NCT07523165

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
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.
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.
PROCEDURE	Postural Drainage	Standardized postural drainage therapy to assist in sputum clearance.

Timeline

• Start date: 2026-04-01
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2026-04-13
• Last updated: 2026-04-13

Locations

3 sites across 1 country: China