Treatment with Mepolizumab for severe eosinophilic asthma and nasal polyps
Biomarkers Evaluation and Effect of Mepolizumab on Lower and Upper Airways Inflammation in Severe Refractory Eosinophilic Asthma and Nasal Polyposis
Istituti Clinici Scientifici Maugeri SpA · NCT05063981
This study is testing if the medication Mepolizumab can help people with severe asthma and nasal polyps feel better by reducing inflammation in their bodies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA (other) |
| Drugs / interventions | Mepolizumab |
| Locations | 1 site (Telese Terme, BN) |
| Trial ID | NCT05063981 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with severe refractory eosinophilic asthma, with or without chronic rhinosinusitis with nasal polyposis (CRSwNP). It aims to evaluate the effects of Mepolizumab on nasal, bronchial, and systemic inflammation in these patients. The study will assess how this treatment can improve disease control and manage the associated comorbidities. Participants must meet specific criteria related to their asthma severity and eosinophil levels.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with severe refractory asthma and elevated eosinophil counts.
Not a fit: Patients with conditions such as Eosinophilic Granulomatosis with Polyangiitis or serious cardiopulmonary disorders may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could significantly improve asthma control and quality of life for patients suffering from severe eosinophilic asthma and nasal polyps.
How similar studies have performed: Other studies have shown promising results with Mepolizumab in treating severe asthma, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:age \>18 years * diagnosis of severe refractory asthma according to the ERS/ATS criteria ATS * Blood eosinophils \>150 cells/mcL at the screening visit and at least one value of 300 or more eosinophils/mcL during the previous year; * at least two exacerbations despite maximal therapy with long-acting bronchodilators and high dose inhaled corticosteroids in the previous year or the need for continued therapy with oral corticosteroids in addition to maximal inhaled therapy for at least 6 months in the previous year * written informed consent. * For CRSwNP diagnosis, the EPOS 2020 guidelines will be considered as reference. All the above-mentioned inclusion criteria must be met. Exclusion Criteria:Pregnancy * Eosinophilic Granulomatosis with Polyangiitis (EGPA); * Serious life threatening cardiopulmonary disorders; * Systemic immunologic disorder in the last 12 months; * Positive history for malignant tumors ever in patient's life; * Immunodeficiency.
Where this trial is running
Telese Terme, BN
- Istituti Clinici Scientifici Maugeri IRCCS — Telese Terme, BN, Italy (RECRUITING)
Study contacts
- Study coordinator: Mauro Maniscalco, MD
- Email: mauro.maniscalco@icsmaugeri.it
- Phone: +390824909350
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.
Conditions: Asthma, Nasal Polyps, Sinusitis Chronic