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.
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.
58 sites in 1 country
China58 sites, 50 recruiting
- 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
- Active, not recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
- 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
- Active, not recruiting
Hainan General Hospital, Hainan Affiliated Hospital of Hainan Medical University
Haikou, Hainan
- 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
- Active, not recruiting
The Second Hospital of Jiaxing City
Jiaxing, Zhejiang
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
De-dong Ma, MD
De-dong Ma, MD
- Active, not 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
- 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
- Active, not recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
- 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
- Active, not recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi
- 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
- Active, not recruiting
Affiliated Hospital, Guangdong Medical College
Zhanjiang, Guangdong
- 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
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.
- Conditions
- Bronchiectasis Adult
- 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 group | Role | What they receive |
|---|---|---|
| Patients who successfully eradicate Pseudomonas aeruginosa in ERASE study | no intervention Receives: Other: No Intervention: Observational Cohort | |
| Patients who were not successful in eradicating Pseudomonas aeruginosa in the ERASE Study | No intervention Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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:
- 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
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
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
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
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
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
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.
- First posted6 Jan 2025
- Study start16 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Fu Xu, Huadong Hospital
- Investigators
- Jin-Fu Xu, PhD, Principal investigator, Huadong Hospital affiliated with Fudan University
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 38296344Gao 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 38410702Hill 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 30545985Polverino 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
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06760273
- Acronym / sponsor ID
- 20230329-1
- Conditions
- Bronchiectasis Adult
- Keywords
- bronchiectasis, Pseudomonas Aeruginosa, Eradication, Long-term impact, Observational study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 364 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 16 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who successfully eradicate Pseudomonas aeruginosa in ERASE study | – | Other: No Intervention: Observational Cohortno intervention |
| Patients who were not successful in eradicating Pseudomonas aeruginosa in the ERASE Study | – | Other: No Intervention: Observational CohortNo intervention |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have participate the ERASE study (NCT06093191)
Key inclusion criteria (2 listed)
- all patients who participate the ERSE study
- write the informed consent form.
Key exclusion criteria (2 listed)
- patients who were lost of follow up in the ERASE study
- ineligible for inclusion at the discretion of the researcher for other reasons.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Intervention: Observational CohortObservational study, no additional intervention | Other | Patients who successfully eradicate Pseudomonas aeruginosa in ERASE study, Patients who were not successful in eradicating Pseudomonas aeruginosa in the ERASE Study |
Primary outcome
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
The sputum culture will be performed in each group at 6, 9, 12, and 15 months after randomization
16 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 36 months
The differences in the frequency of pulmonary exacerbations of bronchiectasis at 12, 15, 21, 27, and 36 months following randomization.
Time frame: 36 months
The differences in time to the first pulmonary exacerbation of bronchiectasis following randomization.
Time frame: 36 months
The differences in the frequency of severe pulmonary exacerbations of bronchiectasis at 12, 15, 21, 27, and 36 months following randomization.
Time frame: 36 months
The differences in time to the first severe pulmonary exacerbation of bronchiectasis following randomization.
Time frame: 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.
Time frame: 36 months
The changes in the SGRQ total score from baseline in each group at 12, 15, 21, 27, and 36 months following randomization.
Time frame: 36 months
The changes of Euroqual-5 Dimensions questionnaire following randomization.
Time frame: 36 months
Daily Symptoms Measured by the bronchiectasis exacerbation and symptom tool (BEST)
Time frame: 27
Changes in forced expiratory volume in 1 second [FEV1] at 12, 21, 27 and 36 months compared with baseline
Time frame: 36 months
Changes in forced vital capacity [FVC] at 12, 21, 27 and 36 months compared with baseline
Time frame: 36 months
Changes in forced expiratory flow at 25-75% of forced vital capacity at 12, 21, 27 and 36 months compared with baseline
Time frame: 36 months
The cost of hospitalization during the follow-up period
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Results publication: PubMed 38296344Conceicao 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.
- Results publication: PubMed 38410702Gao 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.
- Results publication: PubMed 30545985Hill 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.
- Results publication: PubMed 28889110Polverino 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.
- An extended observational study of the ERASE studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jin-Fu Xu, PhD principal investigator
Huadong Hospital affiliated with Fudan University
58 sites in 1 country: see every site and its status.
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.