Effect of Hypertonic Saline on Mucociliary Clearance in Non-CF Bronchiectasis

23-0185

The purpose of this single arm clinical trial is to evaluate the effects of 7% hypertonic saline (HS) delivered by nebulizer on clearance of mucus from the lungs in people with bronchiectasis (dilated airways) not due to cystic fibrosis. Mucociliary clearance (MCC) to measure the rate at which a person's lungs can clear inhaled particles will be assessed at baseline, and after acute (single dose) HS treatment, as well as after two weeks of treatment with HS. The study has two main questions: 1. Evaluate the repeatability MCC measures in people with non-CF bronchiectasis 2. Compare MCC at baseline (before treatment with HS), after a single dose of HS (acute effect of HS), and after two weeks of treatment with HS twice a day (sustained effect of HS). Participants will participate in 5 study visits: 1 screening/enrollment visit, 2 baseline visits, 1 visit during which first dose of HS would be administered and assessed, and 1 visit after 2 weeks of treatment with HS.

2024-04-01

2025-06-01

2025-06-01

Recruiting

Early phase I

20

Inclusion Criteria: * Adults \>18 years of age able to provide informed consent * Diagnosis of bronchiectasis confirmed on prior chest computed tomography (CT), involving at least 2 lobes, with at least one lobe of involvement in the right lung * Forced expiratory volume in one second (FEV1) % predicted: 40-90%, inclusive * History of prior bronchiectasis exacerbations (requiring antibiotics once in prior year) * Chronic sputum production, with subject reporting at least 1 teaspoon per day, on at least 5 days per week when at baseline Exclusion Criteria * Diagnosis of cystic fibrosis (CF), primary ciliary dyskinesia (PCD), chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD) * Unable or unwilling to undergo HS washout period of 2 weeks preceding first baseline MCC scan * Concomitant inhaled acetylcysteine or dornase alfa use * Non-tuberculous mycobacterial infection (NTM) on NTM-directed antibiotic treatment * Recent pulmonary exacerbation in preceding 4 weeks * History of intolerance to HS (bronchospasm, hemoptysis) * History of significant hemoptysis (\>60 ml) within the preceding 3 months * Severe asthma, as reflected by need for chronic oral corticosteroids (\>10mg/day), asthma biologic therapies, hospitalization for status asthmaticus within the past year, or bronchiectasis felt to have resulted from chronic asthma * Significant bronchodilator response (\>15% increase in FEV1 or forced vital capacity \[FVC\]) on pre-post spirometry testing during screening visit * Failed HS tolerability test (HSTT) at screening, as indicated by: * Intolerable symptoms after HS administration * Decline in FEV1 % predicted by \>20% when measured 15 min after HS administration * Decline in FEV1 % predicted between 10-20% when measured at 15 min that does not recover to within 10% of baseline without intervention 1 hour post HS test dose * Smoking/vaping, any substance within the past year, or \>10 pack-years of cigarette use over their lifetime * More than 2 chest CTs in the past year or a combination of procedures believed to have exposed the lungs to \>150 millisieverts (mSv) * Current/recent participation in other interventional studies for NCFB, allowing for appropriate wash-out time * Pregnancy

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This will be an open label, single arm pilot study of 7% hypertonic saline (HS) in patients with non-cystic fibrosis bronchiectasis (NCFB).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-04-12