Home OLE (oscillating lung expansion) therapy with BiWaze Clear for bronchiectasis

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

This study will see if using the BiWaze Clear home therapy for six months helps people with bronchiectasis have fewer pulmonary exacerbations.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 85 (estimated)
• Ages: 5 Years and up
• Sex: All
• Sponsor: Delve Health (Academic / other)
• Locations: 5 sites (New Haven, Connecticut and 4 other locations)
• Trial ID: NCT06926881 on ClinicalTrials.gov

What this trial studies

This interventional, open‑label study asks 85 participants aged 5 and older with bronchiectasis to use the FDA‑cleared BiWaze Clear system at home for six months. Participants will perform prescribed airway‑clearance sessions using a single‑patient disposable circuit and may use supplemental oxygen if needed. The primary outcome is the frequency of pulmonary exacerbations during the six months on BiWaze Clear compared with the number recorded in the 12 months before starting therapy, plus other clinical outcomes. Sites in Connecticut and Florida will enroll both adult and pediatric patients meeting the inclusion and exclusion criteria.

Who should consider this trial

Good fit: People aged 5 years and older with a diagnosis of bronchiectasis who are clinically stable, can perform the therapy as prescribed, and have had at least one exacerbation in the past 6 months (or two in the past 12 months).

Not a fit: Patients with rapidly progressing neuromuscular disease, recent pneumothorax, anticipated hospitalization within six months, or recent use of OLE therapy are excluded and may not receive benefit from this protocol.

Why it matters

Potential benefit: If successful, regular home use of BiWaze Clear could reduce pulmonary exacerbations and improve breathing and quality of life for people with bronchiectasis.

How similar studies have performed: Other oscillatory and airway‑clearance devices have shown mixed but often favorable results for secretion clearance, though direct evidence specifically proving BiWaze Clear reduces bronchiectasis exacerbations is limited.

Eligibility criteria

Inclusion Criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Patients aged \> 5 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. Clinically stable respiratory status at the time of screening.
5. Bronchiectasis diagnosis (including patients with cystic fibrosis with documented bronchiectasis).
6. Signed informed consent (and Child assent if minor subject).

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participating in this study:

1. Diagnosis with rapidly progressing NMD.
2. Anticipated requirement for hospitalization within the next six months.
3. History of pneumothorax within the past 6 months.
4. Use of OLE therapy within the past 12 months.
5. Inability or unwillingness to perform OLE therapy or study procedures as required.
6. Currently enrolled in a different study.
7. Current smoker or tobacco use within the last 30 days.
8. Pregnancy or Breastfeeding.
9. 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.
10. Inability to comply with the treatment protocol or study procedures.
11. Known allergies to materials used in OLE device.

Where this trial is running

New Haven, Connecticut and 4 other locations

• Yale School of Medicine — New Haven, Connecticut, United States (Recruiting)
• Central Florida Pulmonary Group, P.A. — Orlando, Florida, United States (Recruiting)
• Treasure Coast Medical Research Group, LLC — Port Saint Lucie, Florida, United States (Recruiting)
• Metropolitan Clinical Research — Tamarac, Florida, United States (Recruiting)
• University of South Florida -Tampa General Hospital — Tampa, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Theresa Dahl, Master Clinical Pathology

Conditions Bronchiectasis; Pulmonary Exacerbation