Evaluating Dupilumab's effects on asthma inflammation and mucus production
Dupilumab Efficacy on Bronchial Inflammation, Small Airways Disfunction and Mucous Secretion in the Real Life Severe Asthma Patients
This study is testing if Dupilumab can help people with severe asthma by reducing inflammation and mucus production in their lungs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Academic / other |
| Drugs / interventions | Dupilumab |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT05787678 on ClinicalTrials.gov |
What this trial studies
This unicentric observational study aims to assess the efficacy of Dupilumab in reducing bronchial inflammation, small airway dysfunction, and mucous secretion in patients with uncontrolled severe eosinophilic asthma. Participants will undergo a series of evaluations, including demographic data collection, blood analyses, spirometry, and induced sputum analysis at three different time points: before treatment, after 4-5 months, and after 12 months of Dupilumab therapy. The study will also utilize advanced techniques such as 3D culture of nasal epithelial cells and quantitative proteomic analysis to identify potential biomarkers related to asthma.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-80 with severe uncontrolled eosinophilic asthma as defined by GINA criteria.
Not a fit: Patients who have a smoking history of over 10 pack-years or have received monoclonal antibody treatments in the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Dupilumab in managing severe asthma symptoms and improving patient quality of life.
How similar studies have performed: Other studies have shown promising results with Dupilumab in treating asthma, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Barcelona
- Hospital de la Santa Creu i Sant Pau. Carrer Mas Casanovas 90. — Barcelona, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.