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NCT Number: NCT06760273

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

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.

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Key information

Conditions

Bronchiectasis Adult Bacterial Infections Bacterial Infections and Mycoses Bronchial Diseases Bronchiectasis Gram-Negative Bacterial Infections Infections Pseudomonas Infections Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anhui Chest Hospital, Hefei, Anhui, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Intervention: Observational Cohort

Other

Observational study, no additional intervention

Primary outcomes

  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.

    Time frame: 15 months

    The sputum culture will be performed in each group at 6, 9, 12, and 15 months after randomization

Secondary outcomes

  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.

    Time frame: 12 months

    The sputum culture will be performed in each group at 6, 9, and 12 months after randomization

  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.

    Time frame: 21 months

    The sputum culture will be performed in each group at 6, 9, 12, 15 and 21 months after randomization

  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.

    Time frame: 27 months

    The sputum culture will be performed in each group at 6, 9, 12, 15, 21 and 27 months after randomization

  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.

    Time frame: 36 months

    The sputum culture will be performed in each group at 6, 9, 12, 15, 21, 27 and 36 months after randomization

  5. 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 occurrences of pulmonary exacerbations will be documented during the follow-up period.

  6. The differences in time to the first pulmonary exacerbation of bronchiectasis following randomization.

    Time frame: 36 months

    The occurrences of pulmonary exacerbations will be documented during the follow-up period.

  7. 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 occurrences of severe pulmonary exacerbations, defined as those requiring hospitalization, will be recorded during the follow-up period.

  8. The differences in time to the first severe pulmonary exacerbation of bronchiectasis following randomization.

    Time frame: 36 months

    The occurrences of severe pulmonary exacerbations, defined as those requiring hospitalization, will be recorded during the follow-up period.

  9. 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 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.

  10. 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 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.

  11. The changes of Euroqual-5 Dimensions questionnaire following randomization.

    Time frame: 36 months

    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.

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

    Time frame: 27

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

  13. 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 expiratory volume in 1 second [FEV1] at 12, 21, 27 and 36 months compared with baseline

  14. Changes in forced vital capacity [FVC] 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

  15. 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

    Changes in forced expiratory flow at 25-75% of forced vital capacity at 12, 21, 27 and 36 months compared with baseline

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

    Time frame: 36 months

    The cost of hospitalization during the whole study period

Study contacts

Contact information is provided by the study sponsor or research team.

Jin-Fu Xu

CONTACT

[email protected]

+8613321922898

Jin-Fu Xu, PhD

CONTACT

[email protected]

+8613321922898

Sponsors and collaborators

Lead sponsor

Shanghai Pulmonary Hospital, Shanghai, China

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2025
Registry last updated
Apr 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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