Hypertonic Saline in NCFB

Bronchiectasis Clinical Trial

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

Status Recruiting

Clinical 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. 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 5 study visits: 1 screening/enrollment visit, 2 baseline visits, 1 visit during which first dose of HS would be administered and assessed, and 1 visit after 2 weeks of treatment with HS.

Clinical Trial 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 5 study visits.

The first visit (V1) will be a screening visit to obtain informed consent, 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. Two baseline MCC scans (V2 and 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 V3 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. ;

Related Conditions & MeSH terms

• Bronchiectasis
• Non-cystic Fibrosis Bronchiectasis

• NCT number: NCT06242795
• Study type: Interventional
• Source: University of North Carolina, Chapel Hill
• Contact: Katherine A. Despotes, MD
• Phone: 9199669198
• Email: katherine.despotes@unchealth.unc.edu
• Status: Recruiting
• Phase: Phase 4
• Start date: April 2024
• Completion date: June 2025