Clinical trial NCT03745261: Effect of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD
Official title: A Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Effectiveness of Yong Chong Cao Capsule on Outcomes in Patients With Mild to Severe COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
mild, moderate, severe
Medicine, Chinese Traditional
Cordyceps sinensis
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Jiangsu Famous Medical Technology Co., Ltd.
First posted: 2018-11-19
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of Yong Chong Cao capsule on outcomes in patients with mild to severe Chronic Obstructive Pulmonary Disease (COPD).

Detailed description: The aim of this study is to compare the effectiveness of two treatments for mild to severe COPD patients: one, Yong Chong Cao capsule treatment and conventional medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines; the other, Bailing capsule treatment and conventional medicine.

COPD, with high prevalence, morbidity, mortality and economic burdens, affects millions worldwide. Although many therapies exist and are being developed to relieve symptoms and reduce mortality in COPD, most have only been studied in placebo-controlled efficacy studies in highly selected populations. There are few clinical trials to compare therapeutic alternatives in real world. Furthermore, some randomized controlled trials on Yong Chong Cao capsule, one therapeutic type of Cordyceps sinensis in traditional Chinese medicine (TCM) interventions, especially based on the syndrome of insufficiency of qi of the lung and kidney patterns, have been the certain evidence for showing definite effect for COPD patients. In addition, studies in real world populations of COPD that received different cordyceps sinensis therapies that do have efficacy evidence was found wide variations in care delivery. In short, there is a need to compare the effectiveness of two capsule in patients with mild to severe COPD.

This is a multi-center, open-label, randomized, controlled study to evaluate the effectiveness of Yong Chong Cao capsule for patients with mild to severe COPD compared with Bailing capsule. Following a 14 day run-in period, approximately 240 subjects will be randomly assigned to Yong Chong Cao capsule treatment group, Bailing capsule treatment group for 24 weeks. After the 24 weeks treatment period, subjects in two treatments arms will follow-up 24 weeks. The primary outcome measure is the frequency of exacerbations. The secondary efficacy measures include FEV1, dyspnea (MMRC), exercise capacity(6MWD), quality of life (CAT, SGRQ). Safety will be assessed through the collection of adverse events. There will be a total of 4 study visits (baseline, the 12 and 24 weeks of the treatment, the 24 weeks of follow-up).

Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of mild to severe COPD.
* Medically stable.
* Syndrome differentiation belongs to syndrome of insufficiency of qi of the lung and kidney.
* Age between 18 and 80 years.
* With the informed consent signed.

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis, lung cancer).
* Complicated with heart failure (NYHA Class III or IV), or myocardial infarction within six months ,or unstable hemodynamics.
* Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
* Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
* Participating in other trials or allergic to the used medicine.
* Participating in other clinical trials with other interventions in one month.
* Allergic to the used medicine.

Primary outcomes:
measure: The frequency of exacerbation of COPD
timeFrame: Changes in the frequency of exacerbation at the week 12 and week 24 of the treatment phase, and at the week 24 of the follow-up phase compared with baseline.
Secondary outcomes:
measure: Changes in Modified Medical Research Council scale scores
timeFrame: Changes in the mMRC scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
measure: Changes in Forced expiratory volume in one second
timeFrame: Changes in FEV1 at the week 24 of the treatment phase and the week 24 of the follow-up phase compared with baseline.
measure: Changes in COPD Assessment Test scores
timeFrame: Changes in the CAT scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
measure: Changes in Six Minutes Walking Distance
timeFrame: Changes in the 6WMD scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
measure: Changes in St Georges respiratory questionnaire scores
timeFrame: Changes in the SGRQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
measure: Changes in clinical COPD questionnaire scores
timeFrame: Changes in the CCQ scores at the week 12 and week 24 of the treatment phase, and the week 24 of the follow-up phase compared with baseline.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of HUCM
name: Suyun Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: