Hypertonic Saline in NCFB

NCT06242795 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: 23-0185005177D123
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Evaluate the repeatability MCC measures in people with non-CF bronchiectasis
2. 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).

Conditions

Bronchiectasis; Non-cystic Fibrosis Bronchiectasis

Keywords

airway clearance; mucociliary clearance; hypertonic saline

Outcome Measures

Primary Outcomes (2)

• 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)

  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.

  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)

  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)

  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)

  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)

  Day 1 (Visit 2) up to 7 weeks (Visit 5)

Study Arms (1)

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.

Drug: 7% Hypertonic Saline via nebulization

Interventions

7% Hypertonic Saline via nebulization DRUG

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

Also known as: 7% sodium chloride

Single arm treatment group with 7% HS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Katherine A. Despotes, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine A. Despotes, MD

CONTACT

9199669198; katherine.despotes@unchealth.unc.edu

Alex Nesbit

CONTACT

alexandria_nesbit@med.unc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be an open label, single arm pilot study of 7% hypertonic saline (HS) in patients with non-cystic fibrosis bronchiectasis (NCFB).

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: October 23, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)