Clinical trial NCT03976700: Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage COPD
Official title: Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage 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 Jianpi Granule
Randomized Controlled Trial
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Jiangsu Province Hospital of Traditional Chinese Medicine
First posted: 2019-06-06
Enrollment: 612
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 Jianpi granule for early-stage (GOLD stage 1 or 2) chronic obstructive pulmonary disease (COPD), delaying pulmonary function decline 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. More than 70% of patients with COPD are in GOLD stage 1 (mild) or 2 (moderate), with very mild or no apparent respiratory symptoms such as dyspnea. The Tiotropium in Early Chronic Obstructive Pulmonary Disease Patients in China (Tie-COPD) trial was designed to investigate the effect of tiotropium on the FEV1 in COPD patients with GOLD stage 1 or 2. The investigator's previous studies also suggested that traditional Chinese medicine (TCM) has effect on GOLD stage 1 or 2 COPD.

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Bufei Jianpi granule for delaying pulmonary function decline in early-stage (GOLD stage 1 or 2) COPD subjects. After a 14-day run-in period, 612 subjects will be randomly assigned to treatment group or control group for 104-week treatment. The primary outcomes include pulmonary function and frequency of acute exacerbation. The secondary outcomes include clinical symptoms, dyspnea, exercise capacity, quality of life and treatment satisfaction. Safety will also be assessed.

Eligibility criteria: Inclusion Criteria:

* A confirmed diagnosis of early-stage (GOLD stage 1 or 2) COPD.
* Syndrome differentiation meets criteria of Qi deficiency of the lung syndrome, Qi deficiency of the lung and spleen syndrome or Qi 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 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.
* People who are allergic to the treatment drugs.
* Patients who have participated in other clinical studies in the past 4 weeks.
* Patients who have experienced one or more acute exacerbation in the past 4 weeks.

Primary outcomes:
measure: FEV1
timeFrame: Change from baseline FEV1 at week 26, 52, 78 and 104.
measure: Frequency of acute exacerbation
timeFrame: Up to week 104.
Secondary outcomes:
measure: Clinical symptom assessment questionnaire
timeFrame: Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: mMRC
timeFrame: Change from baseline mMRC scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: 6MWD
timeFrame: Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: CAT
timeFrame: Change from baseline CAT scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: SF-36
timeFrame: Change from baseline SF-36 scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: mCOPD-PRO
timeFrame: Change from baseline mCOPD-PRO scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: EQ-5D
timeFrame: Change from baseline EQ-5D scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
measure: mESQ-COPD
timeFrame: Change from baseline mESQ-COPD scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
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: