Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage COPD

NCT03976700 | Unknown Phase 3 DMC

• 1 other identifier: TCM for Early-Stage COPD
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Bufei Jianpi Granule; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• FEV1

  Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.

  Change from baseline FEV1 at week 26, 52, 78 and 104.

• Frequency of acute exacerbation

  Frequency of acute exacerbation will be recorded.

  Up to week 104.

Secondary Outcomes (8)

• Clinical symptom assessment questionnaire

  Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

• mMRC

  Change from baseline mMRC scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

• 6MWD

  Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.

• CAT

  Change from baseline CAT scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

• SF-36

  Change from baseline SF-36 scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

Study Arms (2)

Bufei Jianpi granule

EXPERIMENTAL

Patients in this arm will receive Bufei Jianpi granule.

Drug: Bufei Jianpi granule

Placebo Bufei Jianpi granule

PLACEBO COMPARATOR

Patients in this arm will receive placebo Bufei Jianpi granule.

Drug: Placebo Bufei Jianpi granule

Interventions

Bufei Jianpi granule DRUG

Bufei Jianpi granule is composed of many kinds of traditional Chinese medicine. The granule will be administered twice daily for five days a week for 104 weeks.

Bufei Jianpi granule

Placebo Bufei Jianpi granule DRUG

Placebo Bufei Jianpi granule consists of dextrin, bitter and 5% of the Bufei Jianpi granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group. The placebo granule will be administered twice daily for five days a week for 104 weeks.

Placebo Bufei Jianpi granule

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• Jiangsu Province Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Jiansheng Li, Professor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Suyun Li, Professor

CONTACT

86-371-66248624; lisuyun2000@126.com

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: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 6, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 6, 2019

Record last verified: 2019-05

Locations

CN (1)