NCT05787678

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: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma; Eosinophilic

Interventions

Type	Name	Description
BIOLOGICAL	Dupilumab	600 mg (two 300 mg injections), followed by 300 mg monthly

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2023-03-28
• Last updated: 2024-10-04

Locations

1 site across 1 country: Spain