Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care

The study population will be drawn from patients receiving routine clinical care for chronic airway diseases at Ventura County Medical Center and UCLA. This population includes adolescents and adults with established diagnoses of Cystic Fibrosis, Non-cystic fibrosis bronchiectasis, and Chronic Obstructive Pulmonary Disease who require ongoing airway clearance therapy (ACT) as part of standard disease management.

Patients in this population are typically managed in outpatient pulmonary or specialty clinics and have longitudinal follow-up within the health system. They commonly experience chronic sputum production and utilize daily ACT in combination with inhaled therapies such as bronchodilators and mucolytics. The population represents individuals with stable, chronic disease who are capable of performing routine airway clearance treatments in both clinical and home settings.

Inclusion Criteria:

• Diagnosis of CF established by either genetic screening or positive chloride sweat test (Sweat chloride concentrations > 60mmol/L).
• Diagnosis of NCFB or COPD requiring regular use of airway clearance therapy.
• Age older than 11 years.
• History of chronic daily sputum production.
• Currently on a home therapeutic regimen that includes some form of ACT performed at least once daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.
• Stage I eligibility for the 3 subjects will require patients who have had ≥2 ACT session with the VEST® in-clinic with lung function measured pre-post therapy.
• FVC and FEV1 > 35%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 2 months).
• Evaluated at the Ventura County Medical Center 2 or more times in the preceding 12 months.
• Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject.
• Ability to understand study requirements and comply with study procedures. Individuals of all ethnicities are included.

Exclusion Criteria:

• Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
• Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
• Chronic chest pain.
• Participation in another clinical trial in the previous 30 days.
• Use of intravenous antibiotics in the 2 months preceding enrollment.
• Inability or unwillingness of the participant to give written informed consent.