BronchiectasisPhase 4NCT06242795
Hypertonic Saline in NCFB
A Phase 4 study testing 7% Hypertonic Saline via nebulization in people with Bronchiectasis and Non-cystic Fibrosis Bronchiectasis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis, Non-cystic Fibrosis Bronchiectasis
- What is being tested?
- 7% Hypertonic Saline via nebulization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Oct 2024to Jun 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alex Nesbit contact
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
Katherine A. Despotes, MD, 919-966-9198, katherine.despotes@unchealth.unc.edu
katherine.despotes@unchealth.unc.edu
About this study
Official title: Effect of Hypertonic Saline on Mucociliary Clearance in Non-CF Bronchiectasis
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:
Read more
- Evaluate the repeatability MCC measures in people with non-CF bronchiectasis
- 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.
Read the detailed description
The investigators will perform an open label, single arm pilot study of 7% HS as our treatment intervention in patients with NCFB. Participants will attend up to 5 study visits.
The first visit (V1) will be a screening visit to obtain informed consent if not already obtained, confirm that subjects meet all eligibility criteria through review of medical history and clinical records, and performance of a hypertonic saline tolerance test (HSTT). Participants meeting eligibility criteria will be enrolled in the study at that time, and subsequent study visits will be scheduled.
At each study visit, medical history will be reviewed. Pregnancy testing will be performed at all visits in participants who may become pregnant. Up to two baseline MCC scans (V2 and optional V3) will be performed under baseline conditions to assess variability, and expectorated sputum will be collected at either visit. Baseline spirometry and MBW will also be obtained at V2 and V3, and QOL-B will be assessed at V2 prior to any other study procedures that could impact their symptoms and responses.
At V4, the acute response to HS on MCC will be assessed after the first dose of HS is administered at the visit, marking the start of the two-week treatment period. Participants will be given a supply of HS to incorporate in their airway clearance regimen twice a day for two weeks (treatment period of up to 17 days, depending on exact timing of when V5 falls).
The evening prior to V5, patients will perform airway clearance and receive their final dose of HS. The following morning, they will hold airway clearance until after their study visit. At V5, they will complete post-treatment QOL-B, and Treatment Satisfaction Questionnaire for Medication (TSQM), MBW, spirometry, MCC (12 hours after last dose of HS, to assess sustained response to HS), and sputum collection.
- Conditions
- Bronchiectasis, Non-cystic Fibrosis Bronchiectasis
- Being tested
- 7% Hypertonic Saline via nebulization
- Keywords
- airway clearance, mucociliary clearance, hypertonic saline
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7% Hypertonic Saline via nebulizationDrug
Also called 7% sodium chloride
Twice a day treatment with nebulized 7% HS for 2 weeks as part of airway clearance
| Study group | Role | What they receive |
|---|---|---|
| Single arm treatment group with 7% HS | Experimental | All study participants will receive 7% HS by nebulizer twice a day for two weeks as part of airway clearance. Receives: Drug: 7% Hypertonic Saline via nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatability of Mucociliary Clearance (MCC) at 60 minutes
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)
Measured: 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)
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.
Measured: Day 1 (Visit 2) up to 7 weeks (Visit 5)
Secondary outcomes (4)
Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline (mean from visit 2 and visit 3, pre-HS treatment) to Visit 5 (post-HS treatment period)
FEV1 is measured by spirometry. On each occasion, the best of 3 trials, based on American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria. The best forced vital capacity (FVC), FEV1 and Forced expiratory flow between 25% and 75% of vital capacity (FEF25-75) (from trial with highest FVC+FEV1 sum) will be recorded (absolute value and % of predicted). Baseline measurements will occur at Visit 2 (and Visit 3 if completing Aim 1). The change in FEV1 from Baseline (either Visit 2, or mean from Visit 2 and Visit 3 if completing Aim 2) to Visit 5 will then be assessed.
Measured: Day 1 (Visit 2) up to 7 weeks (Visit 5)
Change in Quality of life for Bronchiectasis (QOL-B) Domain Scores from Visit 3 (2nd baseline visit, pre-HS treatment) to Visit 5 (post-HS treatment period)
The QOL-B Version 3.1 questionnaire is a self-administered patient reported outcome for symptom assessment and health-related quality of life in people with NCFB. It is a validated tool containing 37 items in 8 domains translated into multiple languages, with minimal important difference determined per each domain. Domains include Physical Functioning, Role Functioning, Vitality, Emotional Functioning, Social Functioning, Treatment Burden, Health Perceptions, Respiratory Symptoms. Items are on 4-point Likert scales, except for the Respiratory Symptoms domain which includes an item about sputum color, which has 6 answer choices (see separate outcome measure for sputum color). Each domain is scored separately, scores are scaled up to be in the range of 0 to 100 (higher scores correspond to better health outcomes). Participants will complete the QOL-B at baseline (Visit 2), and again post-HS treatment period (Visit 5), and changes in the domain scores will be assessed.
Measured: Day 1 (Visit 2) up to 5 weeks (Visit 5)
Change in Quality of life for Bronchiectasis (QOL-B) Respiratory Symptoms Domain Sputum Score from Visit 3 (2nd baseline visit, pre-HS treatment) to Visit 5 (post-HS treatment period)
The Respiratory Symptoms domain includes one item that assesses sputum color with 6 answer choices (unlike other items on the QOL-B which are scored on 4-point Likert scales). Answer choices include "clear" (1 point, reverse coded for scoring as 4 points), "clear to yellow" (2 points, reverse coded as 3 points), "yellowish-green" (3 points, reverse coded as 2 points), "brownish-dark" (4 points, reverse coded as 1 point), "green with traces of blood" (4 points, reverse coded as 1 point), and "don't know" (6 points, reverse coded to be not scored). The sputum score is reverse coded so that higher scores correspond to better health outcomes. Reverse coded score minimum 1, maximum 4. Participants will complete the QOL-B at baseline (Visit 2), and again post-HS treatment period (Visit 5), and changes in the domain scores will be assessed.
Measured: Day 1 (Visit 2) up to 5 weeks (Visit 5)
Change in Lung Clearance Index (LCI) as measured by Multiple Breath Washout (MBW) from Baseline (mean from Visit 2 and visit 3, pre-HS treatment) to Visit 5 (post-HS treatment period)
The LCI is the number of lung turnovers required to reduce exhaled nitrogen (N2) containing tracer gas concentration to 1/40th of its starting values. It is calculated by dividing the sum of exhaled tidal breaths (cumulative exhaled volume) by simultaneously measured functional residual capacity (FRC). LCI is able to detect abnormalities in lung function earlier than more traditional modalities such as spirometry.
Measured: Day 1 (Visit 2) up to 7 weeks (Visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start23 Oct 2024
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This will be an open label, single arm pilot study of 7% hypertonic saline (HS) in patients with non-cystic fibrosis bronchiectasis (NCFB).
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Katherine A. Despotes, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242795
- Sponsor's protocol ID
- 23-0185
- Other IDs
- 005177D123
- Status last verified
- Jul 2025
- First submitted
- 26 Jan 2024
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypertonic Saline on Mucociliary Clearance in Non-CF Bronchiectasis
- ClinicalTrials.gov ID
- NCT06242795
- Acronym / sponsor ID
- 23-0185
- Conditions
- Bronchiectasis, Non-cystic Fibrosis Bronchiectasis
- Keywords
- airway clearance, mucociliary clearance, hypertonic saline
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 5 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Evaluate the repeatability MCC measures in people with non-CF bronchiectasis
- 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.
Detailed description
The investigators will perform an open label, single arm pilot study of 7% HS as our treatment intervention in patients with NCFB. Participants will attend up to 5 study visits.
The first visit (V1) will be a screening visit to obtain informed consent if not already obtained, confirm that subjects meet all eligibility criteria through review of medical history and clinical records, and performance of a hypertonic saline tolerance test (HSTT). Participants meeting eligibility criteria will be enrolled in the study at that time, and subsequent study visits will be scheduled.
At each study visit, medical history will be reviewed. Pregnancy testing will be performed at all visits in participants who may become pregnant. Up to two baseline MCC scans (V2 and optional V3) will be performed under baseline conditions to assess variability, and expectorated sputum will be collected at either visit. Baseline spirometry and MBW will also be obtained at V2 and V3, and QOL-B will be assessed at V2 prior to any other study procedures that could impact their symptoms and responses.
At V4, the acute response to HS on MCC will be assessed after the first dose of HS is administered at the visit, marking the start of the two-week treatment period. Participants will be given a supply of HS to incorporate in their airway clearance regimen twice a day for two weeks (treatment period of up to 17 days, depending on exact timing of when V5 falls).
The evening prior to V5, patients will perform airway clearance and receive their final dose of HS. The following morning, they will hold airway clearance until after their study visit. At V5, they will complete post-treatment QOL-B, and Treatment Satisfaction Questionnaire for Medication (TSQM), MBW, spirometry, MCC (12 hours after last dose of HS, to assess sustained response to HS), and sputum collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This will be an open label, single arm pilot study of 7% hypertonic saline (HS) in patients with non-cystic fibrosis bronchiectasis (NCFB).
| Arm | Type | Receives |
|---|---|---|
| Single arm treatment group with 7% HS | Experimental | Drug: 7% Hypertonic Saline via nebulizationAll study participants will receive 7% HS by nebulizer twice a day for two weeks as part of airway clearance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 7% Hypertonic Saline via nebulizationAlso: 7% sodium chlorideTwice a day treatment with nebulized 7% HS for 2 weeks as part of airway clearance | Drug | Single arm treatment group with 7% HS |
Primary outcome
Repeatability of Mucociliary Clearance (MCC) at 60 minutes
Time frame: Day 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)
Time frame: 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.
4 secondary outcomes
Change in Forced Expiratory Volume in 1 Second (FEV1) from Baseline (mean from visit 2 and visit 3, pre-HS treatment) to Visit 5 (post-HS treatment period)
Time frame: Day 1 (Visit 2) up to 7 weeks (Visit 5)
Change in Quality of life for Bronchiectasis (QOL-B) Domain Scores from Visit 3 (2nd baseline visit, pre-HS treatment) to Visit 5 (post-HS treatment period)
Time frame: Day 1 (Visit 2) up to 5 weeks (Visit 5)
Change in Quality of life for Bronchiectasis (QOL-B) Respiratory Symptoms Domain Sputum Score from Visit 3 (2nd baseline visit, pre-HS treatment) to Visit 5 (post-HS treatment period)
Time frame: Day 1 (Visit 2) up to 5 weeks (Visit 5)
Change in Lung Clearance Index (LCI) as measured by Multiple Breath Washout (MBW) from Baseline (mean from Visit 2 and visit 3, pre-HS treatment) to Visit 5 (post-HS treatment period)
Time frame: Day 1 (Visit 2) up to 7 weeks (Visit 5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Nesbit contact
Katherine A. Despotes, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 7% Hypertonic Saline via nebulization in people with Bronchiectasis and Non-cystic Fibrosis Bronchiectasis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine A. Despotes, MD (9199669198, katherine.despotes@unchealth.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeatability of Mucociliary Clearance (MCC) at 60 minutes (time frame: Day 1 (Visit 2) up to Day 14 +/- 3 (Visit 3)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.