Effect of Dupilumab an mucus plugs and inflammatory patterns in sEvere asThmAtiC paTients — a Pilot Study (DETACT)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

2 Feb 2023 → ongoing

Decision date (initial)

2024-12-10

Transition trial

Yes

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-517567-23-00

EudraCT number

2022-003303-14

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

To evaluate the effect of Dupilumab on mucus plugging in the airways of patients suffering from severe asthma

Secondary objectives 8

1. are to evaluate the effect of Dupilumab treatment on: cellular composition and activation pattern of immune cells isolated from bronchoalveolar lavage (BAL)
2. inflammatory mediator concentrations in BAL supernatant
3. transcriptional expression profile in BAL cells and lung tissue
4. composition of the lung microbiome in BAL
5. characteristics of the metabolom in BAL
6. blood eosinophils
7. FeNO-values over the course of this study
8. Lung function over the course of this study

Conditions and MedDRA coding

severe asthma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. ≥18 years of age
2. a recorded clinical diagnosis of asthma (ICD-10 Code: J45)
3. Meeting the Dupilumab treatment requirements for severe T2-high asthma: o FeNO > 25 ppB o had either twice 250 eosinophils /µl measured in the blood OR one measurement of blood eosinophils 250 cells/µl during reduction of OCS dosing if treated with oral corticosteroids o one measurement of sputum ≥ 2% or BAL eosinophils ≥ 1%
4. Patients with history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a wash out period of 2 half -lives or 1 months has passed

Exclusion criteria 10

1. pregnancy (positive ß-HCG test)
2. severe anatomic variations or deviations that do not allow bronchoscopy
3. confounding lung disorders except asthma including: o chronic obstructive pulmonary disorder (COPD) and emphysema, pulmonary fibrosis o Cystic fibrosis, any known parasitic infections and lung cancer
4. a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
5. clinically meaningful comorbidities
6. experience of an asthma exacerbation within 4 weeks prior to the first main visit
7. 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 befor the first main visit
8. Low dose systemic corticosteroid therapy for asthma is allowed
9. drug and/or alcohol abuse
10. Current smoker or former smoker if stopped smoking <6 months and/or has a smoking history of >10 pack years

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To evaluate the effect of Dupilumab on mucus plugging in the airways of patients suffering from severe asthma

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Medical University of Vienna Department of Medicine II Division of Pulmonology

Public contact point

Organisation

Medical University Of Vienna

Contact name

Medical University of Vienna Department of Medicine II Division of Pulmonology

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications