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RECRUITING

NCT06242795

PHASE4

Hypertonic Saline in NCFB

Sponsor: University of North Carolina, Chapel Hill

View on ClinicalTrials.gov

Summary

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 up to 5 study visits if completing both Aim 1 and Aim 2: 1 screening/enrollment visit, 2 baseline visits (1 baseline visit if only participating in Aim 2), 1 visit during which first dose of HS would be administered and assessed, and 1 visit after 2 weeks of treatment with HS.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-10-23

Completion Date

2026-06

Last Updated

2025-08-13

Healthy Volunteers

Conditions

Bronchiectasis Non-cystic Fibrosis Bronchiectasis

Interventions

DRUG

7% Hypertonic Saline via nebulization

Twice a day treatment with nebulized 7% HS for 2 weeks as part of airway clearance

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%, inclusive * History of prior bronchiectasis exacerbations (requiring antibiotics) * Chronic cough 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 * 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 * Chronic supplemental oxygen use at rest * 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

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States