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

Phase 3

• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Respiratory Failure
• Interventions: Drug: Placebo Yiqi Huoxue Huatan granule; Drug: Yiqi Huoxue Huatan granule

• Registration Number: NCT04208581
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2019-10-08
• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-20
• Study First Posted: 2019-12-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-05
• Last Update Posted: 2020-01-07
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 372

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Yiqi Huoxue Huatan granule plus Western medicine	Placebo Yiqi Huoxue Huatan granule	Patients in this arm will receive placebo Yiqi Huoxue Huatan granule in addition to Western medicine.
Yiqi Huoxue Huatan granule plus Western medicine	Yiqi Huoxue Huatan granule	Patients in this arm will receive Yiqi Huoxue Huatan granule in addition to Western medicine.

Primary Outcome Measures

Name	Time	Method
All-cause mortality	Up to week 52 of the follow-up phase.	All-cause mortality will be calculated in this study.
Frequency of acute exacerbation of COPD	Up to week 52 of the follow-up phase.	Frequency of acute exacerbation of COPD will be recorded.

Secondary Outcome Measures

Name	Time	Method
Arterial partial pressure of oxygen (PaO2)	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.
Clinical symptom assessment questionnaire	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.
FEV1	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.
Duration of mechanical ventilation	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.
Health economics	Up to week 52 of the follow-up phase.	Cost of the treatment phase and follow-up phase will be recorded
Arterial partial pressure of carbon dioxide (PaCO2)	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.
CAT	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.

Trial Locations

Locations (1)

Beijing Changping TCM Hospital; 🇨🇳 Beijing, China