Clinical trial NCT06455670: Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD
Official title: Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD：A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Exacerbation Of Chronic Obstructive Pulmonary Disease
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Peking University Third Hospital
name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Chengdu University of Traditional Chinese Medicine
name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
name: Shenzhen Hospital of Southern Medical University
name: Qingdao Haici Hospital
name: Xiangyang Hospital of Traditional Chinese Medicine
First posted: 2024-06-12
Enrollment: 468
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effects of Chinese Medicine on patients with severe AECOPD, and to provide a basis for the establishment of integrated CM and Western medicine diagnosis and treatment scheme for patients with severe AECOPD.

Detailed description: Aiming at the key problems such as the lack of high-quality clinical research evidence of Chinese medicine in the prevention and treatment of severe AECOPD, this study adopted a multi-center, randomized, double-blind, placebo-controlled parallel trial design, taking 468 severe AECOPD patients as the research object, to evaluate the clinical efficacy and safety of Chinese medicine combined with western medicine in the treatment of severe AECOPD. To establish an integrated Chinese and western medicine diagnosis and treatment plan to reduce the treatment failure rate of severe AECOPD patients, and to form high-level evidence-based evidence.

Eligibility criteria: Inclusion Criteria:

1. Patients with severe AECOPD.;
2. Age 40-80 years old;
3. Chinese medicine diagnosis consistent with external cold and internal drink syndrome, or phlegm-heat congestion of the lungs syndrome, or phlegm turbidity obstruction of the lungs syndrome;
4. Voluntarily accept the treatment and sign the informed consent form;

Exclusion Criteria:

1. Pregnant and lactating women.
2. delirious, dementia, various mental patients and other people who cannot communicate normally.
3. Patients with severe cardiac insufficiency (NYHA grade IV), malignant arrhythmia and hemodynamic instability.
4. Patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation.
5. Complicated with bronchiectasis, active tuberculosis, severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, etc., serious kidney disease including dialysis, kidney transplantation, etc.), pneumonia, HIV infection or immunosuppressive state, advanced malignant tumor, etc.
6. long-term bedridden patients for various reasons.
7. Out-of-hospital treatment for more than 3 days.
8. Participate in other drug clinical investigators within 1 month before enrollment.
9. Allergic to therapeutic drugs.

Primary outcomes:
measure: Treatment failure rate
timeFrame: During the 10 days treatment period and the 3 months follow-up period.
Secondary outcomes:
measure: The COPD Assessment Test(CAT)
timeFrame: Changes in baseline CAT scores at day 10 of the treatment period and at 1 and 3 months of follow-up.
measure: The number and severity of acute exacerbations
timeFrame: Within 3 months of follow-up period.
measure: Readmission rate of acute exacerbations
timeFrame: Within 3 months of follow-up period.
measure: The time to the first exacerbation of COPD
timeFrame: Within 3 months of follow-up period.
measure: Dyspnea score
timeFrame: Changes in baseline mMRC scores at days 4, 7, and 10 of the treatment period and at 1 and 3 months of follow-up.
measure: COPD Acute exacerbation tool (EXACT) score
timeFrame: 0 and 10 days in the treatment period, 1 and 3 months in the follow-up period.
measure: Length of hospital stay
timeFrame: During the 10 days treatment period and the 3 months follow-up period.
measure: Antibacterial application time
timeFrame: During the 10 days treatment period and the 3 months follow-up period.
measure: Endotracheal intubation rate
timeFrame: In 10 days of the treatment period.
measure: Case fatality rate
timeFrame: During the 10 days treatment period and the 3 months follow-up period.
Other outcomes:
Locations:
Study officials:
References: