Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Bronchiectasis
NCT ID: NCT06093191
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
364 participants
INTERVENTIONAL
2023-09-25
2025-12-30
Brief Summary
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Detailed Description
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In cystic fibrosis, early infection with PA is clearly linked to worse outcomes, and eradication is associated with clinical benefits, including improved lung function and reduced hospitalization. Small sample observational studies have shown that eradication therapy following initial PA isolation is efficient, with eradication rates of 40%-57% in bronchiectasis. Therefore, a randomized control trial of PA eradication therapy is needed to determine the microbiological and clinical outcomes of this therapy.
There is also uncertainty about whether inhaled antibiotics alone are sufficient to eradicate PA in non-cystic fibrosis bronchiectasis, given the less severe nature of the disease compared to cystic fibrosis. It's unclear whether adding another antibiotic, such as oral ciprofloxacin in this study, to inhaled antibiotics at the initial stage is necessary as an enhanced treatment for eradicating PA in bronchiectasis.
To address these knowledge gaps, a multicenter, 2×2 factorial randomized, double-blind, placebo-controlled, parallel-group study is designed in bronchiectasis patients with newly or firstly isolated PA. This study aims to investigate the efficacy and safety of tobramycin inhalation solution alone or in combination with oral ciprofloxacin in eradicating PA in bronchiectasis.
Patients will be randomly assigned to one of four groups:
1. Placebo group: participants will receive inhaled saline twice daily for 12 weeks and an oral ciprofloxacin placebo twice daily for 2 weeks.
2. Oral ciprofloxacin alone group: participants will receive 750mg of oral ciprofloxacin twice daily for 2 weeks and inhaled saline twice daily for 12 weeks.
3. Tobramycin inhalation solution alone group: participants will receive 300mg of inhaled tobramycin twice daily for 12 weeks and an oral ciprofloxacin placebo twice daily for 2 weeks.
4. Combination group: participants will receive 300mg of inhaled tobramycin solution twice daily for 12 weeks and 750mg of oral ciprofloxacin twice daily for 2 weeks.
This study will provide valuable insights into the most effective treatment strategy for eradicating PA in bronchiectasis patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Combination group
Participants will receive inhaled 300mg of tobramycin solution twice daily for 12 weeks and oral 750mg of ciprofloxacin twice daily for 2 weeks
Tobramycin Inhalant Product
Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.
Ciprofloxacin 750 MG
Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.
Tobramycin inhalation solution alone group
Participants will receive inhaled 300mg of tobramycin twice daily for 12 weeks and oral ciprofloxacin placebo twice daily for 2 weeks
Tobramycin Inhalant Product
Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.
Oral ciprofloxacin placebo
Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.
Oral ciprofloxacin alone group
Participants will receive oral 750mg of ciprofloxacin twice daily for 2 weeks and inhaled saline twice daily for 12 weeks
Ciprofloxacin 750 MG
Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.
Natural saline inhalation
Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.
Placebo group
Participants will receive inhaled saline twice daily for 12 weeks and oral ciprofloxacin placebo twice daily for 2 weeks
Oral ciprofloxacin placebo
Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.
Natural saline inhalation
Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.
Interventions
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Tobramycin Inhalant Product
Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.
Ciprofloxacin 750 MG
Oral ciprofloxacin 750mg twice daily will be prescribed for 2 weeks.
Oral ciprofloxacin placebo
Oral ciprofloxacin placebo twice daily will be prescribed for 2 weeks.
Natural saline inhalation
Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of 12 weeks therapy will be scheduled.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Shanghai Pulmonary Hospital, Shanghai, China
OTHER
Responsible Party
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Jin-Fu Xu
Professor
Principal Investigators
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Jin-Fu Xu, PhD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Pulmonary Hospital, Shanghai, China
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Yi-peng Ding, MD
Role: primary
De-dong Ma, MD
Role: primary
Jie-ming Qu, MD
Role: primary
Zhi-jun Jie, MD
Role: primary
Jin-Fu Xu, MD
Role: primary
Xian-sheng Liu, MD
Role: primary
Zhuang Luo, MD
Role: primary
Qun Lv, MD
Role: primary
Jian He, MD
Role: primary
Zhao-hui Tong, MD
Role: primary
Xin-lun Tian, MD
Role: primary
Dan Li, MD
Role: primary
Hong Luo, MD
Role: primary
Yuan-yuan Li, MD
Role: primary
Hong Fan, MD
Role: primary
Dao-xin Wang, MD
Role: primary
Chang-zheng Wang, MD
Role: primary
Qi Wang, MD
Role: primary
Bao-song Xie, MD
Role: primary
Wei-jie Guan, MD
Role: primary
Shao-feng Zhan, MD
Role: primary
Lin Liu, MD
Role: primary
Wen Li, MD
Role: primary
Hua Niu, MD
Role: primary
Xiao-yun Fan, MD
Role: primary
Bin Wang, MD
Role: primary
Xiao-dong Lv, MD
Role: primary
Wei-qiang Mo, MD
Role: primary
Liang Dong, MD
Role: primary
Yu-ping Li, MD
Role: primary
Wei Zhang, MD
Role: primary
Tian-xin Xiang, MD
Role: backup
Gan-zhu Feng, MD
Role: primary
Jing-min Deng, MD
Role: primary
Jian Feng, MD
Role: primary
Hong-yan Gu, MD
Role: primary
Zhi Yuan, MD
Role: primary
Jing-bo Jiang, MD
Role: primary
Chao Cao, MD
Role: primary
Xue-dong Liu, MD
Role: primary
Li Li, MD
Role: primary
De-jie Chu, MD
Role: primary
Min Zhang, MD
Role: primary
Feng-ying Zhang, MD
Role: primary
Tao Ren, MD
Role: primary
Fan Li, MD
Role: primary
Cui-xia Zheng, MD
Role: primary
Yuan-lin Song, MD
Role: primary
Qing-wei Meng, MD
Role: primary
Yu Chen, MD
Role: primary
Wei Wang, MD
Role: primary
Ling-wei Wang, MD
Role: primary
Jian-quan Zhang, MD
Role: primary
Chao Yang, MD
Role: primary
Jian-an Huang, MD
Role: primary
Min Xie, MD
Role: primary
Yang Jin, MD
Role: primary
Xing-xiang Xu, MD
Role: primary
Bin Wu, MD
Role: primary
Xiao-ju Zhang, MD
Role: primary
Jin-guang Jia, MD
Role: primary
References
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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.
Hill 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.
Aliberti 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.
White 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.
Vallieres 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.
Blanco-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.
Orriols 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.
Pieters 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.
Other Identifiers
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20230329
Identifier Type: -
Identifier Source: org_study_id