Long-term effects of inhaled Tobramycin on bronchiectasis patients
Extended Observational Study on the Long-term Impact of Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Patients With Bronchiectasis: The ERASE II Study
This study is testing the long-term effects of a treatment that clears a specific lung infection in people with bronchiectasis to see how it improves their quality of life and lung health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 364 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Pulmonary Hospital, Shanghai, China Academic / other |
| Locations | 58 sites (Hefei, Anhui and 57 other locations) |
| Trial ID | NCT06760273 on ClinicalTrials.gov |
What this trial studies
The ERASE II study is a prospective observational study that aims to evaluate the long-term impact of successfully eradicating Pseudomonas aeruginosa in patients with bronchiectasis. Following an initial 9-month period of the ERASE study, this study will extend observation for an additional 27 months to assess various outcomes such as quality of life, lung function, and frequency of pulmonary exacerbations. The study will also monitor the incidence of reinfections with Pseudomonas aeruginosa, providing insights into the long-term benefits of eradication therapy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with bronchiectasis who have participated in the initial ERASE study and provided informed consent.
Not a fit: Patients who were lost to follow-up in the ERASE study or deemed ineligible by the researcher may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the long-term health outcomes and quality of life for patients with bronchiectasis by demonstrating the benefits of eradicating Pseudomonas aeruginosa.
How similar studies have performed: Previous studies have shown promising results in the efficacy of Tobramycin for eradicating Pseudomonas aeruginosa, making this follow-up study a valuable continuation of that research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * all patients who participate the ERSE study * write the informed consent form. Exclusion Criteria: * patients who were lost of follow up in the ERASE study * ineligible for inclusion at the discretion of the researcher for other reasons.
Where this trial is running
Hefei, Anhui and 57 other locations
- Anhui Chest Hospital — Hefei, Anhui, China (Recruiting)
- The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China (Recruiting)
- Beijing Chao-Yang Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
- The Second Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Active_not_recruiting)
- The Third Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China (Recruiting)
- Fujian Provincial Hospital — Fuzhou, Fujiang, China (Recruiting)
- The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
- The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine — Guangzhou, Guangdong, China (Recruiting)
- Shenzhen Institute of Respiratory Diseases — Shenzhen, Guangdong, China (Recruiting)
- The Eighth Affiliated Hospital of Sun Yat-Sen University — Shenzhen, Guangdong, China (Recruiting)
- Affiliated Hospital, Guangdong Medical College — Zhanjiang, Guangdong, China (Active_not_recruiting)
- The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Active_not_recruiting)
- Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Recruiting)
- Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University — Haikou, Hainan, China (Active_not_recruiting)
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
- Zhengzhou People's Hospital — Zhengzhou, Henan, China (Recruiting)
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- Union Hospital,Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
- The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Recruiting)
- Xiangya Hospital, Central South University — Changsha, Hunan, China (Recruiting)
- The Second Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
- Affiliated Hospital, Nantong University — Nantong, Jiangsu, China (Recruiting)
- The Sixth People's Hospital of Nantong City — Nantong, Jiangsu, China (Recruiting)
- Suzhou Science and Technology Town Hospital — Suzhou, Jiangsu, China (Recruiting)
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
- Subei People's Hospital — Yangzhou, Jiangsu, China (Recruiting)
- The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
- Shangrao People's Hospital — Shangrao, Jiangxi, China (Recruiting)
- The First Affiliated Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
- The Second Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
- Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
- The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
- Qingdao Municipal Hospital — Qingdao, Shandong, China (Recruiting)
- The First Affiliated Hospital of Shandong First Medical University — Jinan, Shangdong, China (Active_not_recruiting)
- Ruijin Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- The Shanghai Fifth People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai pulmonary hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai Eighth People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai Putuo District People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
- Zhongshan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Active_not_recruiting)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
- The First People's Hospital of Anning City Affiliated to Kunming University of Science and Technology — Anning, Yunnan, China (Recruiting)
- The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Active_not_recruiting)
- The Affiliated Hospital of Hangzhou Normal University — Hangzhou, Zhejiang, China (Recruiting)
+8 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Principal investigator: Jin-Fu Xu, PhD — Huadong Hospital affiliated with Fudan University
- Study coordinator: Jin-Fu Xu
- Email: jfxucn@163.com
- Phone: +8613321922898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.