Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD

Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD：A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Exacerbation Of Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe; Drug: Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 468
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hailong Zhang, doctor; Phone Number: +86-0371-66248624; Email: zhanghailong6@126.com
• Study Contact Backup: Name: Hailong Zhang, doctor; Phone Number: +86-0371-66211586; Email: zhanghailong6@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chinese medicine granules plus western medicine treatment; On the basis of conventional western medicine treatment, the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days.	Drug: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe; On the basis of conventional treatment of western medicine,the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days.
Placebo Comparator: Chinese medicine granules placebo plus western medicine treatment; On the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days.	Drug: Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo; On the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure rate	The number of treatment failures in both groups during the study period was measured. Treatment failure was defined as the following: (1) the need for or receipt of tracheal intubation or invasive mechanical ventilation during hospitalization, or (2) the need for or transfer to an intensive care unit during hospitalization, or (3) the duration of hospitalization for the current acute exacerbation of COPD for more than 14 days, or (4) death during hospitalization or within 30 days after discharge, or (5) readmission for an acute exacerbation of COPD within 30 days after discharge.	During the 10 days treatment period and the 3 months follow-up period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The COPD Assessment Test(CAT)	The COPD Assessment Test (CAT) is an 8-item questionnaire that assesses health status in patients with COPD. The questionnaire uses a 0-5 point scale, with higher values indicating a greater impact of COPD on the patient.	Changes in baseline CAT scores at day 10 of the treatment period and at 1 and 3 months of follow-up.
The number and severity of acute exacerbations	The number and severity of acute exacerbations during the follow-up period.	Within 3 months of follow-up period.
Readmission rate of acute exacerbations	The number of readmissions due to acute exacerbations during the follow-up period.	Within 3 months of follow-up period.
The time to the first exacerbation of COPD	The time to the first COPD exacerbation during the study period.	Within 3 months of follow-up period.
Dyspnea score	The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea. The mMRC scale is a 4-point (0-4) scale. "0" means no dyspnea perception, "4" means severe dyspnea perception.	Changes in baseline mMRC scores at days 4, 7, and 10 of the treatment period and at 1 and 3 months of follow-up.
COPD Acute exacerbation tool (EXACT) score	The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) is a questionnaire that assesses symptoms in patients with COPD. The questionnaire is on a scale from 0 to 5, with higher values indicating a greater impact of COPD on the patient.	0 and 10 days in the treatment period, 1 and 3 months in the follow-up period.
Length of hospital stay	Through study /treatment phase completion,an average of 10 days.	During the 10 days treatment period and the 3 months follow-up period.
Antibacterial application time	The antibacterial application time of each group of subjects was counted.	During the 10 days treatment period and the 3 months follow-up period.
Endotracheal intubation rate	The number of endotracheal intubation cases in the two groups during the treatment period was calculated.	In 10 days of the treatment period.
Case fatality rate	The number of deaths due to AECOPD in the two groups during the study period was counted.	During the 10 days treatment period and the 3 months follow-up period.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Collaborators: Jiangsu Province Hospital of Traditional Chinese Medicine; Peking University Third Hospital; Chengdu University of Traditional Chinese Medicine; Qingdao Haici Hospital; Shenzhen Hospital of Southern Medical University; First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine; Xiangyang Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CM for Severe AECOPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No