Efficacy and Safety of Lifei Qingchang Granules for Stable Bronchiectasis

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study on the Efficacy and Safety of Lifei Qingchang Granules for Stable Bronchiectasis

The purpose of this study is to evaluate the efficacy and safety of Lifei Qingchang Granules in the treatment of patients with stable bronchiectasis. This is a multicenter, randomized, double-blind, placebo-controlled clinical trial.

Researchers plan to enroll a total of 150 adult participants (aged 18-75) who have been diagnosed with stable bronchiectasis and experience at least one acute exacerbation in the past 12 months. Participants will be randomly assigned into two groups in a 1:1 ratio:

• The treatment group will receive Lifei Qingchang Granules along with standard postural drainage therapy.
• The control group will receive a matching placebo along with standard postural drainage therapy.

The treatment period will last for 3 months. The main goal is to see if the treatment can improve patients' respiratory symptoms and overall quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchiectasis
• Intervention / Treatment: Drug: Lifei Qingchang Granules; Procedure: Postural Drainage; Other: Placebo

Detailed Description

Bronchiectasis is characterized by pathological dilation of the bronchi, with main symptoms including chronic cough and expectoration. Currently, there is no specific cure, making it an urgent clinical problem. In Traditional Chinese Medicine (TCM), the pathogenesis of bronchiectasis is closely related to "phlegm-heat obstructing the lungs".

Lifei Qingchang Granule is an in-hospital preparation patented by the First Affiliated Hospital of Guangzhou Medical University (Patent No.: ZL202110246137.5, Guangdong Medical Preparation No. Z20240007001). Previous clinical observations suggest it effectively reduces acute exacerbations, decreases hemoptysis, and lowers hospitalization rates. This study aims to conduct a pre-clinical study for the transformation of this in-hospital preparation into a new drug.

This prospective, multicenter study plans to enroll 150 participants. Eligible participants must meet the diagnostic criteria for stable bronchiectasis, exhibit the TCM syndrome of "phlegm-heat obstructing the lungs," and have a history of at least one acute exacerbation in the previous 12 months.

Participants will be stratified based on their previous 12-month exacerbation frequency (<3 and ≥3 times) and randomized via an Interactive Web Response System (IWRS) into the herbal treatment group or the placebo group. Both groups will receive standardized postural drainage.

The primary efficacy endpoint is the change from baseline in the respiratory dimension score of the Quality of Life-Bronchiectasis questionnaire at month 3. Secondary endpoints include the St. George's Respiratory Questionnaire (SGRQ) score, 24-hour sputum volume, sputum characteristics (color and consistency), sputum bacteriology, TCM symptom scores, and pulmonary function tests (FVC, FEV1) at month 3. Safety assessments, including vital signs, laboratory tests, and adverse event monitoring, will be conducted throughout the study.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhimin Zhang, MD; Phone Number: 86-18928868345; Email: zhangzhimin51666@163.com
• Study Contact Backup: Name: Ran Lin, MD; Phone Number: 86-18813751030; Email: r2013051152@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510260
      • The second Affiliated Hospital of Guangzhou Medical University
      • Contact: Peng Pang, MD; Phone Number: 86-15099960366; Email: pangpeng@gzhmu.edu.cn
    • Guangzhou, Guangdong, China, 510150
      • The Third Affiliated Hospital of Guangzhou Medical University
      • Contact: Liping Wei, MD; Phone Number: 86-13650858667; Email: weilp8@hotmail.com
    • Guangzhou, Guangdong, China, 510170
      • The First Affiliated Hospital of Guangzhou Medical University
      • Contact: Zhimin Zhang, MD; Phone Number: 86-18928868345; Email: zhangzhimin51666@163.com
      • Contact: Ran Lin, MD; Phone Number: 86-18813751030; Email: r2013051152@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 to 75 years old, regardless of sex.
• Diagnosed with bronchiectasis confirmed by High-Resolution Computed Tomography (HRCT) scan.
• Bronchiectasis is currently in the stable phase.
• Experienced at least one acute exacerbation of bronchiectasis within the previous 12 months.
• Diagnosed with the Traditional Chinese Medicine (TCM) syndrome of "Phlegm-Heat Obstructing the Lungs".
• Able to understand the study protocol and voluntarily sign the informed consent form.

Exclusion Criteria:

• Allergic to any ingredients of the investigational drug or placebo.
• Comorbid with other severe systemic diseases (e.g., coronary heart disease, stroke, severe hypertension [systolic BP ≥ 180 mmHg or diastolic BP ≥ 110 mmHg], active gastric ulcer, uncontrolled diabetes [fasting venous blood glucose ≥ 10 mmol/L], malignant tumors, abnormal liver or kidney function [AST, ALT, or GGT > 2 times the upper limit of normal; or serum creatinine > 2 times the upper limit of normal]) or psychiatric disorders.
• Comorbid with asthma, allergic bronchopulmonary aspergillosis (ABPA), or active pulmonary tuberculosis.
• Comorbid with chronic obstructive pulmonary disease (COPD) and presenting COPD as the primary clinical manifestation (as judged by the investigator).
• Use of inhaled, oral, or intravenous antibiotics within 4 weeks prior to enrollment.
• Type 2 respiratory failure requiring long-term non-invasive mechanical ventilation or oxygen therapy (> 10 hours/day).
• History of drug abuse, psychotropic drug dependence, or alcohol abuse.
• Current smokers or those unable to stop smoking during the study.
• Pregnant or lactating women, planning to become pregnant during the study, or refusing to use reliable contraceptive methods throughout the study period.
• Participation in any other clinical trials within 3 months prior to enrollment.
• Considered unsuitable for participation in this clinical study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental: Lifei Qingchang Granules; Participants in this arm will receive Lifei Qingchang Granules combined with postural drainage. The granules are administered orally, 1 sachet each time, 3 times a day , for a total duration of 3 months.	Drug: Lifei Qingchang Granules; A Traditional Chinese Medicine in-hospital preparation (Patent No.: ZL202110246137.5). Administered orally, 1 sachet per dose, 3 doses per day for 3 months.; Procedure: Postural Drainage; Standardized postural drainage therapy to assist in sputum clearance.
Placebo Comparator: Placebo Comparator: Placebo; Participants in this arm will receive a matching placebo combined with postural drainage. The placebo is administered orally, 1 sachet each time, 3 times a day , for a total duration of 3 months.	Procedure: Postural Drainage; Standardized postural drainage therapy to assist in sputum clearance.; Other: Placebo; An inactive matching placebo primarily composed of dextrin, lactose, edible essence, and food coloring. Administered orally, 1 sachet per dose, 3 doses per day for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Respiratory Domain Score of the Quality of Life-Bronchiectasis (QOL-B) Questionnaire	The QOL-B questionnaire is utilized to assess the impact of bronchiectasis on daily life, specifically focusing on the respiratory domain which evaluates symptoms such as cough, sputum production, and shortness of breath.	Baseline and Month 3 (Day 84)

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Score	Baseline and Month 3 (Day 84)
Change from Baseline in 24-hour Sputum Volume	Baseline and Month 3 (Day 84)
Change from Baseline in Pulmonary Function (FVC and FEV1)	Baseline and Month 3 (Day 84)
Change from Baseline in Sputum Characteristics (Color and Consistency) Score	Baseline and Month 3 (Day 84)
Change from Baseline in Traditional Chinese Medicine (TCM) Syndrome Score	Baseline and Month 3 (Day 84)

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Collaborators: The Third Affiliated Hospital of Guangzhou Medical University; Second Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

General Publications

• Zhang ZM, Ren PH, Wu ZJ, Zhang DP, Xie WJ. Personalized alternative therapy of intractable bronchiectasis-induced hemoptysis in a patient: syndrome differentiation and treatment according to individual physique category. J Thorac Dis. 2013 Jun;5(3):E115-7. doi: 10.3978/j.issn.2072-1439.2013.06.26. No abstract available.
• Yuanlong H, Wanyan L, Jiamin Z, Shangke G, Yingsi D, Ran L, Zhu L, Shiting D, Min H, Zhiming P, Qifen H, Zhijuan W, Xinghua S, Shouxie H, Zhenqiu L, Dapeng Z, Wenju L, Zhimin Z. Lifei Qingchang Granules alleviate airway inflammation in a mouse model of bronchiectasis by inhibiting neutrophil extracellular traps. J Ethnopharmacol. 2026 Feb 10;356:120855. doi: 10.1016/j.jep.2025.120855. Epub 2025 Nov 4.
• Huang QF, Zeng JM, Hu YL, Li WY, Yu QH, Wang P, Ren PH, Peng Y, Guan WJ, Lin R, Li ZQ, Tan WL, Zhu HP, Huang SX, Zhang DP, Jie ZC, Wu ZJ, Zhang ZM. Lifei Qingchang Tang attenuates acute lung injury via the NF-kappaB and MAPK signaling pathways. J Asian Nat Prod Res. 2025 Nov;27(11):1690-1705. doi: 10.1080/10286020.2025.2473648. Epub 2025 Mar 12.
• Zhang ZM, Ren PH, Guan WJ. Symptom-based treatment with Traditional Chinese Medicine in bronchiectasis patients with hemoptysis. J Thorac Dis. 2017 Sep;9(9):E884-E886. doi: 10.21037/jtd.2017.08.170. No abstract available.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Postural Drainage; Stable Bronchiectasis; Phlegm-Heat Syndrome; Lifei Qingchang Granules
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis; Therapeutics; Physical Therapy Modalities; Rehabilitation; Respiratory Therapy; Drainage; Drainage, Postural
• Other Study ID Numbers: GMUCR2025-01009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly to strictly protect patient privacy and comply with the confidentiality agreement approved by the Ethics Committee. All electronic data are encrypted and stored on dedicated hospital servers. Only authorized parties, such as the Ethics Committee and regulatory authorities, have access to the original records under strict confidentiality protocols.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No