Efficacy and Safety of Lifei Qingchang Granules for Stable Bronchiectasis

NCT07523165 | Not Yet Recruiting Phase 2

• 1 other identifier: GMUCR2025-01009
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Bronchiectasis

Keywords

Stable Bronchiectasis; Traditional Chinese Medicine; Phlegm-Heat Syndrome; Lifei Qingchang Granules; Postural Drainage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (2)

Experimental: Lifei Qingchang Granules

EXPERIMENTAL

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; Procedure: Postural Drainage

Placebo Comparator: Placebo

PLACEBO COMPARATOR

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.

Other: Placebo; Procedure: Postural Drainage

Interventions

Lifei Qingchang Granules DRUG

A Traditional Chinese Medicine in-hospital preparation (Patent No.: ZL202110246137.5). Administered orally, 1 sachet per dose, 3 doses per day for 3 months.

Experimental: Lifei Qingchang Granules

Placebo OTHER

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.

Placebo Comparator: Placebo

Postural Drainage PROCEDURE

Standardized postural drainage therapy to assist in sputum clearance.

Experimental: Lifei Qingchang Granules; Placebo Comparator: Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Guangzhou Medical University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: lead
• Second Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (3)

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510150, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510170, China

Location

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

Related Publications (4)

• 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.

  PMID: 41192693 RESULT

• 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.

  PMID: 40072449 RESULT

• 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.

  PMID: 23825784 RESULT

• 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.

  PMID: 29221370 RESULT

MeSH Terms

Conditions

Bronchiectasis

Interventions

Drainage, Postural

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Physical Therapy Modalities; Rehabilitation; Respiratory Therapy

Central Study Contacts

Zhimin Zhang, MD

CONTACT

86-18928868345; zhangzhimin51666@163.com

Ran Lin, MD

CONTACT

86-18813751030; r2013051152@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: In addition to the roles listed above, data managers and statisticians are also strictly masked to the treatment assignments until the database is locked for final analysis. The experimental drug (Lifei Qingchang Granules) and the placebo are identical in appearance, smell, packaging, and dosage instructions. An independent statistician generates the randomization sequence, which is directly imported into the central Interactive Web Response System (IWRS). Investigators distribute the study drugs solely based on the unique medication code assigned by the IWRS, ensuring the blind is maintained throughout the process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomly assigned to either the experimental group (Lifei Qingchang Granules) or the placebo group in a 1:1 ratio. To ensure baseline balance between the two groups, the randomization is stratified based on the participants' frequency of acute exacerbations of bronchiectasis in the previous 12 months (\<3 times vs. ≥3 times). Throughout the study, participants in both arms will receive standardized postural drainage as a background therapy.

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)