Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure

January 5, 2020 updated by: Fengcuiling, Peking University People's Hospital

Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure: A Randomized, Double-blind, Placebo Controlled Trial

This study aims to establish the treatment scheme of Yiqi Huoxue Huatan granule for chronic obstructive pulmonary disease (COPD) with chronic respiratory failure (CRF), reducing mortality, improving quality of life and forming high quality evidence.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

COPD is a highly prevalent disease, 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. COPD complicated by CRF is serious and has a high mortality rate. At present, ideal and effective treatment is inadequate. Traditional Chinese medicine (TCM) has some potential in improving outcomes in COPD with CRF.

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Yiqi Huoxue Huatan granule on reducing mortality and improving quality of life in COPD with CRF. After a 14-day run-in period, 372 subjects will be randomly assigned to treatment group or control group for 52-week treatment, followed by 52-week follow-up. The primary outcomes are all-cause mortality and frequency of acute exacerbation of COPD. The secondary outcomes include clinical symptoms, COPD assessment test (CAT), arterial blood gas analysis, pulmonary function and duration of mechanical ventilation. Safety will also be assessed.

Study Type

Interventional

Enrollment (Anticipated)

372

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Changping TCM Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 stable COPD;

    • Arterial blood gas analysis meets criteria of PaO2 < 60mmHg and PaCO2 > 50mmHg during quiet breathing at sea level;
    • Syndrome differentiation meets criteria of Qi deficiency, blood stasis and phlegm turbidity obstructing orifice syndrome；
    • Age ranges from 40 years to 80 years;
    • With informed consent signed.

Exclusion Criteria:

  • • CRF resulting from other respiratory diseases, such as bronchiectasis, pulmonary cystic fibrosis, lung cancer, etc.;

    • Acute exacerbation of CRF；
    • Patients with severe cardiovascular and cerebrovascular diseases;
    • Pregnant and lactating women;
    • Patients with psychiatric disorders；
    • Patients with diabetes;
    • Patients who have participated in other clinical studies in the past 4 weeks;
    • Patients who have experienced one or more acute exacerbation of COPD in the past 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yiqi Huoxue Huatan granule plus Western medicine
Patients in this arm will receive Yiqi Huoxue Huatan granule in addition to Western medicine.
Drug: Yiqi Huoxue Huatan granule
Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
Other Names:
  • Tiotropium Bromide Powder for Inhalation
  • Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation
Placebo Comparator: Placebo Yiqi Huoxue Huatan granule plus Western medicine
Patients in this arm will receive placebo Yiqi Huoxue Huatan granule in addition to Western medicine.
Drug: Placebo Yiqi Huoxue Huatan granule
Placebo Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
Other Names:
  • Tiotropium Bromide Powder for Inhalation
  • Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Up to week 52 of the follow-up phase.
All-cause mortality will be calculated in this study.
Up to week 52 of the follow-up phase.
Frequency of acute exacerbation of COPD
Time Frame: Up to week 52 of the follow-up phase.
Frequency of acute exacerbation of COPD will be recorded.
Up to week 52 of the follow-up phase.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical symptom assessment questionnaire
Time Frame: Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Clinical symptom assessment questionnaire of COPD will be used to assess symptoms.
Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
CAT
Time Frame: Change from baseline CAT scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
COPD assessment test (CAT) will be used to assess quality of life.
Change from baseline CAT scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Arterial partial pressure of oxygen (PaO2)
Time Frame: Change from baseline PaO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
PaO2 will be evaluated by arterial blood gas analysis.
Change from baseline PaO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Arterial partial pressure of carbon dioxide (PaCO2)
Time Frame: Change from baseline PaCO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
PaCO2 will be evaluated by arterial blood gas analysis.
Change from baseline PaCO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
FEV1
Time Frame: Change from baseline FEV1 at week 52 of the treatment phase, and week 52 of the follow-up phase.
Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.
Change from baseline FEV1 at week 52 of the treatment phase, and week 52 of the follow-up phase.
Duration of mechanical ventilation
Time Frame: Change from baseline duration of mechanical ventilation at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
The duration of mechanical ventilation will be recorded.
Change from baseline duration of mechanical ventilation at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Health economics
Time Frame: Up to week 52 of the follow-up phase.
Cost of the treatment phase and follow-up phase will be recorded
Up to week 52 of the follow-up phase.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Investigators

  • Study Chair: Suyun Li, Doctor, The First Affiliated Hospital of Henan University of Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2019

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

January 7, 2020

Last Update Submitted That Met QC Criteria

January 5, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCM for COPD with CRF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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