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Simvastatin Combined with Conventional Therapy on Symptoms, Quality of Life, and Inflammatory Response in AECOPD Patients and Its Safety Evaluation: A Multicenter, Randomized, Open-Label Study

Simvastatin Combined with Conventional Therapy on Symptoms, Quality of Life, and Inflammatory Response in AECOPD Patients and Its Safety Evaluation: A Multicenter, Randomized, Open-Label Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124697
Enrollment
Unknown
Registered
2026-05-15
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

Simvastatin group:Simvastatin tablets, 20 mg orally, once daily.
Control group:Conventional treatment was administered according to the relevant contents of the Guidelines for the Diagnosis and Management of Chronic Obstructive P

Sponsors

The Second Affiliated Hospital of the Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation with signed informed consent; 2. Aged 40–80 years at the time of informed consent signing, either sex; 3. Current smokers or former smokers; 4. Patients with a prior diagnosis of COPD who are hospitalized due to acute exacerbation of COPD in respiratory or general internal medicine wards; 5. Hemodynamically stable within 24 hours of admission, with PaCO2 <= 70 mmHg; 6. No statin use for at least 6 months prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Patients with extremely severe condition requiring invasive mechanical ventilation; 2. Patients with other active pulmonary diseases prior to enrollment, such as active tuberculosis, lung cancer, pulmonary embolism, sarcoidosis, interstitial lung disease, primary pulmonary hypertension, and bronchial asthma; 3. Patients with severe hepatic or renal insufficiency, cardiac insufficiency, or other conditions requiring corresponding drug treatment; 4. Patients with unstable ischemic heart disease, myocardial infarction, or cerebrovascular accident within 6 months prior to enrollment, or those with acute coronary syndrome within 3 months, or who have undergone percutaneous coronary intervention or coronary artery bypass grafting; 5. Patients with psychiatric disorders, intellectual disability, poor motivation, drug or alcohol abuse, or other conditions that would limit participation in this study; 6. Participation in other clinical trials within 4 weeks prior to enrollment; 7. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period, or women of childbearing potential not using effective contraception (urine HCG test required for women of childbearing age); 8. Patients receiving non-invasive or invasive mechanical ventilation that precludes oral medication administration; 9. Current use of macrolide antibiotics, azole antifungal agents, or amlodipine; 10. Patients with known hypersensitivity to simvastatin; 11. Patients on long-term statin therapy; 12. Patients deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Differences in COPD symptom assessment (mMRC, CAT scores), quality of life score differences (Saint George's Respiratory Questionnaire), and 6-minute walk test;

Secondary

MeasureTime frame
Blood gas analysis parameters (PaO2, PaCO2, oxygenation index), changes in peak expiratory flow rate, changes in inflammatory markers (IL-17, IL-10, IL-8, IL-6, TNF-a, IFN-?, P-selectin, CRP), and drug safety indicators;

Countries

China

Contacts

Public ContactXu Zhi

The Second Affiliated Hospital of the Army Medical University

xu_zhi999@163.com+86 23 68774406

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 22, 2026