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

NCT05787678 | Unknown

• 1 other identifier: IIBSP-DUP-2022-58
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Asthma; Eosinophilic

Outcome Measures

Primary Outcomes (1)

• Number of bronchial inflammatory cells

  Count of induced sputum leucocytes

  1 year

Secondary Outcomes (1)

• Mucin production from epithelial cells

  1 year

Interventions

Dupilumab BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Severe uncontrolled eosinophilic asthma by GINA criteria with clinical indication of dupilumab

You may qualify if:

• years
• Severe uncontrolled eosinophilic asthma by GINA (Global Initiative for Asthma) criteria
• Clinical indication of Dupilumab

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90.

Barcelona, Barcelona, 08041, Spain

RECRUITING

Related Publications (15)

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  PMID: 29782224 BACKGROUND

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Induced sputum samples

MeSH Terms

Conditions

Pulmonary Eosinophilia

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypereosinophilic Syndrome; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 28, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 4, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)