RECRUITINGINTERVENTIONAL

OLE Therapy With BE Patients in Home Care Study

Oscillating Lung Expansion (OLE) Therapy in the Bronchiectasis Patients (BE) Home Care Study Protocol

About This Trial

The study will examine how the performance of Oscillating Lung Expansion (OLE) therapy affects the respiratory health of patients with Bronchiectasis (BE). The patient will use the BiWaze Clear system for their airway clearance therapy, instead of their previously prescribed therapy. BiWaze Clear is an FDA-cleared respiratory therapy for assisting patients in loosening and mobilizing secretions as well as treating and preventing atelectasis by providing lung expansion and high-frequency oscillation therapies, combined with aerosol delivery. The patient will perform airway clearance with BiWaze Clear as prescribed. The system uses a disposable breathing circuit, which is a single patient use, disposable circuit. The treatment duration is 6 months . The BiWaze Clear System is indicated for the mobilization of secretions, lung expansion therapy, the treatment and prevention of pulmonary atelectasis and has the ability to provide supplemental oxygen when used with an oxygen supply.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form (and Child assent if minor subject). Who Should NOT Join This Trial: 1. Diagnosis with rapidly progressing NMD. 2. Post bronchodilator FEV₁ ≥ 65 % predicted 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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 Child assent if minor subject). Exclusion Criteria: 1. Diagnosis with rapidly progressing NMD. 2. Post bronchodilator FEV₁ ≥ 65 % predicted 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.

Treatments Being Tested

DEVICE

BiWaze Clear System

The BiWaze Clear device includes several components as follows: 1. BiWaze Clear System. 2. BiWaze Clear Dual Lumen Breathing Circuit. * Dual Lumen bacterial/viral filter. * Dual Lumen breathing tube. * Patient Interface (Anesthesia mask \[small, medium or large\], Mouthpiece, or trach adapter). 3. Carrying Bag. The patient will perform airway clearance therapy with the BiWaze Clear System

Locations (4)

Central Florida Pulmonary Group, P.A.

Orlando, Florida, United States

Treasure Coast Medical Research Group, LLC

Port Saint Lucie, Florida, United States

Metropolitan Clinical Research

Tamarac, Florida, United States

University of South Florida -Tampa General Hospital

Tampa, Florida, United States