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.
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.
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).
Parallel
Lifei Qingchang Granules
DrugA Traditional Chinese Medicine in-hospital preparation (Patent No.: ZL202110246137.5). Administered orally, 1 sachet per dose, 3 doses per day for 3 months.
Placebo
Other interventionAn 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.
Postural Drainage
Procedure/SurgeryStandardized postural drainage therapy to assist in sputum clearance.
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.
Change from Baseline in St. George's Respiratory Questionnaire (SGRQ) Score
Change from Baseline in 24-hour Sputum Volume
Change from Baseline in Pulmonary Function (FVC and FEV1)
Change from Baseline in Sputum Characteristics (Color and Consistency) Score
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The First Affiliated Hospital of Guangzhou Medical University
Lead sponsor
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
The Third Affiliated Hospital of Guangzhou Medical University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
