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Effects of Traditional Chinese Medicine on Outcomes in Patients With AECOPD Risk Window

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ClinicalTrials.gov Identifier: NCT04851093
Recruitment Status : Recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Henan University of Traditional Chinese Medicine

Brief Summary:
This study aims to objectively evaluate the clinical efficacy and safety of Traditional Chinese Medicine in the treatment of AECOPD Risk Window, providing a basis for the formulation of TCM treatment plan with AECOPD.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: TCM granule plus conventional drug Drug: TCM placebo granule plus conventional drug Not Applicable

Detailed Description:

The incidence, mortality, and prevalence of chronic obstructive pulmonary disease (COPD) are high, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death worldwide. Acute exacerbations of COPD (AECOPD) are important events in the management of COPD because they negatively impact health status, readmission, and disease progression.

Due to the non-random and non-accidental occurrence of AECOPD,with acute exacerbations occurring mainly in a centralized period after an acute exacerbation, and wide open to attack easily in this period, we call this "highly dangerous period" as "AECOPD Risk Window". The AECOPD Risk Window has persistent systemic inflammation and unstable lung function, which increases the risk of AECOPD recurrence and readmission.

At present, western medicine has relatively mature treatment measures for COPD at the acute exacerbation stage and stable stage, however, there is no specific guidance on the medication of AECOPD Risk Window. COPD have been effectively treated with Chinese medicine for a long time. The study of syndrome regularity of "AECOPD Risk Window" provides a basis for the formulation of syndrome differentiation plan.

This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD Risk Window. 336 subjects will be randomly assigned in a 1:1 ratio to experimental group or control group for 8 weeks treatment and 18 weeks follow-up. On the basis of health education and conventional treatment, the experimental group will receive TCM granule according to the TCM syndrome, while the control group will receive TCM placebo granule according to the TCM syndrom. The primary outcomes are acute exacerbation rate in the AECOPD Risk Window, COPD Assessment Test (CAT) in the AECOPD Risk Window; and secondary outcomes are time to the first acute exacerbation, degree of acute exacerbation in the AECOPD Risk Window, acute exacerbation rate in the follow-up period, degree of acute exacerbation in the follow-up period, COPD Assessment Test (CAT) in the follow-up period, lung function, clinical symptom scores, mMRC, quality of life and index of security.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Traditional Chinese Medicine on AECOPD Risk Window Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: TCM granule plus conventional drug
The experimental group will receive three types of TCM granule and conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.
Drug: TCM granule plus conventional drug

All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.

Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.

Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.

Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.

TCM granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks.


Placebo Comparator: TCM placebo granule plus conventional drug
The control group will receive three types of TCM placebo granule and conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.
Drug: TCM placebo granule plus conventional drug

All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.

Placebo Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.

Placebo Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.

Placebo Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.

TCM placebo granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks.

The appearance, weight, color and odor of the preparation are the same as those of experimental group.

The placebo granule consists of dextrin, bitter and 5% of the TCM granule.





Primary Outcome Measures :
  1. Acute exacerbation rate in the AECOPD Risk Window [ Time Frame: in 8 weeks of the treatment period. ]
    The numbers of acute exacerbation in the AECOPD Risk Window will be recorded.

  2. COPD Assessment Test (CAT) in the AECOPD Risk Window [ Time Frame: Change from baseline CAT scores at week 0, 8 of the treatment period. ]
    The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life. It is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact).


Secondary Outcome Measures :
  1. Time to the first acute exacerbation [ Time Frame: up to week 26 during the study period. ]
    Time from the first exacerbation to the last exacerbation will be recorded.

  2. Degree of acute exacerbation in the AECOPD Risk Window [ Time Frame: in 8 weeks of the treatment period. ]
    The numbers of acute exacerbation of different severity in the AECOPD Risk Window will be recorded..

  3. Acute exacerbation rate in the follow-up period [ Time Frame: in 18 weeks of the follow-up period. ]
    The numbers of acute exacerbation in the follow-up period will be recorded.

  4. Degree of acute exacerbation in the follow-up period [ Time Frame: in 18 weeks of the follow-up period. ]
    The numbers of acute exacerbation of different severity in the follow-up period will be recorded.

  5. COPD Assessment Test (CAT) in the follow-up period [ Time Frame: Change from baseline CAT scores at week 16, 26 of the follow-up period. ]
    The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life. It is an 8-item questionnaire on a 0-5 point scale with higher values indicating greater impact of COPD. The item response values of CAT are summed to produce a single score that ranges from 0-9 (low impact), 10-20 (medium impact), 21-30 (high impact) and 31-40 (very high impact).

  6. Pulmonary function [ Time Frame: at week 0, 8 of the treatment period and at week 26 of the follow-up period. ]
    The Forced expiratory volume in one second ( FEV1), Forced Vital Capacity (FVC), FEV1% (FEV1/FVC) will be used to assess pulmonary function.

  7. Clinical symptom scores [ Time Frame: Change from baseline clinical symptom scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period. ]
    Clinical symptom scores of COPD will be used to assess symptoms. The clinical symptoms to be evaluated in this study include cough, expectoration, wheezing, chest tightness, shortness of breath, and fatigue. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin.

  8. mMRC [ Time Frame: Change from baseline mMRC scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period. ]
    The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "4" means severe dyspnea perception.

  9. SGRQ [ Time Frame: Change from baseline SGRQ scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period. ]
    The St. George's Respiratory Questionnaire (SGRQ) scores will be used to evaluate quality of life with a total score of 0-100. The higher scores will indicate the worse outcomes.

  10. mCOPD-PRO [ Time Frame: Change from baseline mPRO-COPD scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period ]
    The modified COPD Patient-Reported Outcome scale (mCOPD-PRO) will be used to assess quality of life. The mCOPD-PRO contains 27 items in three domains. mCOPD-PRO scores range from 0 to 4 with a decrease in score showing higher health status.

  11. mESQ-COPD [ Time Frame: Change from baseline mESQ-COPD scores at week 0, 8 of the treatment period and at week 16, 26 of the follow-up period. ]
    The modified Effectiveness Satisfaction Questionnaire for COPD (mESQ-COPD) will be used to assess treatment satisfaction. The mESQ-COPD contains 19 items in four domains. mESQ-COPD scores range from 0 to 4 with a decrease in score showing higher treatment satisfaction.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A confirmed diagnosis of AECOPD Risk Window;
  2. Age ranges from 40 years to 80 years;
  3. Syndrome differentiation meets criteria of qi deficiency and internal cold fluid syndrome, qi and yin deficiency and unclean phlegm heat syndrome, or lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome;
  4. Without participations in other interventional trials in the previous one month;
  5. With the informed consent signed.

Exclusion Criteria:

  1. Pregnant and lactating women;
  2. Dementia, mental disorders and reluctant partners;
  3. Complicated with heart failure (NYHA Class IV), or Serious cardiac arrhythmias, or unstable hemodynamics;
  4. Current respiratory disorders other than COPD (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function);
  5. Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation);
  6. Bedridden for various reasons;
  7. Allergic to the used medicine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851093


Contacts
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Contact: Hailong Zhang, doctor +86-0371-66248624 zhanghailong6@126.com
Contact: Jiansheng Li, doctor +86-0371-66248624 li_js8@163.com

Locations
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China, Henan
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine Recruiting
Zhengzhou, Henan, China, 450000
Contact: Hailong Zhang, doctor    +86-0371-66248624    zhanghailong6@126.com   
Sponsors and Collaborators
Henan University of Traditional Chinese Medicine
Investigators
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Study Chair: Jiansheng Li, doctor The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
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Responsible Party: Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04851093    
Other Study ID Numbers: TCM for AECOPD Risk Window
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Henan University of Traditional Chinese Medicine:
Chronic Obstructive Pulmonary Disease
Acute Exacerbation Risk Window
Traditional Chinese Medicine
Randomized Controlled Trial
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases