Bronchiectasis
Conditions
Interventions
Tobramycin Inhalation Solution group :Tobramycin Inhalation Solution, 300 mg twice daily (BID) via nebulization for 12 weeks.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 years and 80 years at screening 2. Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator-confirmed diagnosis of bronchiectasis by CT scan 3. During the screening period, patients must remain clinically stable (no significant changes in respiratory symptoms and no upper respiratory tract infection or bronchiectasis exacerbations for 4 weeks) 4. During the screening period, patients must have a positive P. aeruginosa culture in their respiratory specimens and must meet one of the following criteria: (1) they have never been isolated with P. aeruginosa from sputum or bronchoalveolar lavage fluid (BALF) before; (2) they were isolated with P. aeruginosa from sputum or BALF for the first time within 12 months before screening; (3) they had prior isolation of P. aeruginosa but not within the last 24 months (defined as having negative sputum or bronchoalveolar lavage fluid culture results at least twice before starting antibiotic treatment) 5. During the screening period, P. aeruginosa is not resistant to Tobramycin based on the drug sensitivity test of sputum culture in vitro; 6. Patient can tolerate nebulized inhalation therapy 7. Signed and dated written informed consent prior to admission to the study in accordance with local legislation.
Exclusion criteria
Exclusion criteria: 1. Patients who are allergic to or cannot tolerate Tobramycin. 2. Patients with uncontrolled asthma, physician-diagnosed cystic fibrosis, and current diagnosis of allergic bronchopulmonary aspergillosis, hypogammaglobulinemia, common variable immunodeficiency, mycobacterial infection (including pulmonary non-tuberculous mycobacterial disease) requiring treatment. 3. 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 4. 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. 5. Clinically significant lab abnormalities at screening: (1) AST and/or ALT >2 ULN at screening period (2) Serum creatinine >1.5 ULN at screening period 6. Participants with a history of prolonged QT intervals or those whose electrocardiograms show prolonged QT intervals during the screening period 7. Participants with a history of hearing loss or those who are determined by the researcher to have clinically significant chronic tinnitus 8. Participants who have used drugs that are prohibited according to the plan during the screening period. 9. Women of childbearing potential adhering to contraception requirements. 10. Participants who have participated in other clinical trials (defined as those where medication has been administered) within the 4 weeks prior to the screening 11. 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. 12. Patients with FEV1% of predicted value<30% 13. Participants who are deemed unsuitable for inclusion in the study due to other reasons, as determined by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 12 weeks post-dose initiation, during a designated dosing interval, tobramycin concentrations in ELF and serum as well as its penetration ratio from ELF to blood;Change in Pseudomonas aeruginosa (PA) bacterial load in ELF cultures from baseline at 12 weeks post-treatment initiation;Culture Negativity Conversion Rate of Pseudomonas aeruginosa (PA) in ELF at 12 Weeks Post-Treatment Initiation;Pharmacokinetic (PK) Characteristics in ELF and Serum at 12 Weeks Post-Treatment Initiation;Minimum Inhibitory Concentration (MIC) of Tobramycin against Pseudomonas aeruginosa (PA) at Baseline and 12 Weeks Post-Treatment Initiation;Correlation Analysis between CELF/MIC at Each Time Point and Microbiological Response;Correlation Analysis between AUC0-t/MIC in ELF and Microbiological Response (Calculated from mean ELF concentrations at each time point); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Quality of Life-Bronchiectasis Respiratory Symptom Scale (QOL-B-RSS) Score at 12 Weeks Post-Treatment Initiation;Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs); | — |
Countries
China
Contacts
Public ContactWeijie Guan
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed