Effects of Traditional Chinese Medicine on AECOPD Patients

Phase 3

• Conditions: Pulmonary Disease, Chronic Obstructive; Acute Exacerbation; Medicine, Chinese Traditional
• Interventions: Drug: TCM placebo and conventional drug; Drug: TCM and conventional drug

• Registration Number: NCT03428412
• Lead Sponsor: Henan University of Traditional Chinese Medicine

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study First Submitted: 2018-01-19
• Study First Submitted QC: 2018-02-04
• Last Update Submitted: 2018-02-04
• Study First Posted: 2018-02-09
• Last Update Posted: 2018-02-09
• Study Start: 2018-03-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 378

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM placebo plus conventional drug	TCM placebo and 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.
TCM plus conventional drug	TCM and 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	The length hospital stays in 14 Days of the treatment phase	length hospital stays will be recorded.
Readmission due to AECOPD	The numbers of readmission due to AECOPD in 28 Days of the followup phase.	Readmission due to AECOPD will be recorded.
Mortality	The numbers of mortality at day 14 of the treatment phase and day 28 of the follow-up phase.
Intubation rate	The numbers of intubation at day 4,7,10，14 of the treatment phase, at day 14, 28 of the follow-up phase.	Intubation will be recorded.
Dyspnea	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.	Using modified Medical Research Council (mMRC) to asses the dyspnea of COPD, and how this changes over time.
SF-36	Change from Baseline in the SF-36 at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.	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.
COPD-PRO	Change from Baseline in the COPD-PRO at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.	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.