Long-term Impact of Inhaled Tobramycin for Pseudomonas Aeruginosa Eradication in Bronchiectasis (ERASE II)

Extended Observational Study on the Long-term Impact of Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Patients With Bronchiectasis: The ERASE II Study

The ERASE II study is a prospective follow-up study designed to assess the long-term impact of successful eradication of Pseudomonas aeruginosa (PA) in patients with bronchiectasis. Building on the findings of the initial ERASE study, which evaluated the efficacy and safety of Tobramycin Inhalation Solution, ERASE II aims to determine whether successful PA eradication influences patient prognosis over an extended period.

The study will involve a total observation period of 36 months, consisting of the initial 9 months of the ERASE study followed by an additional 27 months of comprehensive follow-up. Key outcomes to be assessed include patients' quality of life, lung function, frequency of pulmonary exacerbations, frequency of hospitalization, and overall treatment costs. Additionally, the study will examine the timing and incidence of any potential reinfections with Pseudomonas aeruginosa.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis Adult
• Intervention / Treatment: Other: No Intervention: Observational Cohort

Detailed Description

Individuals with bronchiectasis are particularly susceptible to infections from Pseudomonas aeruginosa (PA), which can become chronic and lead to increased mortality and disease severity. To address this critical issue, we have designed a multi-center, 2×2 factorial randomized, double-blind, placebo-controlled trial known as the ERASE study. This trial aims to evaluate the efficacy and safety of Tobramycin Inhalation Solution in the eradication of Pseudomonas aeruginosa in bronchiectasis patients with newly or firstly isolated PA.

Building upon the findings of the ERASE study, the ERASE II study seeks to investigate whether successful eradication of PA influences the long-term prognosis of patients after the completion of the randomized controlled trial. To achieve this, we plan to extend the observation period to a total of 36 months, comprising the initial 9 months of the ERASE study, followed by an additional 27 months of comprehensive follow-up.

This extended observation period will enable us to assess the long-term impact of eradication therapy on various clinical outcomes, including patients' quality of life, lung function, frequency of pulmonary exacerbations, frequency of hospitalization, and overall economic treatment costs. Additionally, we will evaluate the timing of any potential reinfections/relapse with Pseudomonas aeruginosa, thereby providing valuable insights into the long-term benefits of eradication strategies in patients with bronchiectasis.

• Study Type: Observational
• Enrollment (Estimated): 364

Contacts and Locations

• Study Contact: Name: Jin-Fu Xu, PhD; Phone Number: +8613321922898; Email: jfxucn@163.com
• Study Contact Backup: Name: Jin-Fu Xu; Phone Number: +8613321922898; Email: jfxucn@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical University
      • Contact: Xiao-yun Fan, MD
      • Principal Investigator: Xiao-yun Fan, MD
    • Hefei, Anhui, China
      • Recruiting
      • Anhui Chest Hospital
      • Contact: Hua Niu, MD
      • Principal Investigator: Hua Niu, MD
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
      • Contact: Xin-lun Tian, MD
      • Principal Investigator: Xin-lun Tian, MD
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Chao-yang Hospital, Capital Medical University
      • Contact: Zhao-hui Tong, MD
      • Principal Investigator: Zhao-hui Tong, MD
  • Chongqing
    • Chongqing, Chongqing, China
      • Active, not recruiting
      • The Second Affiliated Hospital of Chongqing Medical University
    • Chongqing, Chongqing, China
      • Recruiting
      • The Third Affiliated Hospital of Chongqing Medical University
      • Contact: Chang-zheng Wang, MD
      • Principal Investigator: Chang-zheng Wang, MD
  • Fujiang
    • Fuzhou, Fujiang, China
      • Recruiting
      • Fujian Provincial Hospital
      • Contact: Bao-song Xie, MD
      • Principal Investigator: Bao-song Xie, MD
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Principal Investigator: Wei-jie Guan, PhD
      • Contact: Wei-jie Guan, PhD
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
      • Contact: Shao-feng Zhan, MD
      • Principal Investigator: Shao-feng Zhan, MD
    • Shenzhen, Guangdong, China
      • Recruiting
      • The Eighth Affiliated Hospital of Sun Yat-Sen University
      • Contact: Jian-quan Zhang, MD
      • Principal Investigator: Jian-quan Zhang, MD
    • Shenzhen, Guangdong, China
      • Recruiting
      • Shenzhen Institute of Respiratory Diseases
      • Contact: Ling-wei Wang, MD
      • Principal Investigator: Ling-wei Wang, MD
    • Zhanjiang, Guangdong, China
      • Active, not recruiting
      • Affiliated Hospital, Guangdong Medical College
  • Guangxi
    • Nanning, Guangxi, China
      • Active, not recruiting
      • The First Affiliated Hospital of Guangxi Medical University
  • Guizhou
    • GuiYang, Guizhou, China
      • Recruiting
      • Guizhou Provincial People's Hospital
      • Contact: Lin Liu, MD
      • Principal Investigator: Lin Liu, MD
  • Hainan
    • Haikou, Hainan, China
      • Active, not recruiting
      • Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
      • Contact: Xiao-ju Zhang, MD
      • Principal Investigator: Xiao-ju Zhang, MD
    • Zhengzhou, Henan, China
      • Recruiting
      • Zhengzhou People's Hospital
      • Contact: Jin-guang Jia, MD
      • Principal Investigator: Jin-guang Jia, MD
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Union hospital,Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Yang Jin, MD
      • Principal Investigator: Yang Jin, MD
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: Min Xie, MD
      • Principal Investigator: Min Xie, MD
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital, Central South University
      • Contact: Yuan-yuan Li, MD
      • Principal Investigator: Yuan-yuan Li, MD
    • Changsha, Hunan, China
      • Recruiting
      • The Second Xiangya Hospital of Central South University
      • Contact: Hong Luo, MD
      • Principal Investigator: Hong Luo, MD
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The Second Affiliated Hospital of Nanjing Medical University
      • Contact: Gan-zhu Feng, MD
      • Principal Investigator: Gan-zhu Feng, MD
    • Nantong, Jiangsu, China
      • Recruiting
      • Affiliated Hospital, Nantong University
      • Contact: Jian Feng, MD
      • Principal Investigator: Jian Feng, MD
    • Nantong, Jiangsu, China
      • Recruiting
      • The Sixth People's Hospital of Nantong City
      • Contact: Hong-yan Gu, MD
      • Principal Investigator: Hong-yan Gu, MD
    • Suzhou, Jiangsu, China
      • Recruiting
      • The First Affiliated Hospital of Soochow University
      • Contact: Jian-an Huang, MD
      • Principal Investigator: Jian-an Huang, MD
    • Suzhou, Jiangsu, China
      • Recruiting
      • Suzhou Science and Technology Town Hospital
      • Contact: Chao Yang, MD
      • Principal Investigator: Chao Yang, MD
    • Yangzhou, Jiangsu, China
      • Recruiting
      • Subei People's Hospital
      • Contact: Xing-xiang Xu, MD
      • Principal Investigator: Xing-xiang Xu
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • The First Affiliated Hospital of Nanchang University
      • Principal Investigator: Wei Zhang, MD
      • Contact: Wei Zhang, MD
      • Contact: Tian-xin Xiang, MD
    • Shangrao, Jiangxi, China
      • Recruiting
      • Shangrao People's Hospital
      • Contact: Qing-wei Meng, MD
      • Principal Investigator: Qing-wei Meng, MD
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The first Affiliated Hospital of Jilin University
      • Principal Investigator: Dan Li, MD
      • Contact: Dan Li, MD
  • Liaoning
    • Dalian, Liaoning, China
      • Recruiting
      • The Second Affiliated Hospital of Dalian Medical University
      • Contact: Qi Wang, MD
      • Principal Investigator: Qi Wang, MD
    • Shenyang, Liaoning, China
      • Recruiting
      • The First Affiliated Hospital of China Medical University
      • Principal Investigator: Wei Wang, MD
      • Contact: Wei Wang, MD
    • Shenyang, Liaoning, China
      • Recruiting
      • Shengjing Hospital of China Medical University
      • Principal Investigator: Yu Chen, MD
      • Contact: Yu Chen, MD
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • QiLU Hospital of ShanDong University
      • Contact: De-dong Ma, MD
      • Principal Investigator: De-dong Ma, MD
    • Qingdao, Shandong, China
      • Recruiting
      • Qingdao Municipal Hospital
      • Principal Investigator: Xue-dong Liu, MD
      • Contact: Xue-dong Liu, MD
  • Shangdong
    • Jinan, Shangdong, China
      • Active, not recruiting
      • The First Affiliated Hospital of Shandong First Medical University
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital
      • Principal Investigator: Jie-ming Qu, MD
      • Contact: Jie-ming Qu, MD
    • Shanghai, Shanghai, China, 200433
      • Recruiting
      • Shanghai Pulmonary Hospital
      • Contact: Jin-Fu Xu, PhD; Phone Number: +8613321922898; Email: jfxucn@163.com
      • Principal Investigator: Jin-Fu Xu, PhD
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Principal Investigator: Yuan-lin Song, MD
      • Contact: Yuan-lin Song, MD
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai sixth people's hospital
      • Contact: Tao Ren, MD
      • Principal Investigator: Tao Ren, MD
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Eighth People's Hospital
      • Contact: De-jie Chu, MD
      • Principal Investigator: De-jie Chu, MD
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai General Hospital
      • Contact: Min Zhang, MD
      • Principal Investigator: Min Zhang, MD
    • Shanghai, Shanghai, China, 200245
      • Recruiting
      • The Shanghai Fifth People's Hospital
      • Contact: Zhi-Jun Jie, MD
      • Principal Investigator: Zhi-Jun Jie, MD
    • Shanghai, Shanghai, China
      • Recruiting
      • Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine
      • Contact: Li Li, MD
      • Principal Investigator: Li Li, MD
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Putuo District People's Hospital
      • Contact: Feng-ying Zhang, MD
      • Principal Investigator: Feng-ying Zhang, MD
  • Shanxi
    • Taiyuan, Shanxi, China
      • Active, not recruiting
      • Shanxi Bethune Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Hong Fan, MD
      • Principal Investigator: Hong Fan, MD
  • Yunnan
    • Anning, Yunnan, China
      • Recruiting
      • The First People's Hospital of Anning City Affiliated to Kunming University of Science and Technology
      • Contact: Jian He, MD
      • Principal Investigator: Jian He, MD
    • Kunming, Yunnan, China
      • Active, not recruiting
      • The First Affiliated Hospital of Kunming Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Affiliated Hospital of Hangzhou Normal University
      • Contact: Qun Lv, MD
      • Principal Investigator: Qun Lv, MD
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital of Zhengjiang University
      • Principal Investigator: Wen Li, MD
      • Contact: Wen Li, MD
    • Huzhou, Zhejiang, China
      • Recruiting
      • Huzhou Central Hospital
      • Principal Investigator: Bin Wang, MD
      • Contact: Bin Wang, MD
    • Jiaxing, Zhejiang, China
      • Recruiting
      • The First Hospital of Jiaxing City
      • Contact: Xiao-dong Lv, MD
      • Principal Investigator: Xiao-dong Lv, MD
    • Jiaxing, Zhejiang, China
      • Active, not recruiting
      • The Second Hospital of Jiaxing City
    • Ningbo, Zhejiang, China
      • Recruiting
      • Ningbo Medical Center Lihuili Hospital
      • Contact: Jing-bo Jiang, MD
      • Principal Investigator: Jing-bo Jiang, MD
    • Ningbo, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Ningbo University
      • Contact: Chao Cao, MD
      • Principal Investigator: Chao Cao, MD
    • Ningbo, Zhejiang, China
      • Recruiting
      • Fenghua District People's Hospital of Ningbo City
      • Contact: Zhi Yuan, MD
      • Principal Investigator: Zhi Yuan, MD
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital of Wenzhou Medical University
      • Contact: Yu-ping Li, MD
      • Principal Investigator: Yu-ping Li, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have participate the ERASE study (NCT06093191)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients who successfully eradicate Pseudomonas aeruginosa in ERASE study; no intervention	Other: No Intervention: Observational Cohort; Observational study, no additional intervention
Patients who were not successful in eradicating Pseudomonas aeruginosa in the ERASE Study; No intervention	Other: No Intervention: Observational Cohort; Observational study, no additional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients successfully eradicating PA in each group at 15 months, defined as a negative sputum culture of PA at 6, 9, 12, 15 months.	The sputum culture will be performed in each group at 6, 9, 12, and 15 months after randomization	15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients with negative PA sputum cultures at 12 months following randomization, defined as a negative sputum culture of PA at 6, 9, and 12 months.	The sputum culture will be performed in each group at 6, 9, and 12 months after randomization	12 months
The proportion of patients with negative PA sputum cultures at 21 months following randomization, defined as a negative sputum culture of PA at 6, 9, 12, 15 and 21 months.	The sputum culture will be performed in each group at 6, 9, 12, 15 and 21 months after randomization	21 months
The proportion of patients with negative PA sputum cultures at 27 months following randomization, defined as a negative sputum culture of PA at 6, 9, 12, 15, 21 and 27 months.	The sputum culture will be performed in each group at 6, 9, 12, 15, 21 and 27 months after randomization	27 months
The proportion of patients with negative PA sputum cultures at 27 months following randomization, defined as a negative sputum culture of PA at 6, 9, 12, 15, 21, 27 and 36 months.	The sputum culture will be performed in each group at 6, 9, 12, 15, 21, 27 and 36 months after randomization	36 months
The differences in the frequency of pulmonary exacerbations of bronchiectasis at 12, 15, 21, 27, and 36 months following randomization.	The occurrences of pulmonary exacerbations will be documented during the follow-up period.	36 months
The differences in time to the first pulmonary exacerbation of bronchiectasis following randomization.	The occurrences of pulmonary exacerbations will be documented during the follow-up period.	36 months
The differences in the frequency of severe pulmonary exacerbations of bronchiectasis at 12, 15, 21, 27, and 36 months following randomization.	The occurrences of severe pulmonary exacerbations, defined as those requiring hospitalization, will be recorded during the follow-up period.	36 months
The differences in time to the first severe pulmonary exacerbation of bronchiectasis following randomization.	The occurrences of severe pulmonary exacerbations, defined as those requiring hospitalization, will be recorded during the follow-up period.	36 months
The changes in the QoL-B-RSS score from baseline in each group at 12, 15, 21, 27, and 36 months following randomization.	The QoL-B-RSS score will be recorded in each group at baseline, 12, 15, 21, 27, and 36 months following randomization. The Quality-of-Life-Bronchiectasis (QoL-B) questionnaire is a disease-specific survey designed for patients with bronchiectasis. The Respiratory Symptoms scale is a component of the QoL-B questionnaire, with a scale range from 0 to 100. Higher scores on this scale signify a better health status.	36 months
The changes in the SGRQ total score from baseline in each group at 12, 15, 21, 27, and 36 months following randomization.	The SGRQ total score will be recorded in each group at baseline, 12, 15, 21, 27, and 36 months following randomization. This questionnaire is structured into 3 main components: symptoms, activity and impacts. Scale range is 0-100, lower scores indicating better health status. Each component of the questionnaire is scored separately in three steps: i. The weights for all items with a positive responses are summed. ii. The weights for missed items are deducted from the maximum possible weight for each component. The weights for all missed items are deducted from the maximum possible weight for the Total score. iii. The score is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage The Total score is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing result as a percentage The Total score is calculated in similar way.	36 months
The changes of Euroqual-5 Dimensions questionnaire following randomization.	The (EQ-5D-5L) scale will be assessed at baseline, 12, 15, 21, 27, and 36 months following randomization.The Euroqual-5 Dimensions questionnaire (EQ-5D) consists of two parts: health state description and evaluation. In the description part, health status is measured across five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Respondents rate their severity level for each dimension using a five-level (EQ-5D-5L) scale. In the evaluation part, respondents assess their overall health status using the visual analogue scale (EQ-VAS), which ranges from 0 to 100, with higher scores indicating a better health status. Health states defined by the EQ-5D-5L descriptive system are converted into index values. This facilitates the calculation of Quality-Adjusted Life Years (QALYs), which are used to inform economic evaluations of healthcare interventions, according to guidelines found at https://euroqol.org.	36 months
Daily Symptoms Measured by the bronchiectasis exacerbation and symptom tool (BEST)	Daily Symptoms were recorded by the bronchiectasis exacerbation and symptom tool (BEST)	27
Changes in forced expiratory volume in 1 second [FEV1] at 12, 21, 27 and 36 months compared with baseline	Changes in forced expiratory volume in 1 second [FEV1] at 12, 21, 27 and 36 months compared with baseline	36 months
Changes in forced vital capacity [FVC] at 12, 21, 27 and 36 months compared with baseline	Changes in forced vital capacity [FVC] at 12, 21, 27 and 36 months compared with baseline	36 months
Changes in forced expiratory flow at 25-75% of forced vital capacity at 12, 21, 27 and 36 months compared with baseline	Changes in forced expiratory flow at 25-75% of forced vital capacity at 12, 21, 27 and 36 months compared with baseline	36 months
The cost of hospitalization during the follow-up period	The cost of hospitalization during the whole study period	36 months

Collaborators and Investigators

• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China
• Investigators: Principal Investigator: Jin-Fu Xu, PhD, Huadong Hospital affiliated with Fudan University

Publications and helpful links

General Publications

• 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.
• Conceicao M, Shteinberg M, Goeminne P, Altenburg J, Chalmers JD. Eradication treatment for Pseudomonas aeruginosa infection in adults with bronchiectasis: a systematic review and meta-analysis. Eur Respir Rev. 2024 Jan 31;33(171):230178. doi: 10.1183/16000617.0178-2023. Print 2024 Jan 31.
• Gao YH, Lu HW, Zheng HZ, Cao C, Chu DJ, Fan H, Fan XY, Gu HY, Guan WJ, Jie ZJ, Jin Y, Li W, Li YP, Li YY, Liu L, Liu XD, Luo H, Lv XD, Mo WQ, Song YL, Wang DX, Wang LW, Wang CZ, Xie M, Zhang M, Zheng CX, Mao B, Chotirmall SH, Chalmers JD, Qu JM, Xu JF. A phase 4 multicentre, 2x2 factorial randomised, double-blind, placebo-controlled trial to investigate the efficacy and safety of tobramycin inhalation solution for Pseudomonas aeruginosa eradication in bronchiectasis: ERASE. ERJ Open Res. 2024 Feb 26;10(1):00938-2023. doi: 10.1183/23120541.00938-2023. eCollection 2024 Jan.
• 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.

Helpful Links

• An extended observational study of the ERASE study

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: December 29, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 30, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Eradication; Observational study; bronchiectasis; Pseudomonas Aeruginosa; Long-term impact
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bronchial Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Bronchiectasis; Pseudomonas Infections
• Other Study ID Numbers: 20230329-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No