Moderate to severe chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Control group:Subcutaneous injection of placebo solution
Experimental group:XH001 injection for subcutaneous injection
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The participants in the trial can understand the procedures and methods of this study, are willing to sign the informed consent form, strictly abide by the clinical research protocol to complete this study, and can independently complete the relevant research questionnaires. 2. When signing the informed consent form, the age of the participants must be >= 40 years old and = 16.0 kg/m^2. 4. The participants diagnosed with COPD for >= 12 months (diagnosed according to GOLD 2024) and meeting the following criteria are eligible for the trial: current smokers or former smokers who have quit smoking, and the smoking history must be >= 10 pack-years (1 pack-year is calculated as the average daily smoking count × years / 20; for example, 1 pack-year = 20 cigarettes per day in one year, or 10 cigarettes per day in two years). There must be moderate to severe airflow limitation (FEV1/FVC after bronchodilator treatment = 30% and = 2 moderate or >= 1 severe acute exacerbation within one year before screening: moderate acute exacerbation is defined as the need to use systemic glucocorticoids (intramuscular injection, intravenous injection or oral) and/or antibiotics (but the use of antibiotics itself does not meet the criteria for moderate acute exacerbation, unless there is a record indicating that the use of antibiotics is necessary for the treatment of COPD symptom deterioration); chronic obstructive pulmonary disease acute exacerbation (AECOPD) requiring hospitalization or observation in the emergency room/first aid institution for > 24 hours after two necessary moderate acute exacerbations; the participants who received inhaled background maintenance therapy [triple therapy (ICS + LABA + LAMA) or dual therapy (LABA + LAMA or ICS + LABA)] for >= 3 months before randomization, and the treatment dose was stable at least 1 month before signing the ICF and during the screening period. 5. The total blood eosinophil count during the screening period must be >= 150/µL. 6. Women with reproductive potential and their male partners, and male participants and their female partners, agree to use an effective contraceptive method during the study period and within 6 months after the last medication administration, without plans for fertility, sperm donation, or egg donation (see Appendix 1: Contraceptive measures, definition of reproductive potential, and contraceptive requirements).
Exclusion criteria
Exclusion criteria: 1. Individuals with other respiratory system diseases besides COPD, including: those currently diagnosed with asthma or having a history of asthma according to the Global Initiative for Asthma Management and Prevention (GINA) or other recognized guidelines; those diagnosed with a1-antitrypsin deficiency; other concurrent active or clinically significant respiratory diseases that have a significant impact on the study: such as active tuberculosis, lung cancer (including suspicious malignant pulmonary nodules [4 categories]), bronchiectasis, sarcoidosis, pulmonary fibrosis, interstitial lung disease, cystic fibrosis, obliterative bronchiolitis, pulmonary hypertension, etc.; 2. Within 4 weeks before screening and before randomization, having AECOPD (including mild, moderate, and severe; the definitions of moderate and severe AECOPD are provided in item 3 of the inclusion criteria) and/or respiratory infections; 3. Signs and/or symptoms of pulmonary heart disease and/or right ventricular failure; 4. Hypercapnia requiring bilevel airway positive pressure ventilation (BiPAP); 5. Currently receiving or planning to start long-term oxygen therapy (daily oxygen inhalation > 15 hours) or mechanical ventilation during the study; 6. Participants who have participated in or plan to participate in an enhanced COPD rehabilitation program within 4 weeks before screening (trial participants in the maintenance stage of the rehabilitation plan may be considered for inclusion); 7. Planning to undergo lung resection or lung volume reduction surgery or having a history of such surgery; 8. Abnormal lipid indicators of grade >= 2 (NCI-CTCAE v6.0) (note to exclude the influence of physiological factors such as diet); 9. Complicated with autoimmune diseases and requiring systemic immunosuppressant treatment (such as rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis); 10. Known or suspected history of immunosuppressive diseases, including invasive opportunistic infections (such as tuberculosis (TB), histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis pneumonia, aspergillosis), even if the infection has been resolved; or according to the investigator's judgment, there are abnormal, frequent, or long-term infections; 11. Confirmed active parasitic infection; suspected parasitic infection or having a high risk of infection, unless the active infection has been excluded by clinical assessment and (if necessary) laboratory assessment before randomization; 12. Confirmed within 4 weeks before screening or during screening that they have acute or chronic infections that require systemic antibiotics, antiviral drugs, antifungal drugs, antiparasitic drugs or antiprotozoal drugs treatment; 13. Within 12 weeks before screening, having undergone grade 3 or 4 surgery (as defined by the "Management Measures for Surgical Grades in Medical Institutions": surgical grade management) (excluding biopsy); or planning to undergo surgery that requires general anesthesia or hospitalization for > 1 day during the study; 14. Other serious diseases as determined by the investigator that may affect the patient's participation in this study, including but not limited to: diseases that severely affect survival, uncontrolled diabetes, renal insufficiency requiring dialysis, liver function at Child-Pugh B/C grade, demyelinating diseases, neurological and psychological diseases, etc.; 15. Having clinically signif
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in post-bronchodilator FEV1 (mL) at Week 28;The incidence, severity (based on NCI-CTCAE v6.0), and relationship to the investigational product of treatment-emergent adverse events (TEAEs); changes in various safety assessments before and after; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change from baseline in post-bronchodilator FEV1 (%) at Weeks 2, 4, 8, 12, 16, 20, 24, 28, and 32;Change from baseline in forced expiratory flow (FEF) 25%-75% (L/s) and percentage change (%) at Week 28;Change from baseline in post-bronchodilator FEV1 (mL) at Weeks 2, 4, 8, 12, 16, 20, 24, and 32;Annualized rate of moderate-to- COPD exacerbations during the 28-week treatment period;Change from baseline in pre-bronchodilator FEV1 (mL) and percentage change (%) at Week 28;Proportion of participants with an improvement in SGRQ total score of =4 points at Weeks 12 and 28;Change from baseline in Evaluating Respiratory Symptoms (E-RS) score at Weeks 4, 8, 12, 16, 20, 24, 28, and 32;Change from baseline in COPD Assessment Test (CAT) score at Weeks 4, 8, 12, 16, 20, 24, 28, and 32;Annualized rate of moderate-to-severe COPD exacerbations during the 28-week treatment period;Change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Weeks 4, 8, 12, 16, 20, 24, 28, and 32;Time to first moderate-to-severe COPD exacerbation during the 28-week treatment period;Time to first severe COPD exacerbation requiring emergency department visit or hospitalization during the 28-week treatment period; | — |
Countries
China
Contacts
Public ContactTing Yang
China-Japan Friendship Hospital
Outcome results
None listed