Hypertonic Saline in NCFB
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 clea
| Condition(s) | Bronchiectasis, Non-cystic Fibrosis Bronchiectasis |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Locations | Chapel Hill, North Carolina, United States |
| Start date | 2024-10-23 |
| NCT ID | NCT06242795 |
| Official listing | https://clinicaltrials.gov/study/NCT06242795 |