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RECRUITING

NCT06093191

PHASE4

Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis

Sponsor: Shanghai Pulmonary Hospital, Shanghai, China

View on ClinicalTrials.gov

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 rates of PA, defined as a negative sputum culture of PA at both 24 weeks and 36 weeks.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

364

Start Date

2023-09-25

Completion Date

2025-12-30

Last Updated

2024-12-18

Healthy Volunteers

Conditions

Bronchiectasis Adult Pseudomonas Aeruginosa Infection

Interventions

DRUG

Tobramycin Inhalant Product

Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.

DRUG

Ciprofloxacin 750 MG

Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.

DRUG

Oral ciprofloxacin placebo

Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.

DRUG

Natural saline inhalation

Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.

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.

Locations (63)

Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University

Haikou, Hainan, China

Qilu Hospital of Shandong University

Jinan, Shangdong, China

Ruijin Hospital

Shanghai, Shanghai Municipality, China

The Shanghai Fifth People's Hospital

Shanghai, Shanghai Municipality, China

Shanghai pulmonary hospital

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China

The First People's Hospital of Anning City Affiliated to Kunming University of Science and Technology

Anning, China

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, China

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China

Peking University Third Hospital

Beijing, China

The First Affiliated Hospital of Jilin University

Changchun, China

The Second Xiangya Hospital of Central South University

Changsha, China

Xiangya Hospital, Central South University

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, China

The Third Affiliated Hospital of Chongqing Medical University

Chongqing, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, China

Fujian Provincial Hospital

Fuzhou, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, China

Guizhou Provincial People's Hospital

Guiyang, China

The Second Affiliated Hospital of Zhengjiang University

Hangzhou, China

Anhui Chest Hospital

Hefei, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Huzhou Central Hospital

Huzhou, China

The First Hospital of Jiaxing City

Jiaxing, China

The Second Hospital of Jiaxing City

Jiaxing, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, China

The First Affiliated Hospital of Wenzhou Medical University

Jinan, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Affiliated Sir Run Run Hospital of Nanjing Medical University

Nanjing, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Affiliated Hospital, Nantong University

Nantong, China

The Sixth People's Hospital of Nantong City

Nantong, China

Fenghua District People's Hospital of Ningbo City

Ningbo, China

Ningbo Medical Center Lihuili Hospital

Ningbo, China

The First Affiliated Hospital of Ningbo University

Ningbo, China

Qingdao Municipal Hospital

Qingdao, China

Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine

Shanghai, China

Shanghai Eighth People's Hospital

Shanghai, China

Shanghai General Hospital

Shanghai, China

Shanghai Putuo District People's Hospital

Shanghai, China

Shanghai Shidong Hospital of Yangpu District

Shanghai, China

Shanghai Sixth People's Hospital

Shanghai, China

Shanghai Songjiang District Central Hospital

Shanghai, China

Shanghai Yangpu District Central Hospital

Shanghai, China

Zhongshan Hospital, Fudan University

Shanghai, China

Shangrao People's Hospital

Shangrao, China

Shengjing Hospital of China Medical University

Shenyang, China

The First Affiliated Hospital of China Medical University

Shenyang, China

Shenzhen Institute of Respiratory Diseases

Shenzhen, China

The Eighth Affiliated Hospital of Sun Yat-Sen University

Shenzhen, China

Suzhou Science and Technology Town Hospital

Suzhou, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Union Hospital,Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

Subei People's Hospital

Yangzhou, China

Affiliated Hospital, Guangdong Medical College

Zhanjiang, China

Henan Provincial People's Hospital

Zhengzhou, China

Zhengzhou People's Hospital

Zhengzhou, China

Clinical Research Directory

Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (63)