Effects of Mepolizumab on Severe Eosinophilic Asthma
Effect of Mepolizumab on the Phenotype/Proteome/Transcriptome of Eosinophils in Severe Eosinophilic Asthma
This study is testing how well mepolizumab works for people with severe eosinophilic asthma by comparing them to healthy adults and tracking their progress over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital Clinico Universitario de Santiago Academic / other |
| Drugs / interventions | omalizumab, mepolizumab, prednisone |
| Locations | 5 sites (Ferrol, A Coruña and 4 other locations) |
| Trial ID | NCT04641741 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effects of mepolizumab on patients with severe eosinophilic asthma through a two-part approach. The first part involves a case-control study comparing healthy adults with severe eosinophilic asthmatics selected for mepolizumab treatment. The second part is a longitudinal cohort study that follows these patients over time to assess their response to the treatment at various intervals. The study aims to discover predictive and prognostic biomarkers of response to mepolizumab using advanced techniques such as flow cytometry, transcriptomic, and proteomic analyses.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with a diagnosis of severe eosinophilic asthma and persistent eosinophilia.
Not a fit: Patients with a significant smoking history, other pulmonary diseases, or conditions associated with elevated eosinophil counts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved personalized treatment strategies for patients with severe eosinophilic asthma.
How similar studies have performed: Other studies have shown promise in using biologics like mepolizumab for eosinophilic asthma, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of severe uncontrolled asthma according to ERS/ATS criteria * Persistent eosinophilia in blood (\>300 cells/μL) * Frequent exacerbations (≥ two per year) * Signature of informed consent and agree to comply with all the visits of the study and all the procedures that this entails. Exclusion Criteria: * Smoking history: Current smokers or former smokers with a smoking history of ≥10 pack-years * Clinically important pulmonary disease other than asthma (e.g. active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliary dyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts * • Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator. * Malignancy: A current malignancy or previous history of cancer in remission. * Acute upper or lower respiratory infections requiring antibiotics or antiviral medication within 30 days prior to the Visit 1. * Xolair: Participants who have received omalizumab (Xolair) or another monoclonal antibody previously. * Participants who have received systemic corticosteroids within 30 days before Visit 1 \[53\]. * Pregnancy: Participants who are pregnant or breastfeeding. * Obesity class 2 or higher (BMI≥ 35 kg/m2)
Where this trial is running
Ferrol, A Coruña and 4 other locations
- Complejo Hospitalario Universitario de Ferrol — Ferrol, A Coruña, Spain (Recruiting)
- Hospital Clínico Universitario de Santiago de Compostela — Santiago De Compostela, A Coruña, Spain (Not_yet_recruiting)
- Hospital Povisa - Grupo Ribera Salud — Vigo, Pontevedra, Spain (Not_yet_recruiting)
- Complexo Hospitalario Universitario A Coruña — A Coruña, Spain (Not_yet_recruiting)
- Complexo Hospitalario Universitario de Ourense — Ourense, Spain (Recruiting)
Study contacts
- Principal investigator: Francisco-Javier Gonzalez-Barcala, Md, Phd — Clinic University Hospital
- Study coordinator: Francisco-Javier Gonzalez-Barcala, Md, Phd
- Email: francisco.javier.gonzalez.barcala@sergas.es
- Phone: +34981951173
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.