DETACT sEvere asThmAtiC paTients - a Pilot Study

NCT07025200 | Recruiting FDA Drug

• 1 other identifier: 1741/2022
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 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

Asthma

Outcome Measures

Primary Outcomes (1)

• 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.

  26 weeks

Secondary Outcomes (10)

• Change in asthma control

  26 weeks

• Change in number of asthma exacerbations

  26 weeks

• Change in peripheral blood eosinophil count (PBEC)

  26 weeks

• Change in forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)

  26 weeks

• Change in fractional exhaled nitric oxide (FeNO)

  26 weeks

Other Outcomes (1)

• Safety and Tolerability

  26 weeks

Study Arms (1)

Dupilumab treated patients

All patients will be administered subcutaneous doses of dupilumab every 2 weeks.

Drug: Dupilumab

Interventions

Dupilumab DRUG

Clinical assessment, lung function, CT-scans and Bronchoscopy prior to and 22 weeks after initiation of Dupilumab.

Dupilumab treated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe Type 2 asthma for whom Dupilumab therapy is indicated.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Clinic of Internal Medicine II, Department of Pulmonology

Vienna, Vienna, 1090, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

For the purpose of the study we will collect blood samples as well as bronchoscopy-derived samples as bronchoalveolar lavage (BAL) fluid, bronchial lining fluid and bronchial biopsies

MeSH Terms

Conditions

Asthma

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Marco Idzko, M.D.

CONTACT

+43140400; marco.idzko@meduniwien.ac.at

Slagjana Stoshikj, M.D.

CONTACT

+43140400; slagjana.stoshikj@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr.

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: June 17, 2025
• Study Start: February 16, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

AU (1)