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

NCT04208581 | Unknown Phase 3 DMC

• 1 other identifier: TCM for COPD with CRF
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Respiratory Failure

Keywords

Chronic Obstructive Pulmonary Disease; Chronic Respiratory Failure; Yiqi Huoxue Huatan Granule

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Clinical symptom assessment questionnaire

  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

  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)

  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)

  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

  Change from baseline FEV1 at week 52 of the treatment phase, and week 52 of the follow-up phase.

Study Arms (2)

Yiqi Huoxue Huatan granule plus Western medicine

EXPERIMENTAL

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

Drug: Yiqi Huoxue Huatan granule

Placebo Yiqi Huoxue Huatan granule plus Western medicine

PLACEBO COMPARATOR

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

Drug: Placebo Yiqi Huoxue Huatan granule

Interventions

Yiqi Huoxue Huatan granule 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.

Also known as: Tiotropium Bromide Powder for Inhalation, Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation

Yiqi Huoxue Huatan granule plus Western medicine

Placebo Yiqi Huoxue Huatan granule 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.

Also known as: Tiotropium Bromide Powder for Inhalation, Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation

Placebo Yiqi Huoxue Huatan granule plus Western medicine

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Affiliated Hospital of Liaoning University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Beijing Changping TCM Hospital

Beijing, China

Location

Related Publications (1)

• Yang JY, Wang HT, Zhao KM, Yu XQ, Huang DH, Wang HX, Wei GS, Bai L, Hou YJ, Huang QT, Hu J, Zhu HZ, Wu L, Lu XC, Chen YF, Gao F, Su LH, Wang Y, Li CY, Li SY, Feng CL. The efficacy and safety of Yiqi Huoxue Huatan granule in the treatment of stable COPD with chronic respiratory failure: A randomized, double-blind, placebo controlled trial. J Ethnopharmacol. 2025 Aug 29;352:120228. doi: 10.1016/j.jep.2025.120228. Epub 2025 Jul 1.

  PMID: 40609812 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation; Salmeterol Xinafoate; Budesonide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Suyun Li, Doctor

  The First Affiliated Hospital of Henan University of Chinese Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 23, 2019
• Study Start: October 8, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

CN (1)