Extended Observational Study on the Long-term Impact of Tobramycin Inhalation Solution for Pseudomonas Aeruginosa Eradication in Patients With Bronchiectasis: The ERASE II Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 364
- 试验地点
- 58
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients who participate the ERSE study
- •write the informed consent form.
排除标准
- •patients who were lost of follow up in the ERASE study
- •ineligible for inclusion at the discretion of the researcher for other reasons.
结局指标
主要结局
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.
时间窗: 15 months
The sputum culture will be performed in each group at 6, 9, 12, and 15 months after randomization
次要结局
- 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.(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.(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.(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.(36 months)
- The differences in the frequency of pulmonary exacerbations of bronchiectasis at 12, 15, 21, 27, and 36 months following randomization.(36 months)
- The differences in time to the first pulmonary exacerbation of bronchiectasis following randomization.(36 months)
- The differences in the frequency of severe pulmonary exacerbations of bronchiectasis at 12, 15, 21, 27, and 36 months following randomization.(36 months)
- The differences in time to the first severe pulmonary exacerbation of bronchiectasis following randomization.(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.(36 months)
- The changes in the SGRQ total score from baseline in each group at 12, 15, 21, 27, and 36 months following randomization.(36 months)
- The changes of Euroqual-5 Dimensions questionnaire following randomization.(36 months)
- Daily Symptoms Measured 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(36 months)
- 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(36 months)
- The cost of hospitalization during the follow-up period(36 months)
研究者
Jin-Fu Xu
Professor
Huadong Hospital