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Bronchiectasis AdultNCT06760273

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

An observational study of Bronchiectasis Adult, run by Shanghai Pulmonary Hospital, Shanghai, China at 58 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Bronchiectasis Adult
How many people
364 participants
Where
58 sitesChina
Study dates
16 Oct 2024to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients who have participate the ERASE study (NCT06093191)

Who may be able to join

  • all patients who participate the ERSE study
  • write the informed consent form.

Who cannot join

  • patients who were lost of follow up in the ERASE study
  • ineligible for inclusion at the discretion of the researcher for other reasons.

Trial locations and contacts

58 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jin-Fu Xu, PhD contact

+8613321922898

jfxucn@163.com

58 sites in 1 country

China58 sites, 50 recruiting
  • The First People's Hospital of Anning City Affiliated to Kunming University of Science and Technology

    Anning, Yunnan

    Jian He, MD

    Jian He, MD

    Recruiting
  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality

    Zhao-hui Tong, MD

    Zhao-hui Tong, MD

    Recruiting
  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Xin-lun Tian, MD

    Xin-lun Tian, MD

    Recruiting
  • The First Affiliated Hospital of Jilin University

    Changchun, Jilin

    Dan Li, MD

    Dan Li, MD

    Recruiting
  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Hong Luo, MD

    Hong Luo, MD

    Recruiting
  • Xiangya Hospital, Central South University

    Changsha, Hunan

    Yuan-yuan Li, MD

    Yuan-yuan Li, MD

    Recruiting
  • West China Hospital of Sichuan University

    Chengdu, Sichuan

    Hong Fan, MD

    Hong Fan, MD

    Recruiting
  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Active, not recruiting
  • The Third Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Chang-zheng Wang, MD

    Chang-zheng Wang, MD

    Recruiting
  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning

    Qi Wang, MD

    Qi Wang, MD

    Recruiting
  • Fujian Provincial Hospital

    Fuzhou, Fujiang

    Bao-song Xie, MD

    Bao-song Xie, MD

    Recruiting
  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

    Wei-jie Guan, PhD

    Wei-jie Guan, PhD

    Recruiting
  • The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

    Guangzhou, Guangdong

    Shao-feng Zhan, MD

    Shao-feng Zhan, MD

    Recruiting
  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou

    Lin Liu, MD

    Lin Liu, MD

    Recruiting
  • Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University

    Haikou, Hainan

    Active, not recruiting
  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang

    Qun Lv, MD

    Qun Lv, MD

    Recruiting
  • The Second Affiliated Hospital of Zhengjiang University

    Hangzhou, Zhejiang

    Wen Li, MD

    Wen Li, MD

    Recruiting
  • Anhui Chest Hospital

    Hefei, Anhui

    Hua Niu, MD

    Hua Niu, MD

    Recruiting
  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Xiao-yun Fan, MD

    Xiao-yun Fan, MD

    Recruiting
  • Huzhou Central Hospital

    Huzhou, Zhejiang

    Bin Wang, MD

    Bin Wang, MD

    Recruiting
  • The First Hospital of Jiaxing City

    Jiaxing, Zhejiang

    Xiao-dong Lv, MD

    Xiao-dong Lv, MD

    Recruiting
  • The Second Hospital of Jiaxing City

    Jiaxing, Zhejiang

    Active, not recruiting
  • Qilu Hospital of Shandong University

    Jinan, Shandong

    De-dong Ma, MD

    De-dong Ma, MD

    Recruiting
  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shangdong

    Active, not recruiting
  • The First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan

    Active, not recruiting
  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Wei Zhang, MD

    Tian-xin Xiang, MD

    Recruiting
  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Gan-zhu Feng, MD

    Gan-zhu Feng, MD

    Recruiting
  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Active, not recruiting
  • Affiliated Hospital, Nantong University

    Nantong, Jiangsu

    Jian Feng, MD

    Jian Feng, MD

    Recruiting
  • The Sixth People's Hospital of Nantong City

    Nantong, Jiangsu

    Hong-yan Gu, MD

    Hong-yan Gu, MD

    Recruiting
  • Fenghua District People's Hospital of Ningbo City

    Ningbo, Zhejiang

    Zhi Yuan, MD

    Zhi Yuan, MD

    Recruiting
  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang

    Jing-bo Jiang, MD

    Jing-bo Jiang, MD

    Recruiting
  • The First Affiliated Hospital of Ningbo University

    Ningbo, Zhejiang

    Chao Cao, MD

    Chao Cao, MD

    Recruiting
  • Qingdao Municipal Hospital

    Qingdao, Shandong

    Xue-dong Liu, MD

    Xue-dong Liu, MD

    Recruiting
  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

    Jie-ming Qu, MD

    Jie-ming Qu, MD

    Recruiting
  • The Shanghai Fifth People's Hospital

    Shanghai, Shanghai Municipality, 200245

    Zhi-Jun Jie, MD

    Zhi-Jun Jie, MD

    Recruiting
  • Shanghai pulmonary hospital

    Shanghai, Shanghai Municipality, 200433

    Jin-Fu Xu, PhD, +8613321922898, jfxucn@163.com

    Jin-Fu Xu, PhD

    Recruiting
  • Baoshan District Hospital of Integrated Traditional Chinese and Western Medicine

    Shanghai, Shanghai Municipality

    Li Li, MD

    Li Li, MD

    Recruiting
  • Shanghai Eighth People's Hospital

    Shanghai, Shanghai Municipality

    De-jie Chu, MD

    De-jie Chu, MD

    Recruiting
  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

    Min Zhang, MD

    Min Zhang, MD

    Recruiting
  • Shanghai Putuo District People's Hospital

    Shanghai, Shanghai Municipality

    Feng-ying Zhang, MD

    Feng-ying Zhang, MD

    Recruiting
  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality

    Tao Ren, MD

    Tao Ren, MD

    Recruiting
  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality

    Yuan-lin Song, MD

    Yuan-lin Song, MD

    Recruiting
  • Shangrao People's Hospital

    Shangrao, Jiangxi

    Qing-wei Meng, MD

    Qing-wei Meng, MD

    Recruiting
  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning

    Yu Chen, MD

    Yu Chen, MD

    Recruiting
  • The First Affiliated Hospital of China Medical University

    Shenyang, Liaoning

    Wei Wang, MD

    Wei Wang, MD

    Recruiting
  • Shenzhen Institute of Respiratory Diseases

    Shenzhen, Guangdong

    Ling-wei Wang, MD

    Ling-wei Wang, MD

    Recruiting
  • The Eighth Affiliated Hospital of Sun Yat-Sen University

    Shenzhen, Guangdong

    Jian-quan Zhang, MD

    Jian-quan Zhang, MD

    Recruiting
  • Suzhou Science and Technology Town Hospital

    Suzhou, Jiangsu

    Chao Yang, MD

    Chao Yang, MD

    Recruiting
  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Jian-an Huang, MD

    Jian-an Huang, MD

    Recruiting
  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

    Active, not recruiting
  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Yu-ping Li, MD

    Yu-ping Li, MD

    Recruiting
  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Min Xie, MD

    Min Xie, MD

    Recruiting
  • Union Hospital,Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei

    Yang Jin, MD

    Yang Jin, MD

    Recruiting
  • Subei People's Hospital

    Yangzhou, Jiangsu

    Xing-xiang Xu, MD

    Xing-xiang Xu

    Recruiting
  • Affiliated Hospital, Guangdong Medical College

    Zhanjiang, Guangdong

    Active, not recruiting
  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Xiao-ju Zhang, MD

    Xiao-ju Zhang, MD

    Recruiting
  • Zhengzhou People's Hospital

    Zhengzhou, Henan

    Jin-guang Jia, MD

    Jin-guang Jia, MD

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
No Intervention: Observational Cohort
Keywords
bronchiectasis, Pseudomonas Aeruginosa, Eradication, Long-term impact, Observational study
Medical subject headings
Bronchiectasis, Pseudomonas Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No Intervention: Observational CohortOther

    Observational study, no additional intervention

Study groups in NCT06760273
Study groupRoleWhat they receive
Patients who successfully eradicate Pseudomonas aeruginosa in ERASE studyno intervention
Receives: Other: No Intervention: Observational Cohort
Patients who were not successful in eradicating Pseudomonas aeruginosa in the ERASE StudyNo intervention
Receives: Other: No Intervention: Observational Cohort

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 15 months

Secondary outcomes (16)
  1. 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

    Measured: 12 months

  2. 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

    Measured: 21 months

  3. 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

    Measured: 27 months

  4. 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

    Measured: 36 months

  5. 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.

    Measured: 36 months

  6. 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.

    Measured: 36 months

  7. 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.

    Measured: 36 months

  8. 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.

    Measured: 36 months

  9. 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.

    Measured: 36 months

  10. 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:

    1. 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.

    Measured: 36 months

  11. 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.

    Measured: 36 months

  12. Daily Symptoms Measured by the bronchiectasis exacerbation and symptom tool (BEST)

    Daily Symptoms were recorded by the bronchiectasis exacerbation and symptom tool (BEST)

    Measured: 27

  13. 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

    Measured: 36 months

  14. 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

    Measured: 36 months

  15. 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

    Measured: 36 months

  16. The cost of hospitalization during the follow-up period

    The cost of hospitalization during the whole study period

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start16 Oct 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
364 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06760273
Sponsor's protocol ID
20230329-1
Status last verified
Mar 2025
First submitted
29 Dec 2024
Last updated
1 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38296344
  • 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.

    PubMed 38410702
  • 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.

    PubMed 30545985
  • 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.

    PubMed 28889110

Questions about this trial

What is this clinical trial studying?

An observational study of Bronchiectasis Adult, run by Shanghai Pulmonary Hospital, Shanghai, China at 58 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin-Fu Xu (+8613321922898, jfxucn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 15 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06760273, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.

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