Last updated: January 11, 2022
Sponsor: Policlinico Universitario, Catania
Overall Status: Active - Recruiting
Phase
N/A
Condition
Asthma
Lung Disease
Allergies & Asthma
Treatment
N/AClinical Study ID
NCT05189613
PoliclinicoUC
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 performedprior 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
Exclusion Criteria:
- Poor adherence to severe asthma therapy
- Patients with other respiratory disease that may share common clinical manifestationsof severe asthma (i.e. acute bronchopulmonary aspergillosis, vasculitis and COPD)
- Any medical condition or disease that was not stable during the 3 months prior tomepolizumab treatment (excluding asthma exacerbations), that the investigator believesmay compromise the safety of the patient if enrolled in the study such us atrialfibrillation, acute respiratory failure, acute heart failure, myocardial infarctionand 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 orblood transfusions within 6 weeks prior to mepolizumab treatment;
- Use of drugs that can influence the response to treatment such us immunosuppressantand/or biological therapies
Study Design
Total Participants: 100
Study Start date:
September 01, 2021
Estimated Completion Date:
December 31, 2022
Study Description
Connect with a study center
AOU Policlinico "G. Rodolico-Sto arrivando!n Marco"
Catania, 95125
ItalyActive - Recruiting
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