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

Phase 3UnknownNCT04208581

Peking University People's Hospital372 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

372

Conditions

Chronic Obstructive Pulmonary Disease Chronic Respiratory Failure

Interventions

Yiqi Huoxue Huatan granuleDRUG

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.

Placebo Yiqi Huoxue Huatan granuleDRUG

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.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Changping TCM Hospital

Beijing, China

Outcomes

Primary Outcomes

All-cause mortality

All-cause mortality will be calculated in this study.

Time frame: Up to week 52 of the follow-up phase.

Frequency of acute exacerbation of COPD

Frequency of acute exacerbation of COPD will be recorded.

Time frame: Up to week 52 of the follow-up phase.

Secondary Outcomes

Clinical symptom assessment questionnaire

Clinical symptom assessment questionnaire of COPD will be used to assess symptoms.

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.

CAT

COPD assessment test (CAT) will be used to assess quality of life.

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.

Arterial partial pressure of oxygen (PaO2)

PaO2 will be evaluated by arterial blood gas analysis.

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.

Arterial partial pressure of carbon dioxide (PaCO2)

PaCO2 will be evaluated by arterial blood gas analysis.

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.

FEV1

Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.

Data from ClinicalTrials.gov

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