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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: tdahl@delvehealth.com
• Phone: 952-200-6228

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.