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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04208581
• Other study ID #: TCM for COPD with CRF
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: October 8, 2019
• Est. completion date: December 2021

Study information

• Verified date: January 2020
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 372
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Chronic Respiratory Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Beijing Changping TCM Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	The Affiliated Hospital of Liaoning University of TCM

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality will be calculated in this study.	Up to week 52 of the follow-up phase.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Health economics	Cost of the treatment phase and follow-up phase will be recorded	Up to week 52 of the follow-up phase.