Recruiting

Hypertonic Saline

Sponsor:

University of North Carolina, Chapel Hill

Code:

NCT06242795

Conditions

Bronchiectasis

Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

7% Hypertonic Saline via nebulization

Study Details

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.

Conditions

Bronchiectasis

Non-cystic Fibrosis Bronchiectasis

Study ID

NCT06242795

Start date

Oct 23, 2024

Status verified date

Jul, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Single arm treatment group with 7% HS

All study participants will receive 7% HS by nebulizer twice a day for two weeks as part of airway clearance.

Interventions

7% Hypertonic Saline via nebulization

Twice a day treatment with nebulized 7% HS for 2 weeks as part of airway clearance

Primary outcome measure

  • Repeatability of Mucociliary Clearance (MCC) at 60 minutes [ Time Frame: Day 1 (Visit 2) up to Day 14 +/- 3 (Visit 3) ]
  • Average change in MCC60 from baseline (Visit 2 and 3), after acute treatment with HS (Visit 4), and after two weeks of treatment with HS (Visit 5) [ Time Frame: Day 1 (Visit 2) up to 7 weeks (Visit 5) ]

Central Contacts and Locations

Central contacts

Katherine A. Despotes, MD

9199669198katherine.despotes@unchealth.unc.edu

Alex Nesbit

alexandria_nesbit@med.unc.edu

Locations

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27514

Contacts

Katherine A. Despotes, MD

919-966-9198katherine.despotes@unchealth.unc.edu

katherine.despotes@unchealth.unc.edu

Principal Investigator:

Katherine A. Despotes, MD

More Information

Sponsor

University of North Carolina, Chapel Hill

Last update posted

Aug 13, 2025

Last verified

Jul, 2025

Keywords

  • airway clearance
  • mucociliary clearance
  • hypertonic saline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of North Carolina, Chapel Hill on 2025-08-13.