Status:
UNKNOWN
Mepolizumab Effectiveness in Severe Eosinophilic Asthma and Bronchiectasis
Lead Sponsor:
Policlinico Universitario, Catania
Conditions:
Bronchial Asthma
Bronchiectasis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Asthma is a chronic respiratory disorder characterized by bronchial inflammation and reversible bronchial obstruction. Severe asthma is an extremely heterogeneous disease, often associated with severa...
Detailed Description
Asthma is a chronic respiratory disorder in which bronchial inflammation, airway hyperresponsiveness, and reversible bronchial obstruction are operant, inciting daily symptoms and triggering unpredict...
Eligibility Criteria
Inclusion
- Male and female with age greater than or equal to 18 years;
- Severe eosinophilic asthma diagnosis according to GINA 2019 report
- Evidence of bronchiectasis in at least one lung lobe in the chest CT scan performed prior to mepolizumab treatment;
- Presence of daily expectoration;
- At least 3 bronchiectasis exacerbations in the year prior to mepolizumab treatment, documented through medical documentation, which required treatment with antibiotics;
- Informed consent obtained from the patient.
Exclusion
- Poor adherence to severe asthma therapy
- Patients with other respiratory disease that may share common clinical manifestations of severe asthma (i.e. acute bronchopulmonary aspergillosis, vasculitis and COPD)
- Any medical condition or disease that was not stable during the 3 months prior to mepolizumab treatment (excluding asthma exacerbations), that the investigator believes may compromise the safety of the patient if enrolled in the study such us atrial fibrillation, acute respiratory failure, acute heart failure, myocardial infarction and acute renal failure.
- Bronchiectasis associated with cystic fibrosis;
- Traction bronchiectasis in the context of pulmonary fibrosis;
- History of lung cancer in the previous 5 years;
- History of significant hemoptysis (≥300 mL of blood) or which required embolization or blood transfusions within 6 weeks prior to mepolizumab treatment;
- Use of drugs that can influence the response to treatment such us immunosuppressant and/or biological therapies
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05189613
Start Date
September 1 2021
End Date
December 31 2022
Last Update
January 12 2022
Active Locations (1)
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1
AOU Policlinico "G. Rodolico-Sto arrivando!n Marco"
Catania, Italy, 95125