Effect of Dupilumab on Mucus Plugs and Inflammatory Patterns in Severe Asthmatic Patients - a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Austria
Medical University of Vienna, Clinic of Internal Medicine II, Department of Pulmonology
RECRUITING
Vienna
Contact Information
Primary
Marco Idzko, M.D.
marco.idzko@meduniwien.ac.at
+43140400
Backup
Slagjana Stoshikj, M.D.
slagjana.stoshikj@meduniwien.ac.at
+43140400
Time Frame
Start Date: 2023-02-16
Estimated Completion Date: 2026-12
Participants
Target number of participants: 10
Treatments
Dupilumab treated patients
All patients will be administered subcutaneous doses of dupilumab every 2 weeks.
Related Therapeutic Areas
Sponsors
Leads: Medical University of Vienna

This content was sourced from clinicaltrials.gov