Chronic obstructive pulmonary disease with cardiovascular underlying diseases
Conditions
Interventions
LAMA/LABA combination therapy group:Administer glycopyrronium bromide/formoterol fumarate 7.2µg/5.0 µg twice daily (morning and evening) via metered-dose inhaler (MDI).
ICS/LAMA/LABA combination therapy group:Budesonide/Glycopyrronium/Formoterol (160µg/7.2µg/4.8µg) MDI, 2 inhalations BID
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Capable of reading, understanding, and signing the informed consent document; 2. Eligible subjects must be outpatient males or females aged 40 years or above; 3. Participants with current or past tobacco use (>=10 pack-years); 4. After bronchiectasis, FEV1 accounted for 30 % -50 % or 50 % -80 % of the predicted value, and FEV1 / FVC = 2 points ; 6. Patients meeting the 2023 GOLD case definition of COPD (post-bronchodilator FEV1/FVC <0.70 with compatible symptoms); 7. Lung function classification was GOLD2-3 ; 8. The comprehensive assessment of disease severity during the stable period is Group B; 9. Diagnosis of cardiovascular diseases, such as : hypertension, peripheral arterial disease, stroke, coronary artery disease, previous heart failure, previous myocardial infarction, pulmonary heart disease, arrhythmia ( such as atrial fibrillation ), venous thromboembolism, pulmonary vascular disease, valvular heart disease, rheumatic heart disease, congenital heart disease, cardiomyopathy, ischemic heart disease, aortic and peripheral vascular disease.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women, or women of childbearing potential planning pregnancy during the study period; 2. Subjects with a current diagnosis of asthma (COPD patients with a history of asthma are also excluded from this study); 3. COPD patients with a1-antitrypsin deficiency as the underlying etiology; 4. Subjects with comorbid respiratory diseases, including but not limited to: active tuberculosis, lung cancer, severe bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung disease, or other active pulmonary diseases. 5. Presence of unresolved respiratory infections (e.g., pneumonia, lung abscess) within 7 days prior to enrollment; 6. History of lung volume reduction surgery (LVRS) or long-term oxygen therapy (LTOT). 7. Chronic oral corticosteroid therapy; 8. Subjects with clinically significant abnormalities in neurological, psychiatric, renal, hepatic, immune, gastrointestinal, genitourinary, musculoskeletal, dermatological, sensory, endocrine (including uncontrolled diabetes or thyroid disorders), or hematological systems. Significance is defined as any condition that, in the investigator's judgment, would: (1) Place the subject at undue risk by participation, or (2) Compromise efficacy/safety analyses if the condition worsens during the study. 9. History of hypersensitivity to any anticholinergic/muscarinic receptor antagonist or ß2-agonist, or comorbid conditions such as glaucoma, prostatic hyperplasia, or bladder neck obstruction that, in the investigator's judgment, contraindicate study participation. 10. Poor compliance: Subjects at risk of non-adherence or unable to comply with study procedures, including those with severe physical debilitation, disabilities, or geographical constraints limiting clinic visits.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| major adverse cardiovascular events (MACE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Moderate to severe acute exacerbation of COPD;Death caused by any reason;cardiovascular adverse events (CVAEs);Other adverse events excluding cardiovascular events; | — |
Countries
China
Contacts
Public ContactGou shuliang
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed