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Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion

Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion in the Real Life Severe Asthma Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05787678
Acronym
DEBORA
Enrollment
30
Registered
2023-03-28
Start date
2023-10-01
Completion date
2024-12-31
Last updated
2024-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma; Eosinophilic

Brief summary

Unicentric prospective real life study designed to analyse the efficacy of Dupilumab to reduce bronchial inflammation of asthma measured by inflammatory cell counts obtained in induced sputum and other related characteristics (small airway dysfunction and mucin production) in uncontrolled severe asthma patients in the real life setting without control group

Detailed description

After patients signed informed consent, before (visit 1), after 4-5 months (visit 2), and after 12 months (visit 3) Dupilumab treatment began, the following techniques and measurements will be performed or collected: demographic data, blood analyses (eosinophil counts and total IgE), skin prick-test to common aeroallergens (only in the visit 1), asthma control test (ACT), sino-nasal outcome test (SNOT-22), test of adherence to inhalers (TAI), number of severe asthma exacerbations (in the previous year; in the visit 2, in the previous 4 months), oral and inhaled steroid daily doses received, spirometry, exhaled nitric oxide (FeNO), pulmonary volumes, carbon monoxide transference, oscillometry, and induced sputum (inflammatory cell counts and mucin profile \[MUC1, MUC2, MUC5AC, MUC5B\]). All patients will be performed at visits 1 and 3 in a 3D culture of primary nasal epithelial cells from asthmatic patients the pattern of gene and to identify new soluble biomarkers through quantitative proteomic analysis of culture supernatants. Also a chest CT scan with expiratory images will be done only in visits 1 and 3.

Interventions

BIOLOGICALDupilumab

600 mg (two 300 mg injections), followed by 300 mg monthly

Sponsors

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 18 -80 years * Severe uncontrolled eosinophilic asthma by GINA (Global Initiative for Asthma) criteria * Clinical indication of Dupilumab

Exclusion criteria

* Smoking over 10 pack/year * Treatment with monoclonal antibodies treatment during the previous three months * Refuse to sign informed consent

Design outcomes

Primary

MeasureTime frameDescription
Number of bronchial inflammatory cells1 yearCount of induced sputum leucocytes

Secondary

MeasureTime frameDescription
Mucin production from epithelial cells1 yearLevels of MUC 1, MUC2, MUC5AC, and MUC5B

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026