Clinical trial NCT03976713: Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD
Official title: Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD: A Randomized, Double-blind, Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
Bufei Yishen Granule
Randomized Controlled Trial
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: ShuGuang Hospital
First posted: 2019-06-06
Enrollment: 348
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 Bufei Yishen granule for GOLD stage 3 or 4 chronic obstructive pulmonary disease (COPD), reducing acute exacerbation, improving exercise capacity 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. Frequent acute exacerbation and exercise limitation broadly exist in COPD patients, especially those in GOLD stage 3 or 4. Although appropriate pharmacological therapies have been proven to be effective in COPD management, however, many gaps are still to be filled. For example, the adverse effects of pharmacologic therapies can never be ignored. The investigator's previous studies suggested that traditional Chinese medicine (TCM) has effect on GOLD stage 3 or 4 COPD.

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Bufei Yishen granule on reducing acute exacerbation in GOLD stage 3 or 4 COPD subjects. After a 14-day run-in period, 348 subjects will be randomly assigned to treatment group or control group for 52-week treatment. The primary outcomes are frequency and duration of acute exacerbation. The secondary outcomes include mortality, pulmonary function, clinical symptoms, exercise capacity, quality of life and treatment satisfaction. Safety will also be assessed.

Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of GOLD stage 3 or 4 COPD.
* Syndrome differentiation meets criteria of Qi deficiency of the lung and spleen syndrome, Qi deficiency of the lung and kidney syndrome or Qi and Yin deficiency of the lung and kidney syndrome.
* Age ranges from 40 years to 80 years.
* With informed consent signed.

Exclusion Criteria:

* Pregnant and lactating women.
* Patients with severe cardiovascular and cerebrovascular diseases.
* Patients with severe liver and kidney diseases.
* Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism, chronic respiratory failure or other severe respiratory diseases.
* Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
* Patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases.
* Patients with severe cognitive and psychiatric disorders.
* Patients with diabetes.
* Patients who were administered oral glucocorticoids in the past 4 weeks.
* Patients who have participated in other clinical studies in the past 4 weeks.
* People who are allergic to the treatment drugs.
* Patients who have experienced one or more acute exacerbation in the past 4 weeks.

Primary outcomes:
measure: Frequency of acute exacerbation
timeFrame: Up to week 52.
measure: Duration of acute exacerbation
timeFrame: Up to week 52.
Secondary outcomes:
measure: Mortality
timeFrame: Up to week 52.
measure: FEV1
timeFrame: Change from baseline FEV1 at week 26 and 52.
measure: Clinical symptom assessment questionnaire
timeFrame: Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52.
measure: 6MWD
timeFrame: Change from baseline 6MWD at week 13, 26, 39 and 52.
measure: CAT
timeFrame: Change from baseline CAT scores at week 13, 26, 39 and 52.
measure: SF-36
timeFrame: Change from baseline SF-36 scores at week 13, 26, 39 and 52.
measure: mCOPD-PRO
timeFrame: Change from baseline mCOPD-PRO scores at week 13, 26, 39 and 52.
measure: mESQ-COPD
timeFrame: Change from baseline mESQ-COPD scores at week 13, 26, 39 and 52.
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 Henan University of Traditional Chinese Medicine
name: Jiansheng Li, Professor
role: STUDY_CHAIR
References: