Using Tobramycin inhalation to treat Pseudomonas infections in bronchiectasis

Efficacy and Safety of tobRamycin Inhalation Solution for Pseudomonas AeruginoSa Eradication in Bronchiectasis (ERASE): a Multi-center, 2×2 Factorial Randomized, Double-blind, Placebo-controlled Trial

This study is testing if inhaling Tobramycin, with or without an oral antibiotic, can help people with bronchiectasis get rid of Pseudomonas infections.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 364 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China (Academic / other)
• Locations: 63 sites (Haikou, Hainan and 62 other locations)
• Trial ID: NCT06093191 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of Tobramycin inhalation solution, both alone and in combination with oral ciprofloxacin, for eradicating Pseudomonas aeruginosa infections in patients with bronchiectasis. The study is designed as a multicenter, double-blind, placebo-controlled trial, comparing these treatments against inhaled saline. The primary goal is to determine the eradication rates of Pseudomonas aeruginosa, measured by negative sputum cultures at 24 and 36 weeks. The trial aims to fill the gap in evidence regarding the management of Pseudomonas infections in bronchiectasis patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with a confirmed diagnosis of bronchiectasis and a recent positive culture for Pseudomonas aeruginosa.

Not a fit: Patients who have chronic Pseudomonas aeruginosa infections that have not been isolated recently or those with other severe respiratory conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve lung function and quality of life for patients with bronchiectasis by effectively eradicating Pseudomonas aeruginosa infections.

How similar studies have performed: Previous studies in cystic fibrosis have shown success with similar eradication approaches, but this specific application in bronchiectasis is less established.

Eligibility criteria

Inclusion Criteria:

1. Male or female, aged 18 years and 80 years at screening
2. Signed and dated written informed consent prior to admission to the study in accordance with local legislation.
3. Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator-confirmed diagnosis of bronchiectasis by CT scan
4. During the screening period, patients must have a positive P. aeruginosa culture in their sputum 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 culture results at least twice before starting antibiotic treatment)
5. 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)
6. During the screening period, P. aeruginosa is not resistant to Tobramycin and Ciprofloxacin based on the drug sensitivity test of sputum culture in vitro
7. Patient can tolerate nebulized inhalation therapy

Exclusion criteria

1. Patients who are allergic to or cannot tolerate the investigational drugs (Tobramycin, Ciprofloxacin)
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. AST and/or ALT \>2 ULN at screening period
6. Serum creatinine \>ULN at 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 with a history of prolonged QT intervals or those whose electrocardiograms show prolonged QT intervals during the screening period
9. Participants who have used drugs that are prohibited according to the plan during the screening period.
10. Women of childbearing potential adhering to contraception requirements.
11. Patients with FEV1% of predicted value\<30%
12. Participants who have participated in other clinical trials (defined as those where medication has been administered) within the 4 weeks prior to the screening
13. 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.
14. Participants who are deemed unsuitable for inclusion in the study due to other reasons, as determined by the researcher.

Where this trial is running

Haikou, Hainan and 62 other locations

• Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (Recruiting)
• Qilu Hospital of Shandong University — Jinan, Shangdong, China (Recruiting)
• Ruijin Hospital — Shanghai, Shanghai, China (Recruiting)
• The Shanghai Fifth People's Hospital — Shanghai, Shanghai, China (Recruiting)
• Shanghai pulmonary hospital — Shanghai, Shanghai, China (Recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Recruiting)
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
• The Affiliated Hospital of Hangzhou Normal University — Hangzhou, Zhejiang, China (Recruiting)
• The First People's Hospital of Anning City Affiliated to Kunming University of Science and Technology — Anning, China (Recruiting)
• Beijing Chao-Yang Hospital, Capital Medical University — Beijing, China (Recruiting)
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, China (Recruiting)
• Peking University Third Hospital — Beijing, China (Suspended)
• The First Affiliated Hospital of Jilin University — Changchun, China (Recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, China (Recruiting)
• Xiangya Hospital, Central South University — Changsha, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, China (Recruiting)
• The Second Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)
• The Third Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)
• The Second Affiliated Hospital of Dalian Medical University — Dalian, China (Recruiting)
• Fujian Provincial Hospital — Fuzhou, China (Recruiting)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, China (Recruiting)
• The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine — Guangzhou, China (Recruiting)
• Guizhou Provincial People's Hospital — Guiyang, China (Recruiting)
• The Second Affiliated Hospital of Zhengjiang University — Hangzhou, China (Recruiting)
• Anhui Chest Hospital — Hefei, China (Recruiting)
• The First Affiliated Hospital of Anhui Medical University — Hefei, China (Recruiting)
• Huzhou Central Hospital — Huzhou, China (Recruiting)
• The First Hospital of Jiaxing City — Jiaxing, China (Recruiting)
• The Second Hospital of Jiaxing City — Jiaxing, China (Recruiting)
• The First Affiliated Hospital of Shandong First Medical University — Jinan, China (Recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Jinan, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, China (Recruiting)
• The Affiliated Sir Run Run Hospital of Nanjing Medical University — Nanjing, China (Suspended)
• The Second Affiliated Hospital of Nanjing Medical University — Nanjing, China (Recruiting)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, China (Recruiting)
• Affiliated Hospital, Nantong University — Nantong, China (Recruiting)
• The Sixth People's Hospital of Nantong City — Nantong, China (Recruiting)
• Fenghua District People's Hospital of Ningbo City — Ningbo, China (Recruiting)
• Ningbo Medical Center Lihuili Hospital — Ningbo, China (Recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, China (Recruiting)
• Qingdao Municipal Hospital — Qingdao, China (Recruiting)
• Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine — Shanghai, China (Recruiting)
• Shanghai Eighth People's Hospital — Shanghai, China (Recruiting)
• Shanghai General Hospital — Shanghai, China (Recruiting)
• Shanghai Putuo District People's Hospital — Shanghai, China (Recruiting)
• Shanghai Shidong Hospital of Yangpu District — Shanghai, China (Suspended)
• Shanghai Sixth People's Hospital — Shanghai, China (Not_yet_recruiting)
• Shanghai Songjiang District Central Hospital — Shanghai, China (Recruiting)
• Shanghai Yangpu District Central Hospital — Shanghai, China (Recruiting)
• Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)

Study contacts

• Principal investigator: Jin-Fu Xu, PhD — Shanghai Pulmonary Hospital, Shanghai, China
• Study coordinator: Jin-Fu Xu, PhD

Conditions Bronchiectasis Adult; Pseudomonas Aeruginosa Infection; bronchiectasis,; Pseudomonas Aeruginosa; eradication; inhaled antibiotics; randomized controlled trial