NCT03428412

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
378

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Mar 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 9, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

January 19, 2018

Last Update Submit

February 4, 2018

Conditions

Pulmonary Disease, Chronic ObstructiveAcute ExacerbationMedicine, Chinese Traditional

Keywords

Chronic Obstructive Pulmonary DiseaseAcute exacerbationTraditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • Readmission due to AECOPD

    The numbers of readmission due to AECOPD in 28 Days of the followup 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.

  • +4 more secondary outcomes

Study Arms (2)

TCM plus conventional drug

EXPERIMENTAL

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

TCM placebo plus conventional drug

PLACEBO COMPARATOR

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

Interventions

TCM and conventional drugDRUG

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.

TCM plus conventional drug
TCM placebo and conventional drugDRUG

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.

TCM placebo plus conventional drug

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 31842969DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Hailong Zhang, doctor

CONTACT

86-371-66248624zhanghailong6@126.com

Jiansheng Li, doctor

CONTACT

86-371-66248624li_js8@163.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

February 9, 2018

Study Start

March 1, 2018

Primary Completion

September 30, 2019

Study Completion

December 31, 2019

Last Updated

February 9, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share