Actively Recruiting
Hypertonic Saline in NCFB
Led by University of North Carolina, Chapel Hill · Updated on 2025-08-13
20
Participants Needed
1
Research Sites
83 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
C
Cystic Fibrosis Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Hypertonic Saline in NCFB
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults >18 years of age able to provide informed consent
- Diagnosis of bronchiectasis confirmed on prior chest CT involving at least 2 lobes, with at least one lobe in the right lung
- Forced expiratory volume in one second (FEV1) percentage predicted greater than or equal to 40%
- History of prior bronchiectasis exacerbations requiring antibiotics
- Chronic cough
You will not qualify if you...
- Diagnosis of cystic fibrosis, primary ciliary dyskinesia, chronic aspiration, or traction bronchiectasis due to interstitial lung disease
- Unable or unwilling to complete a 2-week washout period from hypertonic saline before the first baseline MCC scan
- Use of inhaled acetylcysteine or dornase alfa
- Pulmonary exacerbation within the past 4 weeks
- History of intolerance to hypertonic saline such as bronchospasm or hemoptysis
- Significant hemoptysis (>60 ml) within the past 3 months
- Chronic supplemental oxygen use at rest
- Severe asthma requiring chronic oral corticosteroids (>10 mg/day), biologic therapies, recent hospitalization for status asthmaticus, or bronchiectasis caused by chronic asthma
- Significant bronchodilator response (>15% increase in FEV1 or FVC) during screening spirometry
- Failed hypertonic saline tolerability test at screening due to intolerable symptoms or lung function decline
- Smoking, vaping, or substance use in the past year, or more than 10 pack-years of cigarette smoking lifetime
- More than 2 chest CT scans in the past year or lung radiation exposure over 150 millisieverts
- Current or recent participation in other interventional studies for non-CF bronchiectasis
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
Research Team
K
Katherine A. Despotes, MD
CONTACT
A
Alex Nesbit
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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