Bronchiectasis
Conditions
Interventions
Experimental group:biological agents targeting type 2 inflammation(including Dupilumab,Mepolizumab or Benralizumab)
Positive control group:inhaled corticosteroids (ICS)/long-acting bronchodilators combinations
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Outpatient patients aged 18 to 75 years old with chronic cough and expectoration symptoms, clinically diagnosed with bronchiectasis; 2. Chest CT indicates bronchiectasis in at least one lung lobes; 3. Patients are in the stable phase of bronchiectasis (without significant changes in respiratory symptoms in both day and night or acute exacerbation of bronchiectasis or acute upper respiratory tract infection during last 4 consecutive weeks); 4. Having type 2 inflammatory characteristics: Peripheral blood eosinophil count = 150/µ L; 5. Evidence of airflow limitation, with FEV1 being less than 80% of the expected value before using bronchodilators; 6. History of at least one acute exacerbation of bronchiectasis during last 12 months; 7. Expected survival period greater than 12 months; 8. Agree to take contraceptive measures after entering the study; 9. Agree to participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with active pulmonary infection (including active tuberculosis, active NTM infection requiring treatment), pulmonary arterial hypertension, lung cancer (survival patients who have not received any anti-tumor treatment for at least 5 years after surgery could be included), and other major pulmonary or systemic diseases (such as pulmonary fibrosis, pulmonary arterial hypertension, etc.); 2. Bronchiectasis caused by cystic fibrosis (CF) or alpha 1-antitrypsin deficiency; 3. moderate or severe hemoptysis due to bronchiectasis within the past six months (moderate hemoptysis: 24-hour hemoptysis volume of 100-499ml; severe hemoptysis: 24-hour hemoptysis volume of 500ml or more, or a single hemoptysis volume exceeding 100ml); 4. history of severe cardiovascular disease, hematologic diseases, etc. (such as congestive heart failure, clinically significant coronary heart disease and/or stroke, myocardial infarction and/or stroke that occurred within last six months, clinically significant arrhythmia, defined aortic aneurysm, poorly controlled hypertension (with two or more consecutive detected systolic blood pressure>160mmHg or diastolic blood pressure>100mmHg, etc.); history of long QT syndrome or prolonged QTcF interval during screening period (male QTcF = 450ms, female QTcF = 470ms); 5. severe lower respiratory tract infections requiring antibiotic treatment in the past 4 weeks; 6. Known or suspected immunodeficiency diseases, including a history of invasive opportunistic infections; 7. any other unstable clinical disease recognized by investigators, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrinic (poorly controlled diabetes patients or fasting blood glucose>10mmol/L, etc.), metabolic, hematologic, psychiatric or severe physiological dysfunction, and (a) may affect the safety of patients throughout the study process; (b) influence research results and their explanations; (c) affect the patient's ability to complete the entire study; 8. Obvious liver and kidney dysfunction. ALT, AST>2 times the upper limit of normal value; Cr levels higher than 1.5 times the upper limit of normal value (for subjects with stable chronic hepatitis B or C, if the ALT is less than 1.5 times of the upper limit of normal value during screening and meets other inclusion criteria are eligible; Subjects infected with both hepatitis B and C are not eligible for selection); 9. Active hepatitis B virus infection (hepatitis B surface antigen is positive and the HBV DNA copy number over 103/mL), hepatitis C virus infection (HCV antibody is positive) or known HIV infection or syphilis infection; 10. Patients with prothrombin time international standardized ratio (PT/INR) exceeding 1.5 × ULN during screening period 11. Allergic or contraindicated to the above-mentioned drugs in the trial; 12. Patients who have received any drugs that may affect efficacy of above-mentioned drugs within the 4 weeks prior to screening period, including systemic corticosteroids (prednisone>10mg/day or equivalent dose), other systemic immune modulators, recombinant human DNA enzymes, and any systemic antibiotics; 13. have received other immunosuppressive drugs within the 12 weeks prior to screening; which are currently within the five half-live of biological targeted drugs, including IgE monoclonal antibodies (such as omalizumab), anti-IL-5 monoclonal antibodies (such as pembrolizumab), ant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change value of forced expiratory volume in one second (FEV1) in the twelfth week; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of acute exacerbation of bronchiectasis within 12 weeks; | — |
Countries
China
Contacts
Public ContactWang Ting
West China Hospital of Sichuan University
Outcome results
None listed