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

Acute Exacerbation Of Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455670
• Other study ID #: CM for Severe AECOPD
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 31, 2024
• Est. completion date: October 31, 2027

Study information

• Verified date: June 2024
• Source: Henan University of Traditional Chinese Medicine
• Contact: Hailong Zhang, doctor
• Phone: +86-0371-66211586
• Email: zhanghailong6[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 468
• Est. completion date: October 31, 2027
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Exacerbation Of Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine	Chengdu University of Traditional Chinese Medicine, First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese Medicine, Peking University Third Hospital, Qingdao Haici Hospital, Xiangya Hospital of Central South University, Xiangyang Hospital of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.