with a history of monoclonal antibody treatment for asthma may be included after a washout period of 2 half-lives or 1 month (whichever is longer).
Prior to commencing Dupilumab, the investigators will assess patient-reported outcomes using the Asthma Control Questionnaire (ACQ-6), Asthma Control Test (ACT), and mini Asthma Quality of Life Questionnaire (miniAQLQ). Additionally, the investigators will review concomitant medication, conduct Spirometry, measure fraction of exhaled nitric oxide (FeNO), perform ultra high-resolution computer tomography of the lungs, draw blood for laboratory samples, and carry out bronchoscopy with bronchoalveolar lavage and biopsies.
Subsequently, Dupilumab treatment will be initiated, and patients will visit our center every 2 weeks for clinical assessments, including monitoring adverse events, lung function, laboratory samples, and Dupilumab administration. After 22 weeks, the investigators will repeat computer tomography of the lungs and bronchoscopy. For patients who do not experience clinical improvement, Dupilumab treatment will be discontinued after 6 months.
- Conditions
- Asthma
- Being tested
- Dupilumab
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Clinical assessment, lung function, CT-scans and Bronchoscopy prior to and 22 weeks after initiation of Dupilumab.
| Study group | Role | What they receive |
|---|---|---|
| Dupilumab treated patients | All patients will be administered subcutaneous doses of dupilumab every 2 weeks. Receives: Drug: Dupilumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Dupilumab treatment on mucus plugging in patients with severe eosinophilic asthma
CT scans of the lungs will be done on baseline and 22 weeks after begin applying ultra-high resolution CT technique (special resolution 0.2 mm). The examinations will be performed as no-contrast CTs in sustained deep inspiration and expiration. The images will be investigated and scored independently by two thoracic radiologists. Both radiologists will score the extent of air-trapping, bronchial wall thickening and mucus plugging per pulmonary segment based on the following scale:
- absent (0)
- minimal (1)
- moderate (2)
- extensive (3) Prior to the evaluation of study scans, both radiologists will undergo a consensus reading on CT scans not included in the study.
Measured: 26 weeks
Secondary outcomes (10)
Change in asthma control
We will assess change in asthma control under Dupilumab treatment using the Asthma Control Test (ACT), Asthma Control Questionnaire-6 (ACQ-6) and mini Asthma Quality of Life Questionnaire (mAQLQ).
Measured: 26 weeks
Change in number of asthma exacerbations
Asthma exacerbations will be defined as events requiring the use of systemic corticosteroids for at least three consecutive days.
Measured: 26 weeks
Change in peripheral blood eosinophil count (PBEC)
PBEC, measured in cells per microliter (cells/µL), will be assessed every two weeks at the clinic.
Measured: 26 weeks
Change in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
FEV₁ and FVC, expressed in milliliters (mL) and as percentages of the predicted values, will be assessed during clinic visits. Additionally, patients will receive home spirometry devices to enable more frequent lung function monitoring between appointments
Measured: 26 weeks
Change in fractional exhaled nitric oxide (FeNO)
FeNO will be measured daily at home using portable devices, as well as every two weeks at the clinic. Measurements will be expressed in parts per billion (ppb).
Measured: 26 weeks
Change in Cellular Composition and Activation
Characterization of immune cell populations and their activation states isolated from bronchoalveolar lavage (BAL) cells.
Measured: 26 weeks
Change in Inflammatory Mediators
Quantification of inflammatory mediator concentrations in BAL supernata
Measured: 26 weeks
Change in Transcriptional Profiling
Analysis of gene expression profiles in BAL cells and lung tissue using transcriptional sequencing techniques.
Measured: 26 weeks
Lung Microbiome
Assessment of microbial community composition in BAL samples.
Measured: 26 weeks
Metabolomic Profile
Characterization of metabolite composition in BAL fluid.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start16 Feb 2023
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Idzko, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025200
- Sponsor's protocol ID
- 1741/2022
- Acronym
- DETACT
- Status last verified
- Jun 2025
- First submitted
- 2 Feb 2024
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dupilumab on Mucus Plugs and Inflammatory Patterns in Severe Asthmatic Patients - a Pilot Study
- ClinicalTrials.gov ID
- NCT07025200
- Acronym / sponsor ID
- DETACT / 1741/2022
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
In this prospective exploratory pilot study, the objective is to enroll 10 participants with severe asthma who are candidates for Dupilumab treatment. The study's individual duration will not exceed 26 weeks. Before enrollment, informed consent will be obtained from all subjects. All patients with severe Type 2 Asthma can be included according to inclusion- and exclusion criteria. Those with a history of monoclonal antibody treatment for asthma may be included after a washout period of 2 half-lives or 1 month (whichever is longer).
Prior to commencing Dupilumab, the investigators will assess patient-reported outcomes using the Asthma Control Questionnaire (ACQ-6), Asthma Control Test (ACT), and mini Asthma Quality of Life Questionnaire (miniAQLQ). Additionally, the investigators will review concomitant medication, conduct Spirometry, measure fraction of exhaled nitric oxide (FeNO), perform ultra high-resolution computer tomography of the lungs, draw blood for laboratory samples, and carry out bronchoscopy with bronchoalveolar lavage and biopsies.
Subsequently, Dupilumab treatment will be initiated, and patients will visit our center every 2 weeks for clinical assessments, including monitoring adverse events, lung function, laboratory samples, and Dupilumab administration. After 22 weeks, the investigators will repeat computer tomography of the lungs and bronchoscopy. For patients who do not experience clinical improvement, Dupilumab treatment will be discontinued after 6 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dupilumab treated patients | – | Drug: DupilumabAll patients will be administered subcutaneous doses of dupilumab every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe Type 2 asthma for whom Dupilumab therapy is indicated.
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabClinical assessment, lung function, CT-scans and Bronchoscopy prior to and 22 weeks after initiation of Dupilumab. | Drug | Dupilumab treated patients |
Primary outcome
Effect of Dupilumab treatment on mucus plugging in patients with severe eosinophilic asthma
Time frame: 26 weeks
CT scans of the lungs will be done on baseline and 22 weeks after begin applying ultra-high resolution CT technique (special resolution 0.2 mm). The examinations will be performed as no-contrast CTs in sustained deep inspiration and expiration. The images will be investigated and scored independently by two thoracic radiologists. Both radiologists will score the extent of air-trapping, bronchial wall thickening and mucus plugging per pulmonary segment based on the following scale: * absent (0) * minimal (1) * moderate (2) * extensive (3) Prior to the evaluation of study scans, both radiologists will undergo a consensus reading on CT scans not included in the study.
10 secondary outcomes
Change in asthma control
Time frame: 26 weeks
Change in number of asthma exacerbations
Time frame: 26 weeks
Change in peripheral blood eosinophil count (PBEC)
Time frame: 26 weeks
Change in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
Time frame: 26 weeks
Change in fractional exhaled nitric oxide (FeNO)
Time frame: 26 weeks
Change in Cellular Composition and Activation
Time frame: 26 weeks
Change in Inflammatory Mediators
Time frame: 26 weeks
Change in Transcriptional Profiling
Time frame: 26 weeks
Lung Microbiome
Time frame: 26 weeks
Metabolomic Profile
Time frame: 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco Idzko, M.D. (+43140400 ext. 47740, marco.idzko@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Dupilumab treatment on mucus plugging in patients with severe eosinophilic asthma (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.