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Hypertonic Saline for Non-Cystic Fibrosis Bronchiectasis

This study is looking at how 7% hypertonic saline (a salty solution) delivered by a nebulizer (a device that turns liquid medicine into a mist you can inhale) affects people with bronchiectasis (dilated airways) not caused by cystic fibrosis. Researchers want to see if this treatment helps clear mucus from the lungs. You would receive 7% hypertonic saline twice a day for two weeks. The main goal is to measure how well your lungs clear mucus at the start, after one dose, and after two weeks of treatment. To join, you must be an adult over 18 with a confirmed diagnosis of bronchiectasis involving at least two lobes, and have a history of lung infections requiring antibiotics. The study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is an open-label, single-arm pilot study, meaning all participants receive the same treatment and everyone knows what treatment is being given. It plans to enroll 20 participants.
What's involved
You would attend up to 5 study visits. These visits involve medical history review, pregnancy testing (if applicable), lung function tests, and mucus clearance scans. You would also administer 7% hypertonic saline twice daily for two weeks.
Compensation
Not stated in the trial record.
Follow-up
Your mucus clearance will be measured up to 7 weeks after the start of the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06242795

Hypertonic Saline in NCFB

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of North Carolina, Chapel Hill
~20 participants
Updated 2025-08-13 on ClinicalTrials.gov
What's tested:7% Hypertonic Saline via nebulization

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Repeatability of Mucociliary Clearance (MCC) at 60 minutes
Measured over Day 1 (Visit 2) up to Day 14 +/- 3 (Visit 3)
+1 more outcome measured

Conditions

Bronchiectasis
Non-cystic Fibrosis Bronchiectasis

Explore related trials

Non-cystic Fibrosis Bronchiectasis

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Katherine A. Despotes, MD · PRINCIPAL_INVESTIGATOR · University of North Carolina, Chapel Hill

Who to contact

Katherine A. Despotes, MD
[email protected]
9199669198
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Repeatability of Mucociliary Clearance (MCC) at 60 minutesDay 1 (Visit 2) up to Day 14 +/- 3 (Visit 3)

    The primary outcome for Aim 1 will be the correlation between the average rate of MCC measured in the whole right lung compartment over 60 minutes (MCC60), calculated using point estimates collected every 10 minutes, assessed from two separate visits (Visit 2 and 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)Day 1 (Visit 2) up to 7 weeks (Visit 5)

    Mean baseline MCC60 from Visit 2 and optional Visit 3 (if participating in Aim 1) will be compared with MCC60 measured 30 minutes after first HS dose at Visit 4, and with MCC60 measured 12 hours after last dose of HS following 2 weeks of treatment with twice a day HS at Visit 5. MCC60 will be measured as the average rate of MCC measured in the whole right lung compartment over 60 minutes, calculated using point estimates collected every 10 minutes, at Visit 2 (mean Baseline from Visit 2 and Visit 3 if completing Aim 1), Visit 4, and Visit 5.