Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis (NCT06093191) | Clinical Trial Compass
CompletedPhase 4
Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis
China371 participantsStarted 2023-10-18
Plain-language summary
People with bronchiectasis are prone to Pseudomonas aeruginosa (PA) infections, which can become chronic and lead to increased death rates and disease severity. Studies from cystic fibrosis suggest that eradication therapy aimed at PA can successfully transition patients to a culture-negative status, providing long-term benefits. Current guidelines for managing bronchiectasis in adults recommend eradicating PA when it is first or newly isolated; however, there is a lack of randomized controlled trials supporting such recommendations. The researchers hypothesize that both oral ciprofloxacin combined with tobramycin inhalation solution and tobramycin inhalation solution alone are superior to no eradication (inhaled saline) in terms of the eradication rate of PA (with eradication defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more after the first drug administration).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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
Exclusion criteria
✕. Patients who are allergic to or cannot tolerate the investigational drugs (Tobramycin, Ciprofloxacin)
What they're measuring
1
The proportion of subjects with sustained negative sputum cultures for Pseudomonas aeruginosa (defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more) after first drug administration.
✕. 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 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.
✕. 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 hearing loss or those who are determined by the researcher to have clinically significant chronic tinnitus
✕. Participants with a history of prolonged QT intervals or those whose electrocardiograms show prolonged QT intervals during the screening period