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

Peking University

Status and phase

Unknown

Phase 3

Conditions

Chronic Respiratory Failure

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Yiqi Huoxue Huatan granule

Drug: Placebo Yiqi Huoxue Huatan granule

Study type

Interventional

Funder types

Other

Identifiers

NCT04208581

TCM for COPD with CRF

Details and patient eligibility

About

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.

Full 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.

Enrollment

372 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.