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

Study Overview
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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.

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.

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

Conditions
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Chronic Obstructive Pulmonary Disease, Chronic Respiratory Failure

Intervention / Treatment
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* Drug: Yiqi Huoxue Huatan granule
* Drug: Placebo Yiqi Huoxue Huatan granule


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yiqi Huoxue Huatan granule plus Western medicine<br>Patients in this arm will receive Yiqi Huoxue Huatan granule in addition to Western medicine. | Drug: Yiqi Huoxue Huatan granule<br>* 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.<br>* Other names: Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation;|
| Placebo Comparator: Placebo Yiqi Huoxue Huatan granule plus Western medicine<br>Patients in this arm will receive placebo Yiqi Huoxue Huatan granule in addition to Western medicine. | Drug: Placebo Yiqi Huoxue Huatan granule<br>* 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.<br>* Other names: Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Obstructive Pulmonary Disease, Chronic Respiratory Failure, Yiqi Huoxue Huatan Granule