Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS)

Официальное название

Real Life Evaluation of the LibAirty Airway Clearance System in Adults With Bronchiectasis (RELACS) - A Prospective Study

Обзор

The purpose of this study is to collect data to assess the use of the LibAirty™ System for improving bronchiectasis symptoms and healthcare resource utilization when it is used at home. The main question this study is trying to answer is: How often do adults with bronchiectasis experience pulmonary exacerbations (flare-ups of their lung condition) while using the LibAirty™ airway clearance system at home? Participants will use the LibAirty™ airway clearance system at home as prescribed by their doctor - the device is not being provided as part of the study. The study will last for 12 months from the time participants begin using LibAirty. During the study period, participants will continue with their usual clinic visits. At some of these regular visits (up to 4 times over the year), participants will be asked to complete short questionnaires about their bronchiectasis symptoms and their experience using LibAirty. At these same visits, the study team will also review participants' medical records and collect information related to their bronchiectasis condition, such as test results, medications, and any hospital or emergency room visits.

Подробное описание

This prospective, single-arm, open-label study aims to evaluate the real-world use of the LibAirty™ Airway Clearance System for airway clearance in adult patients with bronchiectasis in a home setting. The primary objective is to assess the rate of pulmonary exacerbations during the 12-month study period, compared to the 12 months prior to enrollment, using each participant as their own historical control.

Importantly, this study is observational in nature. Participants are prescribed the LibAirty™ system by their treating physician as part of routine clinical care, independent of study enrollment. The study does not assign participants to receive the device, nor does it provide the device as part of the study. Participants will use the LibAirty™ system in the same manner and frequency as they would outside of the study, based on the physician's clinical judgment and standard treatment protocols.

The study will observe clinical outcomes in participants who are already prescribed the device. Data will be collected prospectively during regularly scheduled clinic visits that occur as part of each participant's standard care. At up to four of these visits, information will be gathered from medical records, and participants will complete validated questionnaires to assess health-related quality of life and user satisfaction with the LibAirty™ system. Adherence to therapy will be assessed using usage logs recorded by the device.

Additional clinical outcomes such as hospitalizations, emergency department visits, use of antibiotics for exacerbations, pulmonary function test results, and healthcare resource utilization related to bronchiectasis will be monitored. No investigational procedures, treatments, or interventions are introduced or modified by the study team.

This study is designed to generate real-world evidence on the effectiveness, adherence, and patient experience associated with the LibAirty™ system when used as part of standard bronchiectasis care in the home setting.

Вмешательства

• Устройство Airway clearance system
  The device is prescribed as part of each participant's regular medical care, independently of the study. The study does not assign the device or alter standard treatment. Participants are observed while using the device as part of their usual care.

Первичные конечные точки

• The primary endpoint for this study is the rate of pulmonary exacerbations (PE). [Срок оценки: 12 months]

Вторичные конечные точки (10)

• Rate of respiratory related hospitalizations, including length of stay [Срок оценки: 12 months]
• Rate of severe PEs (requiring IV antibiotics and/or hospitalization) [Срок оценки: 12 months]
• Number of respiratory related ED visits [Срок оценки: 12 months]
• Change from Baseline in PFTs (FEV1) [Срок оценки: 12 months]
• Change from Baseline in PFTs (FVC) [Срок оценки: 12 months]
• Change from Baseline in PFTs (FEV1/FVC) [Срок оценки: 12 months]
• Change from baseline in Quality of Life (QoL-B) [Срок оценки: 12 months]
• User satisfaction with the LibAirty system [Срок оценки: 12 months]
• Adherence to therapy [Срок оценки: 12 months]
• Healthcare resource utilization resulting from respiratory condition [Срок оценки: 12 months]

Критерии участия

Критерии включения

• Have a radiological diagnosis of Bronchiectasis based on high resolution chest CT scan
• Have bronchiectasis characterized by either:

• Daily productive cough (as determined by a treating physician)
• OR Available documentation from the last 12 months of 2 or more pulmonary exacerbations requiring antibiotic therapy
• Be at age ≥ 21 years
• Prescribed and receives the LibAirty system for home use
• Be on a standard of care treatment plan that includes at least one physician encounter every 6 months
• No change in treatment for Bronchiectasis in the 2-month period prior to enrollment
• Signed informed consent

Критерии исключения

• Inability to independently perform therapy with the LibAirty system as directed
• Any other condition that, in the opinion of the PI, could jeopardize the safety of the subject or impact the validity of the study results.
• Pregnancy or planned pregnancy during the expected duration of the trial (12 months).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 3 центра

• University of Alabama at Birmingham — Birmingham
• Emory University School Of Medicine — Atlanta
• Medical University of South Carolina — Charleston

Идентификаторы

NCT: NCT07135284 · CL-00010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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