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

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.

• 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 36 months]
• The differences in the frequency of pulmonary exacerbations of bronchiectasis at 12, 15, 21, 27, and 36 months following randomization. [Срок оценки: 36 months]
• The differences in time to the first pulmonary exacerbation of bronchiectasis following randomization. [Срок оценки: 36 months]
• The differences in the frequency of severe pulmonary exacerbations of bronchiectasis at 12, 15, 21, 27, and 36 months following randomization. [Срок оценки: 36 months]
• The differences in time to the first severe pulmonary exacerbation of bronchiectasis following randomization. [Срок оценки: 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. [Срок оценки: 36 months]
• The changes in the SGRQ total score from baseline in each group at 12, 15, 21, 27, and 36 months following randomization. [Срок оценки: 36 months]
• The changes of Euroqual-5 Dimensions questionnaire following randomization. [Срок оценки: 36 months]
• Daily Symptoms Measured by the bronchiectasis exacerbation and symptom tool (BEST) [Срок оценки: 27]