Acute exacerbation of chronic obstructive pulmonary disease
Conditions
Interventions
Experimental group:Human placental lipopolysaccharide injection + basic treatment
Control group:Human placental lipopolysaccharide injection placebo + basal therapy
Sponsors
The Second Xiangya Hospital, Central South University
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Participants must be at least 40 years old and of any gender at the time of signing the informed consent form; 2. COPD diagnosis records for at least one year prior to enrollment; 3. Complies with the latest GOLD 2024 guidelines for the definition of acute exacerbation of COPD (Attachment 1); 4. The subjects are informed, voluntarily sign the informed consent form, and agree to participate in all visits, examinations, and treatments according to the requirements of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Currently suffering from any of the following diseases: active pulmonary tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, bronchiolitis obliterans, sarcoidosis (sarcoidosis), etc., or clinically significant pulmonary fibrosis, pulmonary arterial hypertension, interstitial lung disease, active bronchiectasis that have been determined by the research doctor to pose a safety risk and/or affect the analysis of research results for patients participating in this trial. 2. Any unstable disease, including but not limited to: cardiovascular, gastrointestinal, liver, kidney, nervous system, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, major limb dysfunction or cognitive impairment, and the researcher believes that: a. Affects the safety of participants throughout the entire study period. b. Impact research results and their explanations. c. Obstructing the subjects and causing them to be unable to complete the entire study process and/or comply with the study visit schedule and study steps. 3. Before randomization, there were still other diseases that required systemic anti infective treatment, except for COPD related infections. 4. Unstable cardiovascular diseases (including but not limited to: ischemic heart disease, arrhythmia, cardiomyopathy, unstable moderate to severe heart failure (NYHA III-IV grade and/or LVEF2ULN, or TBIL>2ULN (unless caused by Gilbert's disease). Note: If the researcher considers that the subject has no active liver disease and meets other inclusion criteria, transient elevation of ALT/AST/TBIL may also be acceptable for regression before randomization. 7. History of active severe inflammatory bowel disease or colitis within the year prior to enrollment, or unexplained diarrhea within the 4 weeks prior to randomization. 8. Known history of immunodeficiency, including testing positive for HIV-1 or HIV-2. 9. History or treatment of positive hepatitis B or C, except for cured hepatitis C. a. HBsAg test positive. b. Positive anti HBc test: Subjects who test positive for anti HBc antibodies but negative for HBsAg can be enrolled if their HBV DNA test result is negative. c. Positive anti hepatitis C antibody test: Subjects who test positive for anti hepatitis C antibodies can be enrolled if their hepatitis C virus RNA test result is negative and they do not have cirrhosis. 10. Patients with malignant tumors currently or within the past 5 years, excluding basal cell carcinoma and squamous cell carcinoma of the skin that have undergone appropriate non-invasive treatment, as well as cervical carcinoma in situ that has been successfully treated for more than 1 year before enrollment. Suspected malignant tumor or undetermined tumor. 11. Researchers or qualified designated personnel believe that the subjects have evidence of active pulmonary tuberculosis (TB). Subjects who have recently (within 2 years) tested positive for purified protein derivatives (PPD) or QuantiFERON TB for the first time or newly discovered positive subjects are required t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of recurrent acute exacerbations of chronic obstructive pulmonary disease within 12 months after treatment in both groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in 4 pulmonary function indicators (FEV1, FVC) from baseline were investigated;Each visit Chronic obstructive pulmonary Disease Assessment Test (CAT) total score, CCQ total score compared to baseline change;Times of inhaled salbutamol aerosol use during each visit treatment period;Serum levels of IL-2, IL-4, IL-10, IFN-?, TNF-a, IL-8, IL-1ß, and IL-6 changed from baseline after each visit;The levels of IgA, IgG, IgM, CD3+, CD4+, CD8+, CD45+, total T lymphocytes and NK cells were changed from baseline;Incidence of recurrent acute exacerbations of COPD in patients treated for 1 year.; | — |
Countries
China
Contacts
Public Contactwu shangjie
The Second Xiangya Hospital, Central South University
Outcome results
None listed