NCT06242795 · University of North Carolina, Chapel Hill
Hypertonic Saline in NCFB
What this study is about
The purpose of this single treatment group$1 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Chapel Hill, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 13, 2025 · Source of record for eligibility and locations