Influenza virus-associated acute exacerbation of chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Control group:Basic treatment+Xuanfei Baodu particle simulator
Treatment group:Basic treatment+Xuanfei Baidu Granules
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be able to understand the procedures and methods of this study, be able to communicate well with the investigator, be willing to strictly abide by the clinical trial protocol to complete this trial, and voluntarily sign a written informed consent form; 2. Age 40-75 years old (including boundary value), male or female; 3. Meet the diagnostic criteria for COPD in GOLD in 2024, and the severity of airflow limitation is GOLD grade 1~3 (FEV1 accounts for >=30% of the predicted value), and the acute attack and the course of the disease is within 3 days; 4. Positive influenza virus test (influenza virus antigen test or influenza virus nucleic acid test (test results within the past 3 days are acceptable)); 5. Meet the TCM phlegm-heat and lung syndrome differentiation standards; TCM Diagnostic Criteria: (1) Coughing, wheezing, and movement are aggravated; (2) The sputum is viscous, or white or yellow; (3) fever (body temperature (axillary temperature) >=37.3°C); (4) thirst; (5) constipation; (6) The tongue is red, or the tongue coating is yellow or yellow and greasy, or the number of pulses or slippery numbers. Possess 3 items (1), (2), (3), and add 2 items (4), (5), and (6).
Exclusion criteria
Exclusion criteria: 1. Other concomitant active or clinically significant respiratory diseases that have a significant impact on the study: such as subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, pulmonary interstitial disease, cystic fibrosis, bronchiolitis obliterans or other active lung diseases; 2. Those with a history of bronchial asthma in the past; 3. Blood WBC >11.0×10^9/L or neutrophil >75% and C-reactive protein exceeds the normal range; 4. Combined with other serious and/or uncontrollable important organs or unstable systemic diseases, including but not limited to uncontrolled diabetes mellitus, unstable angina, cerebrovascular accident or transient cerebral ischemia (within 6 months before screening), myocardial infarction (within 6 months before screening), severe congestive heart failure (NYHA>= Grade 3), uncontrolled hypertension, uncontrolled active infection, hepatic, renal or other severe metabolic disease, severe gastrointestinal disease, any psychiatric illness that affects the ability to follow study procedures; 5. Previous pulmonary resection, or lung volume reduction surgery within 12 months prior to screening; 6. Use of long-term oxygen therapy (oxygen therapy duration > 15h/d) or mechanical ventilation; 7. Have a history of malignancy within the past 5 years, or are currently being evaluated for potential malignancy; 8. Patients who are allergic to the components of the study drug, allergic constitution or those who have been allergic to multiple drugs in the past; 9. Patients with mental illness and severe depression; Alcohol-dependent or with a history of drug abuse within the past year; 10. Pregnant or lactating women and those who are planning to give birth during or within 3 months after taking the drug; 11. Patients who are unable to swallow oral preparations and/or have gastrointestinal disorders that may interfere with the absorption of the study drug; 12. Those who have participated in other interventional clinical studies within 4 weeks before the trial; 13. Patients who are considered by other investigators to be inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference between the two groups in the change from baseline in BCSS(Breathlessness, Cough, and Sputum Scale ) score at 7 days ±1 day after medication;For subjects with positive sputum culture, the negative conversion rate upon retesting at 7 days ±1 day after medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fever resolution rate at 7 days ±1 day after medication;Change from baseline in BCSS (Breathlessness, Cough, and Sputum Scale )score at 14 days ±1 day after medication in subjects with resolved fever;Change from baseline in pulmonary function indicators (FEV1, FVC, IC, RV, RV/TLC, etc.) before and after treatment;Change from baseline in TCM syndrome scores during treatment;Time to fever resolution and fever resolution rate during treatment;Change from baseline in CAT (Chronic obstructive pulmonary disease Assessment Teast)score during treatment;Negative conversion rate of influenza virus nucleic acid detection at 7 days ±1 day after medication;Negative conversion rate of influenza virus nucleic acid detection at 14 days ±1 day after medication; | — |
Countries
China
Contacts
Public ContactLiu Qingquan
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed