OLE Therapy With BE Patients in Home Care Study

Launched by DELVE HEALTH · Apr 8, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how a new therapy called Oscillating Lung Expansion (OLE) therapy can help improve the respiratory health of patients with bronchiectasis, a condition that affects the lungs. Participants in the study will use a device called BiWaze Clear for their airway clearance therapy, which helps to loosen and clear mucus from the lungs, making it easier to breathe. This study will last for 6 months, and the BiWaze Clear system is designed to be used at home, making it convenient for patients.

To be eligible for this trial, participants need to be between 5 and 85 years old and have had at least one serious lung issue in the past 6 months that required medical help. They should also have a diagnosis of bronchiectasis. It's important to note that some people will not be able to participate, such as those who have certain rapid health issues or are currently smoking. If you join the study, you'll receive clear instructions on how to use the BiWaze Clear device, and your progress will be monitored throughout the trial to see how well the therapy works.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged 5 to 85 years old.
• • 2. History of one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which required unplanned or unscheduled medical intervention.
• • 3. Ability to perform BiWaze Clear therapy as prescribed.
• • 4. Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis).
• • 5. Signed informed consent (and assent if minor subject).
• Exclusion Criteria:
• • 1. Diagnosis with rapidly progressing NMD.
• • 2. FEV1 over 50%.
• • 3. Anticipated requirement for hospitalization within the next six months.
• • 4. History of pneumothorax within the past 6 months.
• • 5. Use of OLE therapy within the past 12 months.
• • 6. Inability or unwillingness to perform OLE therapy or study procedures as required.
• • 7. Currently enrolled in a different study.
• • 8. Current smoker or tobacco use within the last 30 days.
• • 9. Pregnancy or Breastfeeding.
• • 10. Any medical conditions deemed by investigators to have a significant impact on the study results, e.g., active cancer, severe cardiovascular, severe progressive pulmonary disease, liver, kidney, or neurological conditions.
• • 11. Inability to comply with the treatment protocol or study procedures.
• • 12. Known allergies to materials used in OLE device.