Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis
ERASE
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
1 other identifier
interventional
371
1 country
60
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Oct 2023
Typical duration for phase_4
60 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2023
CompletedStudy Start
First participant enrolled
October 18, 2023
CompletedFirst Posted
Study publicly available on registry
October 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2025
CompletedApril 17, 2026
April 1, 2026
2 years
October 10, 2023
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
The proportion of subjects with sustained negative sputum cultures for Pseudomonas aeruginosa after first drug administration. This is defined as negative sputum culture results on two consecutive occasions separated by an interval of 12 weeks or more.
36 weeks
Secondary Outcomes (20)
Proportion of patients with a negative Pseudomonas aeruginosa sputum culture at 12 weeks after the first drug administration.
12 weeks
Proportion of patients with a negative Pseudomonas aeruginosa sputum culture at 24 weeks after the first drug administration.
24 weeks
Proportion of patients with a negative Pseudomonas aeruginosa sputum culture at 36 weeks after the first drug administration.
36 weeks
Time to first pulmonary exacerbation of bronchiectasis after the first drug administration.
36 weeks
Frequency of pulmonary exacerbations of bronchiectasis after the first drug administration.
12 weeks
- +15 more secondary outcomes
Study Arms (4)
Combination group
ACTIVE COMPARATORParticipants will receive inhaled 300mg of tobramycin solution twice daily for 12 weeks and oral 750mg of ciprofloxacin twice daily for 2 weeks
Tobramycin inhalation solution alone group
ACTIVE COMPARATORParticipants will receive inhaled 300mg of tobramycin twice daily for 12 weeks and oral ciprofloxacin placebo twice daily for 2 weeks
Oral ciprofloxacin alone group
ACTIVE COMPARATORParticipants will receive oral 750mg of ciprofloxacin twice daily for 2 weeks and inhaled saline twice daily for 12 weeks
Placebo group
PLACEBO COMPARATORParticipants will receive inhaled saline twice daily for 12 weeks and oral ciprofloxacin placebo twice daily for 2 weeks
Interventions
Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.
Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.
Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.
Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.
Eligibility Criteria
You may qualify if:
- 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:
- 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);
- 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
You may not qualify if:
- Patients who are allergic to or cannot tolerate the investigational drugs (Tobramycin, Ciprofloxacin)
- 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
- Participants who have used drugs that are prohibited according to the plan during the screening period.
- Women who are pregnant or lactating, or women of childbearing potential preparing for pregnancy
- Patients with FEV1% of predicted value\<30%
- Participants who have participated in other clinical trials (defined as those where medication has been administered) within the 4 weeks prior to the screening
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jin-Fu Xulead
Study Sites (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, 570311, 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
Shanghai, Shanghai Municipality, 200025, China
Tongji Hospital, School of Medicine, Tongji University; Shanghai Pulmonary Hospital, School of Medicine, Tongji University; Huadong Hospital, School of Medicine, Fudan University
Shanghai, Shanghai Municipality, 200065; 200433; 200040, China
Shanghai Fifth People's Hospital, Fudan University
Shanghai, Shanghai Municipality, 200245, China
Baoshan Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Putuo People's Hospital, School of Medicine, Tongji University
Shanghai, Shanghai Municipality, China
Shanghai General Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Songjiang Hospital, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
The Eighth People's Hospital of Shanghai
Shanghai, Shanghai Municipality, China
Yangpu Hospital, Tongji University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The First People's Hospital of Anning Affiliated to Kunming University of Science and Technology
Anning, Yunnan, China
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Huzhou Central Hospital Affiliated to Zhejiang University School of Medicine
Huzhou, Zhejiang, China
Affiliated Hospital of Jiaxing University
Jiaxing, Zhejiang, China
Medical Service Community of People's Hospital of Fenghua
Ningbo, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Affliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
The Second Affiliated Hospital of Jiaxing University
Jiaxing, China
Shanghai Sixth People's Hospital, Shanghai Jiao Tong University
Shanghai, China
Related Publications (8)
Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
PMID: 28889110BACKGROUNDHill AT, Sullivan AL, Chalmers JD, De Soyza A, Elborn SJ, Floto AR, Grillo L, Gruffydd-Jones K, Harvey A, Haworth CS, Hiscocks E, Hurst JR, Johnson C, Kelleher PW, Bedi P, Payne K, Saleh H, Screaton NJ, Smith M, Tunney M, Whitters D, Wilson R, Loebinger MR. British Thoracic Society Guideline for bronchiectasis in adults. Thorax. 2019 Jan;74(Suppl 1):1-69. doi: 10.1136/thoraxjnl-2018-212463. No abstract available.
PMID: 30545985BACKGROUNDAliberti S, Masefield S, Polverino E, De Soyza A, Loebinger MR, Menendez R, Ringshausen FC, Vendrell M, Powell P, Chalmers JD; EMBARC Study Group. Research priorities in bronchiectasis: a consensus statement from the EMBARC Clinical Research Collaboration. Eur Respir J. 2016 Sep;48(3):632-47. doi: 10.1183/13993003.01888-2015. Epub 2016 Jun 10.
PMID: 27288031BACKGROUNDWhite L, Mirrani G, Grover M, Rollason J, Malin A, Suntharalingam J. Outcomes of Pseudomonas eradication therapy in patients with non-cystic fibrosis bronchiectasis. Respir Med. 2012 Mar;106(3):356-60. doi: 10.1016/j.rmed.2011.11.018. Epub 2011 Dec 26.
PMID: 22204744BACKGROUNDVallieres E, Tumelty K, Tunney MM, Hannah R, Hewitt O, Elborn JS, Downey DG. Efficacy of Pseudomonas aeruginosa eradication regimens in bronchiectasis. Eur Respir J. 2017 Apr 12;49(4):1600851. doi: 10.1183/13993003.00851-2016. Print 2017 Apr. No abstract available.
PMID: 28404646BACKGROUNDBlanco-Aparicio M, Saleta Canosa JL, Valino Lopez P, Martin Egana MT, Vidal Garcia I, Montero Martinez C. Eradication of Pseudomonas aeruginosa with inhaled colistin in adults with non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2019 Jan-Dec;16:1479973119872513. doi: 10.1177/1479973119872513.
PMID: 31480862BACKGROUNDOrriols R, Hernando R, Ferrer A, Terradas S, Montoro B. Eradication Therapy against Pseudomonas aeruginosa in Non-Cystic Fibrosis Bronchiectasis. Respiration. 2015;90(4):299-305. doi: 10.1159/000438490. Epub 2015 Sep 5.
PMID: 26340658BACKGROUNDPieters A, Bakker M, Hoek RAS, Altenburg J, van Westreenen M, Aerts JGJV, van der Eerden MM. The clinical impact of Pseudomonas aeruginosa eradication in bronchiectasis in a Dutch referral centre. Eur Respir J. 2019 Apr 11;53(4):1802081. doi: 10.1183/13993003.02081-2018. Print 2019 Apr. No abstract available.
PMID: 30635292BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Fu Xu, MD, PhD
Tongji Hospital, School of Medicine, Tongji University; Shanghai Pulmonary Hospital, School of Medicine, Tongji University; Huadong Hospital, School of Medicine, Fudan University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Both investigators and participants were blinded to the treatment assignment throughout the study. To maintain this blinding, placebos were used, which were made indistinguishable in appearance from the inhaled tobramycin solution and oral ciprofloxacin. The taste of the inhaled tobramycin solution was not disclosed to the patients, and neither the patients nor most clinicians had prior knowledge of its taste. This blinding approach ensures that both participants and investigators remain unaware of the specific treatment each patient is receiving, thereby reducing potential biases in the study's results
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 10, 2023
First Posted
October 23, 2023
Study Start
October 18, 2023
Primary Completion
October 28, 2025
Study Completion
November 15, 2025
Last Updated
April 17, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share