Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis

Phase 4

Recruiting

• Conditions: Bronchiectasis Adult; Pseudomonas Aeruginosa Infection

• Registration Number: NCT06093191
• Lead Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-10
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Male or female, aged 18 years and 80 years at screening<br><br> 2. Signed and dated written informed consent prior to admission to the study in<br> accordance with local legislation.<br><br> 3. Clinical history consistent with bronchiectasis (cough, chronic sputum production<br> and/or recurrent respiratory infections) and investigator-confirmed diagnosis of<br> bronchiectasis by CT scan<br><br> 4. During the screening period, patients must have a positive P. aeruginosa culture in<br> their sputum and must meet one of the following criteria: (1) they have never been<br> isolated with P. aeruginosa from sputum or bronchoalveolar lavage fluid (BALF)<br> before; (2) they were isolated with P. aeruginosa from sputum or BALF for the first<br> time within 12 months before screening; (3) they had prior isolation of P.<br> aeruginosa but not within the last 24 months (defined as having negative sputum<br> culture results at least twice before starting antibiotic treatment)<br><br> 5. During the screening period, patients must remain clinically stable (no significant<br> changes in respiratory symptoms and no upper respiratory tract infection or<br> bronchiectasis exacerbations for 4 weeks)<br><br> 6. During the screening period, P. aeruginosa is not resistant to Tobramycin and<br> Ciprofloxacin based on the drug sensitivity test of sputum culture in vitro<br><br> 7. Patient can tolerate nebulized inhalation therapy<br><br>Exclusion criteria<br><br> 1. Patients who are allergic to or cannot tolerate the investigational drugs<br> (Tobramycin, Ciprofloxacin)<br><br> 2. Patients with uncontrolled asthma, physician-diagnosed cystic fibrosis, and Current<br> diagnosis of allergic bronchopulmonary aspergillosis, hypogammaglobulinemia, common<br> variable immunodeficiency, mycobacterial infection (including pulmonary<br> non-tuberculous mycobacterial disease) requiring treatment.<br><br> 3. Participants with unstable cardiovascular and cerebrovascular diseases, defined as<br> those who have experienced clinically worsening symptoms (such as unstable angina,<br> rapid atrial fibrillation, cerebral hemorrhage, acute cerebral infarction, etc.) or<br> have been hospitalized due to these diseases within 90 days prior to the screening<br><br> 4. Participants with progressive or uncontrolled systemic diseases, such as those<br> affecting the urinary, hematological, digestive, endocrine, respiratory,<br> circulatory, nervous, or mental systems, are not suitable for this clinical trial.<br> This is particularly the case if these conditions are evaluated by the researcher as<br> being unstable or potentially escalating into severe conditions during the trial.<br><br> 5. AST and/or ALT >2 ULN at screening period<br><br> 6. Serum creatinine >ULN at screening period<br><br> 7. Participants with a history of hearing loss or those who are determined by the<br> researcher to have clinically significant chronic tinnitus<br><br> 8. Participants with a history of prolonged QT intervals or those whose<br> electrocardiograms show prolonged QT intervals during the screening period<br><br> 9. Participants who have used drugs that are prohibited according to the plan during<br> the screening period.<br><br> 10. Women of childbearing potential adhering to contraception requirements.<br><br> 11. Patients with FEV1% of predicted value<30%<br><br> 12. Participants who have participated in other clinical trials (defined as those where<br> medication has been administered) within the 4 weeks prior to the screening<br><br> 13. Participants who have experienced moderate or severe hemoptysis (defined as<br> expectorating 100-500ml of blood in 24 hours for moderate hemoptysis; and<br> expectorating more than 500ml in 24 hours, or a single instance of expectorating<br> more than 100ml of blood for severe hemoptysis) due to bronchiectasis within the<br> past 6 months.<br><br> 14. Participants who are deemed unsuitable for inclusion in the study due to other<br> reasons, as determined by the researcher.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients successfully eradicating PA in each group by the end of the study, defined as a negative sputum culture of PA at both 24 weeks and 36 weeks.