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

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

Status

Enrolling

Conditions

Asthma; Eosinophilic

Treatments

Biological: Dupilumab

Study type

Observational

Funder types

Other

Identifiers

NCT05787678

IIBSP-DUP-2022-58

Details and patient eligibility

About

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

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria