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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

372 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-08

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Obstructive Pulmonary Disease Chronic Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Yiqi Huoxue Huatan granule plus Western medicine

Patients in this arm will receive Yiqi Huoxue Huatan granule in addition to Western medicine.

Group Type EXPERIMENTAL

Yiqi Huoxue Huatan granule

Intervention Type DRUG

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 granule plus Western medicine

Patients in this arm will receive placebo Yiqi Huoxue Huatan granule in addition to Western medicine.

Group Type PLACEBO_COMPARATOR

Placebo Yiqi Huoxue Huatan granule

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Tiotropium Bromide Powder for Inhalation Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation Tiotropium Bromide Powder for Inhalation Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No