Bronchiectasis
Conditions
Interventions
High-Dose Group:High dose Twice daily (BID) via nebulization
Low-Dose Group:Low dose Twice daily (BID) via nebulization
Placebo Group:Placebo Twice daily (BID) via nebulization
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years old (inclusive of both 18 and 75 years of age), regardless of gender; 2.Outpatients clinically diagnosed with bronchiectasis, presenting with chronic cough and expectoration symptoms (with symptoms such as chronic cough and expectoration, and having evidence of chest plain or thin-section CT from the study center either at screening or within 12 months prior to screening); 3.In a stable phase of bronchiectasis prior to randomization (no significant changes in daytime and nighttime respiratory symptoms compared to their usual state for 4 consecutive weeks, and no acute exacerbation of bronchiectasis or acute upper respiratory tract infection within 4 consecutive weeks); 4.At least 1 acute exacerbation of bronchiectasis within 2 years prior to screening; 5.Isolation of the opportunistic pathogen Pseudomonas aeruginosa (PA) during screening, and susceptibility testing during screening indicates that the patient’s PA is not resistant to HK241; 6.Forced Expiratory Volume in 1 second (FEV1) >= 30% of the predicted value; 7.Able to correctly use the nebulizer for treatment after instruction and accurately complete the diary card; 8.Females of childbearing potential and sexually active males whose partners are of childbearing potential must agree to use at least one highly effective contraceptive method, or two approved barrier contraceptive methods, or abstain from sexual intercourse throughout the study period and for 30 days after the end of treatment; 9.Fully understand the purpose and requirements of the study, voluntarily participate in the clinical study, sign a written informed consent form, and be able to complete the entire study process as required by the protocol.
Exclusion criteria
Exclusion criteria: 1.Patients with bronchiectasis caused by cystic fibrosis or a1-antitrypsin deficiency, as determined by investigators based on medical history and other relevant information; 2.Patients complicated with asthma, allergic bronchopulmonary aspergillosis (ABPA), active pulmonary tuberculosis, or active nontuberculous mycobacterial (NTM) infection requiring standardized treatment; 3.Patients complicated with respiratory or gastrointestinal diseases that are inappropriate for nebulized inhalation therapy or may affect its efficacy, such as severe oral ulcers, pharyngeal ulcers, pulmonary edema, active gastric ulcers, or moderate-to-severe gastroesophageal reflux disease (GERD); 4.Patients with known allergy or intolerance to quinolone or fluoroquinolone drugs (e.g., joint or tendon disorders); 5.Patients with moderate or massive hemoptysis secondary to bronchiectasis within the past 6 months (moderate hemoptysis: hemoptysis volume of 100-500ml within 24 hours; massive hemoptysis: hemoptysis volume exceeding 500ml within 24 hours or more than 100ml in a single episode); 6.Patients with a history of severe cardiovascular diseases (e.g., congestive heart failure, clinically significant coronary artery disease, stroke, myocardial infarction and/or stroke occurring within the past 6 months, clinically significant arrhythmia, prolonged QTc interval [QTc > 450ms], known aortic aneurysm and dissection, cardiac valve regurgitation, uncontrolled hypertension [systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg in two or more consecutive measurements]); 7.Uncorrected hypokalemia or hypomagnesemia prior to drug administration; 8.Patients with uncontrolled diabetes mellitus or fasting blood glucose > 10 mmol/L; 9.Patients with myasthenia gravis, Parkinson's disease, or a history of epileptic seizures; 10.Patients with severe mental illness, hematological diseases, or malignant tumors; 11.Patients with significant abnormalities of liver or kidney function (ALT and/or AST > 2 times the upper limit of normal [ULN]; serum creatinine [Cr] > 1.5 times the ULN); subjects with stable chronic hepatitis B or C are acceptable if ALT < 1.5 times the ULN at screening and meet other inclusion criteria; however, subjects coinfected with hepatitis B and C are not eligible; 12.Patients who received inhaled, oral, or intravenous antibiotics within 30 days prior to screening; 13.Patients requiring oral or intravenous corticosteroid therapy, or who used systemic corticosteroids within 30 days prior to screening; 14.Patients requiring oral or intravenous anticholinergic therapy, or who used systemic anticholinergic drugs within 30 days prior to screening; 15.Patients with chronic respiratory failure requiring long-term non-invasive mechanical ventilation or oxygen therapy (more than 10 hours per day); 16.Subjects of childbearing potential who have plans to conceive, freeze or donate sperm/eggs from screening until 3 months after the last dose, or who refuse to use effective contraceptive methods (complete abstinence, barrier methods, oral contraceptives, intrauterine devices [IUDs], or sterilization surgery); 17.Patients whose last treatment with an investigational product (drug or medical device) in a previous clinical trial was <= 4 weeks prior to screening (or <= 16 weeks or 5 half-lives for therapeutic biological products, whichever is longer), or who have not withdrawn from other interventional clinical trials before enrollment; 18.Patients for whom i
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Pseudomonas aeruginosa (PA) Burden in Sputum Culture from Baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life-Bronchiectasis Respiratory Symptom Scale (QOL-B-RSS) Score ;Change in Bronchiectasis Health Questionnaire (BHQ) Score from Baseline;Change in Sputum Volume Within 24 Hours Prior to the Visit from Baseline;Change in Sputum Purulence Score from Baseline;Change in Forced Expiratory Volume in 1 Second as a Percentage of Predicted Value (FEV1%pred) from Baseline;Change in Minimum Inhibitory Concentration (MIC) of Pseudomonas aeruginosa (PA) from Baseline;Safety Endpoints: Adverse Events (AEs), Serious Adverse Events (SAEs), Laboratory Tests, Vital Signs, and Other Relevant Indicators; | — |
Countries
China
Contacts
Public ContactWeijie Guan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed