| NCT ID | NCT06242795 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of North Carolina, Chapel Hill |
| Condition | Bronchiectasis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 20 participants in total. It began in 2024-10-23 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Katherine A. Despotes, MD
PRINCIPAL INVESTIGATOR
University of North Carolina, Chapel Hill
Frequently Asked Questions
Who can join the NCT06242795 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bronchiectasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06242795 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06242795 currently recruiting?
Yes, NCT06242795 is actively recruiting participants. Contact the research team at katherine.despotes@unchealth.unc.edu for enrollment information.
Where is the NCT06242795 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06242795 clinical trial?
NCT06242795 is sponsored by University of North Carolina, Chapel Hill. The principal investigator is Katherine A. Despotes, MD at University of North Carolina, Chapel Hill. The trial plans to enroll 20 participants.