NCT06242795RecruitingPhase 4
Hypertonic Saline in NCFB
Effect of Hypertonic Saline on Mucociliary Clearance in Non-CF Bronchiectasis
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 26 Jan 2024
- Start date
- 23 Oct 2024
- Primary completion date
- Jun 2026
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Cystic fibrosis
- NCT number
- NCT06242795
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 20
- From 23 Oct 2024 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Unable or unwilling to undergo HS washout period of 2 weeks preceding first baseline MCC scan
- Concomitant inhaled acetylcysteine or dornase alfa use
- 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
Other illness
- Diagnosis of cystic fibrosis (CF), primary ciliary dyskinesia (PCD), chronic aspiration, or predominantly traction bronchiectasis due to interstitial lung disease (ILD)
- History of intolerance to HS (bronchospasm, hemoptysis)
- History of significant hemoptysis (\>60 ml) within the preceding 3 months
Other
- Recent pulmonary exacerbation in preceding 4 weeks
- Chronic supplemental oxygen use at rest
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill Coordinator of this site? Confirm its status | Chapel Hill | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.