New hope for lung infection sufferers: inhaled antibiotic trial shows promise

NCT ID NCT06093191

Disease control Sponsor: Jin-Fu Xu Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether an inhaled antibiotic (tobramycin), taken alone or with an oral antibiotic (ciprofloxacin), can permanently clear Pseudomonas aeruginosa infections from the lungs of people with bronchiectasis. The trial involved 371 adults and compared these treatments to a placebo (inhaled saline). The goal was to see if the infection could be eliminated for at least 12 weeks, potentially reducing disease severity and death risk.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

371 people

The number who actually took part.

Started

Oct 2023

Finished

Nov 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bronchiectasis Pseudomonas aeruginosa infectious disease Pseudomonas infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bronchiectasis adult Pseudomonas aeruginosa infection

Contacts and locations

Locations

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China
Affiliated Hospital of Jiaxing University

Jiaxing, Zhejiang, China
Affiliated Hospital of Nantong University

Nantong, Jiangsu, China
Anhui Chest Hospital

Hefei, Anhui, China
Baoshan Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China
Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, China
Fujian Provincial Hospital

Fuzhou, Fujian, 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
Huzhou Central Hospital Affiliated to Zhejiang University School of Medicine

Huzhou, Zhejiang, China
Medical Service Community of People's Hospital of Fenghua

Ningbo, Zhejiang, China
Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China
Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, China
Peking Union Medical College Hospital

Beijing, Beijing Municipality, China
Putuo People's Hospital, School of Medicine, Tongji University

Shanghai, Shanghai Municipality, China
Qilu Hospital, Shandong University

Jinan, Shangdong, China
Ruijin Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200025, China
Shanghai Fifth People's Hospital, Fudan University

Shanghai, Shanghai Municipality, 200245, China
Shanghai General Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital, Shanghai Jiao Tong University

Shanghai, China
Shanxi Bethune Hospital

Taiyuan, Shanxi, 030032, China
Shengjing Hospital of China Medical University

Shenyang, Liaoning, China
Shenzhen Institute of Respiratory Diseases

Shenzhen, Guangdong, China
Songjiang Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China
Suzhou Hospital, Affiliated Hospital of Medical School, Nanjing University

Suzhou, Jiangsu, China
The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, China
The Eighth Affiliated Hospital of Sun Yat-Sen University

Shenzhen, Guangdong, China
The Eighth People's Hospital of Shanghai

Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China
The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 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
The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650032, China
The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China
The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China
The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China
The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China
The First Affliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China
The First Hospital of China Medical University

Shenyang, Liaoning, China
The First Hospital of Jilin University

Changchun, Jilin, China
The First People's Hospital of Anning Affiliated to Kunming University of Science and Technology

Anning, Yunnan, China
The Second Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China
The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China
The Second Affiliated Hospital of Jiaxing University

Jiaxing, China
The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China
The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, China
The Shangrao People's Hospital

Shangrao, Jiangxi, China
The Sixth People's Hospital of Nantong

Nantong, Jiangsu, China
The Third Affiliated Hospital of Chongqing Medical University

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

Wuhan, Hubei, China
Tsingtao Municipal Hospital, Qingdao Hospital of University Health And Rehabilitation Sciences

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

Wuhan, Hubei, China
West China Hospital, Sichuan University

Chengdu, Sichuan, China
Xiangya Hospital, Central South University

Changsha, Hunan, China
Yangpu Hospital, Tongji University

Shanghai, Shanghai Municipality, China
Zhengzhou People's Hospital

Zhengzhou, Henan, China
Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

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