SEVERE ASTHMA MedDRA version: 21.1 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
Conditions
Interventions
Product Name: FASENRA
Product Code: [MEDI-563]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Benralizumab
CAS Number: 1044511-01-4
Current Sponsor code: MEDI-563
Other descriptive n
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO “PAOLO GIACCONE” DI PALERMO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female with age over 18 yrs. 2. Clinical diagnosis of persistent asthma for at least 6 months, according to GINA guidelines; 3. Existing treatment with high dose inhaled corticosteroids (ICS>500 mcg total daily dose of fluticasone propionate) in combination with other 2 controllers (LABA, LAMA, LTRA) for at least 3 months. 4. Positive methacholine challenge test (PC20 FEV1=65 years) yes F.1.3.1 Number of subjects for this age range 11
Exclusion criteria
Exclusion criteria: 1. Inability to carry out pulmonary function testing; 2. Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary disease (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g. active peptic ulcer), cardiovascular diseases (cardiac arrhythmia, unstable angina, congestive heart failure, aneurysm), neurological or haematological autoimmune diseases; 3. Malignancy; 4. Any chronic diseases with prognosis 10 pack-years; 8. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 9. Patients who are participating to other clinical studies. 10. Impaired DLCO suggestive of diseases other than asthma (i.e. Emphysema). 11. A helminth parasitic infection within 24 weeks that has not been treated with, or has failed to respond to, standard of care therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. to assess wthether the effect of Benralizumab on HRCT markers of remodeling parallels the improvement in the disease, assessed by a reduction in the frequency and severity of respiratory symptoms as well as rate and seveity of exacerbations. 2. to assess wthether the effect of Benralizumab on biomarkers of airways inflammation (exhaled bronchial and alveolar nitric oxide (NO) concentrations and blood and sputum eosinophils levels) parallels the improvement in the control of the disease, assessed by a reduction in the frequency and severity of respiratory symptoms as well as rate and seveity of exacerbations.;Main Objective: TO EVALUATE THE EFFICACY OF BENRALIZUMAB TO REDUCE AIRWAY INFLAMMATION AND FEATURE OF AIRWAY REMODELING EVALUATED BY HRCT;Primary end point(s): To reduce number of exacerbations and symptoms of severe asthma;Timepoint(s) of evaluation of this end point: 52 weeks | — |
Countries
Italy
Contacts
Public ContactPI
Nicola Scichilone A.O. Universitaria Policlinico Paolo Giaccone
Outcome results
None listed