Effect of Hypertonic Saline on Mucociliary Clearance in Non-CF Bronchiectasis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
University of North Carolina at Chapel Hill
RECRUITING
Chapel Hill
Contact Information
Primary
Katherine A. Despotes, MD
katherine.despotes@unchealth.unc.edu
9199669198
Backup
Alex Nesbit
alexandria_nesbit@med.unc.edu
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2026-06
Participants
Target number of participants: 20
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Cystic Fibrosis Foundation
Leads: University of North Carolina, Chapel Hill

This content was sourced from clinicaltrials.gov