Clinical trial NCT05787678: Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion
Official title: Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion in the Real Life Severe Asthma Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma; Eosinophilic
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Severe uncontrolled eosinophilic asthma by GINA criteria with clinical indication of dupilumab

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of bronchial inflammatory cells
timeFrame: 1 year
Secondary outcomes:
measure: Mucin production from epithelial cells
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.
Study officials:
References:
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