Efficacy and Safety of Lifei Qingchang Granules for Stable Bronchiectasis

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Bronchiectasis

In brief

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.

Key facts

Study ID

NCT07523165

Run by

The First Affiliated Hospital of Guangzhou Medical University

People needed

150

Starts

2026-04-01

Expected to finish

2028-04-01

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China

Full record on ClinicalTrials.gov

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