Clinical trial NCT04208581: Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure
Official title: Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure: A Randomized, Double-blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Chronic Respiratory Failure
Keywords: Chronic Obstructive Pulmonary Disease
Chronic Respiratory Failure
Yiqi Huoxue Huatan Granule
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
First posted: 2019-12-23
Enrollment: 372
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause mortality
timeFrame: Up to week 52 of the follow-up phase.
measure: Frequency of acute exacerbation of COPD
timeFrame: Up to week 52 of the follow-up phase.
Secondary outcomes:
measure: Clinical symptom assessment questionnaire
timeFrame: 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.
measure: CAT
timeFrame: 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.
measure: Arterial partial pressure of oxygen (PaO2)
timeFrame: 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.
measure: Arterial partial pressure of carbon dioxide (PaCO2)
timeFrame: 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.
measure: FEV1
timeFrame: Change from baseline FEV1 at week 52 of the treatment phase, and week 52 of the follow-up phase.
measure: Duration of mechanical ventilation
timeFrame: 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.
measure: Health economics
timeFrame: Up to week 52 of the follow-up phase.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Changping TCM Hospital
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Chinese Medicine
name: Suyun Li, Doctor
role: STUDY_CHAIR
References: