Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis

Who can take part

• Male or female, aged 18 years and 80 years at screening
• Signed and dated written informed consent prior to admission to the study in accordance with local legislation
• Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator-confirmed diagnosis of bronchiectasis by high-resolution CT (HRCT) scan
• Positive sputum culture for PA during screening, and meeting one of the following three conditions:; ① No prior isolation of PA from respiratory secretions (a positive sputum culture from the study hospital within 1 month before screening was accepted, provided that no antibiotics were used for ≥14 days before the culture); ② First isolated PA within 12 months prior to screening, but did not undergo eradication therapy (continuous oral/intravenous/inhaled antibiotic treatment ≥1 month, excluding macrolides); ③ Previously isolated PA, but respiratory secretions were negative for PA at least twice (separated by an interval of ≥3 months) for 24 months or more prior to screening (Requirement: respiratory secretion isolation results obtained while not using antibiotics for 14 days or more)
• During the screening period, patients must remain clinically stable (no significant changes in daytime and nighttime respiratory symptoms and no upper respiratory tract infection or bronchiectasis exacerbations for 4 weeks)
• During the screening period, P. aeruginosa is not resistant to Tobramycin and Ciprofloxacin based on the drug sensitivity test of sputum culture in vitro
• Patient can tolerate nebulized inhalation therapy

Who cannot take part

• Patients who are allergic to or cannot tolerate the investigational drugs (Tobramycin, Ciprofloxacin)
• Comorbid uncontrolled asthma (defined as ≥1 acute exacerbation within 1 week prior to screening); confirmed bronchiectasis due to cystic fibrosis; Allergic Bronchopulmonary Aspergillosis (ABPA); active pulmonary tuberculosis; or nontuberculous mycobacterial infection requiring standard anti-nontuberculous treatment
• Participants with unstable cardiovascular and cerebrovascular diseases, defined as those who have experienced clinically worsening symptoms (such as unstable angina, rapid atrial fibrillation, cerebral hemorrhage, acute cerebral infarction, etc.) or have been hospitalized due to these diseases within 90 days prior to the screening
• Participants who have used drugs that are prohibited according to the plan during the screening period
• Participants who have participated in other clinical trials (defined as those where medication has been administered) within the 4 weeks prior to the screening
• Participants with progressive or uncontrolled systemic diseases, such as those affecting the urinary, hematological, digestive, endocrine, respiratory, circulatory, nervous, or mental systems, are not suitable for this clinical trial. This is particularly the case if these conditions are evaluated by the researcher as being unstable or potentially escalating into severe conditions during the trial
• Participants with a history of hearing loss or those who are determined by the researcher to have clinically significant chronic tinnitus
• AST and/or ALT >2 ULN and/or Total Bilirubin (TBIL) at screening period
• Serum creatinine >ULN at screening period
• Participants with a history of prolonged QT intervals or those whose electrocardiograms show prolonged QT intervals during the screening period
• Women who are pregnant or lactating, or women of childbearing potential preparing for pregnancy
• Patients with FEV1% of predicted value<30%
• Participants who have experienced moderate or severe hemoptysis (defined as expectorating 100-500ml of blood in 24 hours for moderate hemoptysis; and expectorating more than 500ml in 24 hours, or a single instance of expectorating more than 100ml of blood for severe hemoptysis) due to bronchiectasis within the past 6 months
• Participants who are deemed unsuitable for inclusion in the study due to other reasons, as determined by the researcher