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COMPLETED

NCT06093191

PHASE4

Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis

Sponsor: Jin-Fu Xu

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 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).

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

371

Start Date

2023-10-18

Completion Date

2025-11-15

Last Updated

2026-04-17

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 high-resolution CT (HRCT) scan 4. Positive sputum culture for PA during screening, and meeting one of the following three conditions: ① No prior isolation of PA from respiratory secretions (a positive sputum culture from the study hospital within 1 month before screening was accepted, provided that no antibiotics were used for ≥14 days before the culture); ② First isolated PA within 12 months prior to screening, but did not undergo eradication therapy (continuous oral/intravenous/inhaled antibiotic treatment ≥1 month, excluding macrolides); ③ Previously isolated PA, but respiratory secretions were negative for PA at least twice (separated by an interval of ≥3 months) for 24 months or more prior to screening (Requirement: respiratory secretion isolation results obtained while not using antibiotics for 14 days or more); 5. 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) 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. 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; 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 and/or Total Bilirubin (TBIL) 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 who are pregnant or lactating, or women of childbearing potential preparing for pregnancy 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 (60)

Anhui Chest Hospital

Hefei, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The Third Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Fujian Provincial Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Shenzhen Institute of Respiratory Diseases

Shenzhen, Guangdong, China

The Eighth Affiliated Hospital of Sun Yat-Sen University

Shenzhen, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Hainan Provincial People's Hospital

Haikou, Hainan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Zhengzhou People's Hospital

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

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

Wuhan, Hubei, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Xiangya Hospital, Central South University

Changsha, Hunan, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

The Sixth People's Hospital of Nantong

Nantong, Jiangsu, China

Suzhou Hospital, Affiliated Hospital of Medical School, Nanjing University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Shangrao People's Hospital

Shangrao, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Tsingtao Municipal Hospital, Qingdao Hospital of University Health And Rehabilitation Sciences

Qingdao, Shandong, China

Qilu Hospital, Shandong University

Jinan, Shangdong, China

Ruijin Hospital, Shanghai Jiaotong University