Moderate to severe chronic obstructive pulmonary disease (COPD)
Conditions
Sponsors
Shenzhen People's Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and follow the protocol requirements, voluntarily participate in the trial and sign the written informed consent form (ICF); 2. Age 40~85 years old (inclusive) at the time of signing ICF, gender is not limited; 3. Body mass index (BMI) >=16 kg/m^2; 4. Diagnosis of COPD according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD, 2025 edition), and medical records or relevant records at screening indicating a history of COPD >=12 months; 5. At screening, the forced expiratory volume (FEV1)/forced vital capacity (FVC) in the first second after inhalation of bronchodilator was =30% predicted and =10 pack-years at screening; Note: Number of years of packaging = (number of cigarettes per day/20 cigarettes) × number of years of smoking; Current smokers refer to subjects who have quit smoking for = 2 moderate COPD exacerbations (AECOPD) or > within 12 months prior to screening =1 severe AECOPD; Of these, at least 1 eligible exacerbation occurred when the subject received ICS/LAMA/LABA (or LAMA/LABA if ICS contraindicated); Note: (1) Moderate AECOPD refers to a moderate acute exacerbation that requires treatment with systemic glucocorticoids with or without antimicrobial drugs and is documented by the investigator; (2) Severe AECOPD refers to a severe acute exacerbation that requires hospitalization or intensive care unit (ICU) treatment, emergency observation treatment >for 24 hours, and is recorded by the investigator; (3) previous exacerbations should have occurred while receiving stable drug therapy, rather than due to treatment interruption or dose reduction; 8. Have medical records or relevant records showing that the use of background triple therapy (ICS LABA LAMA) > = 3 months before randomization and keep the dose stable > = 1 month, if there are contraindications to ICS, the use of LABA LAMA is allowed; Note: (1) Changes or switching between individual ingredients or devices are allowed as long as the subject remains on the same type of therapy at an equivalent dose; (2) short-term changes in the underlying treatment regimen during an acute exacerbation of COPD are acceptable; (3) regular use of short-acting anticholinergic drugs (at least 3 times a day) will be considered equivalent to LAMA; (4) If the subject is receiving any oral maintenance therapy for COPD (such as theophylline, roflumilast, montelukast, = 300 cells/microliter; 10. Female subjects of childbearing potential and male subjects (and their female partners) must take highly effective contraceptive measures, no childbearing, sperm donation, and egg donation plans for at least 3 months from the screening period to the end of the last trial drug administration.
Exclusion criteria
Exclusion criteria: 1. The subject is judged by the investigator to have other active or clinically significant respiratory diseases other than COPD, and participation in the study will affect the safety or research evaluation of the subject, such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary interstitial disease, cystic fibrosis, bronchiolitis obliterans or other active lung diseases; Note: Active tuberculosis: based on clinical symptoms, chest imaging results and/or contact history, the subject may have active Mycobacterium tuberculosis (TB) infection (there is evidence that the previous active tuberculosis infection has been adequately treated and can be enrolled after evaluation by the investigator); 2. Diagnosis of other pulmonary or systemic diseases related to peripheral blood eosinophilia; 3. Current diagnosis of asthma or history of asthma according to the Global Asthma Management and Prevention Strategy (GINA) or other recognized guidelines; 4. Diagnosis of a1-antitrypsin deficiency; 5. Cor pulmonale, and evidence of right heart failure; 6. New York Heart Association (NYHA) cardiac function class III or IV heart failure; 7. Acute myocardial infarction, transient ischemic attack (TIA) or stroke, unstable ischemic heart disease or other related cardiovascular diseases (such as pulmonary embolism, deep vein thrombosis) within 6 months prior to the screening visit, and participation in the study may put the subject at risk or affect the results of the study as judged by the investigator; 8. Combined with active parasitic infection (such as helminths) or suspected parasitic infection (those who are excluded from active infection by clinical and/or laboratory tests before randomization can be enrolled); 9. Any history of spring keratoconjunctivitis (VKC) and atopic keratonic conjunctivitis (AKC); 10. Have an active autoimmune disease, or are receiving immunosuppressive therapy for the treatment of an autoimmune disease (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.); 11. Any malignant tumor within 5 years prior to screening or present (except for basal cell carcinoma, local squamous cell carcinoma of the skin or cervical cancer in situ that has been cured =for 1 year for 1 year); 12. Other systemic diseases that, in the opinion of the investigator, are serious or unstable and may affect the subject's safety during the study and/or prevent the subject from completing the study, including but not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infection, endocrine, metabolic, hematologic and psychiatric diseases; 13. Any of the examination indicators meets the following criteria and is judged by the investigator to be unsuitable for inclusion in the study: (a) 3 times the upper limit of the reference value (ULN) > at screening or random proalanine aminotransferase or aspartate aminotransferase; (b) 2 times ULN > total prebilirubin (TBIL) at screening or randomization; (c) The white blood cell count at screening or before random is lower than the lower limit of normal, which is judged by the investigator to be clinically significant and not suitable for inclusion in the study; (d) at screening, a positive hepatitis B test result [defined as: (1) hepatitis B surface antigen (HBsAg) positive, or (2) HBsAg negative but hepatitis B core antibody (HBcAb)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The annualized incidence of moderate/severe AECOPD during the 52-week treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in pre-bronchodilator FEV1 at Week 24;Change from baseline in pre-bronchodilator FEV1; | — |
Countries
China
Contacts
Public ContactRongchang Chen
Shenzhen People's Hospital
Outcome results
None listed