The Role of Benralizumab on airway Remodeling Assessed by HRCT in severe asthma (BREATH Study) - BREATH Study

AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO PAOLO GIACCONE” DI PALERMO0 个研究点目标入组 20 人开始时间: 2021年5月24日最近更新: 2021年9月7日

适应症

试验速览

暂无简介。

•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< 4mg/ml or PD20 FEV1<0.8 mg) or positive response to the spirometry with reversibility test in the previous year; reversibility test is positive if the pre-salbutamol FEV1 increases more than 200 mL and 12%, 15 min after the administration of 400 mg of salbutamol.
•5. A forced expiratory volume in 1 second (FEV1<80% of predicted normal during the screening period);
•6. History of 2 or more exacerbations in the previous year requiring systemic corticosteroids;
•7. Blood eosinophil count of at least 300 cells per mcL.
•8. Motivation to complete all the study visits and procedure, and ability to communicate well with the investigator and be capable of understanding the nature of the research.
•9. Ability to comprehend and complete questionnaires on respiratory symptoms.
•10. Written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 11

•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 < 2 years;
•5. Pregnant or lactating females or not able to exclude pregnancy during the study period;
•6. History of alcohol or drug abuse;
•7. Current smoker with a smoking history >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

发起方

AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO PAOLO GIACCONE” DI PALERMO