Trial Parameters
Brief Summary
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.
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 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 c