Effects of Traditional Chinese Medicine on AECOPD Patients

Effects of Traditional Chinese Medicine on AECOPD Patients: A Multi-center, Randomized, Double-blind, Controlled Trial

This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks. The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include treatment failure rate, treatment success rate, hospitalization time, hospital admission rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive; Medicine, Chinese Traditional; Acute Exacerbation
• Intervention / Treatment: Drug: TCM and conventional drug; Drug: TCM placebo and conventional drug

• Study Type: Interventional
• Enrollment (Anticipated): 378
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• A confirmed diagnosis of moderate to very severe AECOPD
• Age between 40 and 80 years
• Syndrome differentiation meets criteria of syndrome of external cold and internal fluid,syndrome of phlegm-heat congesting lung,or syndrome of phlegm-damp amassing in lung
• Without participations in other interventional trials in the previous one month
• With the informed consent signed

Exclusion Criteria:

• Pregnant and lactating women
• Dementia, mental disorders and reluctant partners
• Complicated with heart failure (NYHA Class IV), or Serious cardiac arrhythmias, or unstable hemodynamics
• Current respiratory disorders other than COPD (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function)
• Combined tumor
• Treated outside the hospital for more than 7 days
• Need to carry out invasive mechanical ventilation respiratory failure
• Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation)
• Bedridden for various reasons
• Allergic to the used medicine

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TCM plus conventional drug; The experimental group will receive three type of TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.	Drug: TCM and conventional drug; All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. The Experimental group will receive TCM according to the TCM syndrome. Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days. Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days. Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days.
PLACEBO_COMPARATOR: TCM placebo plus conventional drug; The control group will receive three type of placebo TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.	Drug: TCM placebo and conventional drug; All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD. The control group will receive TCM placebo according to the TCM syndrome. Placebo Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days. Placebo Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days. Placebo Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD Assessment Test(CAT)	Using COPD Assessment Test ( CAT) to asses the impact of AECOPD on a person's life, and how this changes over time.	Change from baseline CAT score at day 0, 14 of the treatment phase, at day 14, 28 of the follow-up phase.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failure rate		The numbers of treatment failure at day 14 of the treatment phase.
Treatment success rate		The numbers of treatment success at day 14 of the treatment phase.
Length of hospital stays	length hospital stays will be recorded.	The length hospital stays in 14 Days of the treatment phase
Readmission due to AECOPD	Readmission due to AECOPD will be recorded.	The numbers of readmission due to AECOPD in 28 Days of the followup phase.
Intubation rate	Intubation will be recorded.	The numbers of intubation at day 4,7,10，14 of the treatment phase, at day 14, 28 of the follow-up phase.
Mortality		The numbers of mortality at day 14 of the treatment phase and day 28 of the follow-up phase.
Dyspnea	Using modified Medical Research Council (mMRC) to asses the dyspnea of COPD, and how this changes over time.	Change from Baseline in the mMRC at day 0, 4, 7, 10,14 of the treatment phase, at day 14, 28 of the follow-up phase.
SF-36	Using the MOS item short from health survey (SF-36) to asses the impact of COPD on a person's life, and how this changes over time.	Change from Baseline in the SF-36 at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.
COPD-PRO	Using the COPD patient reported outcome scale (COPD-PRO) to asses the impact of COPD on a person's life, and how this changes over time.	Change from Baseline in the COPD-PRO at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Zhang H, Li J, Yu X, Li S, Wang H, Ruan H, Si Y, Xie Y, Wang M. Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial. Trials. 2019 Dec 16;20(1):735. doi: 10.1186/s13063-019-3772-y.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2018
• Primary Completion (ANTICIPATED): September 30, 2019
• Study Completion (ANTICIPATED): December 31, 2019

Study Registration Dates

• First Submitted: January 19, 2018
• First Submitted That Met QC Criteria: February 4, 2018
• First Posted (ACTUAL): February 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Traditional Chinese medicine; Acute exacerbation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TCM for 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