Hypertonic Saline in NCFB

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT06242795
Phase
PHASE4
Status
Recruiting
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Conditions

  • Bronchiectasis
  • Non-cystic Fibrosis Bronchiectasis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 7% Hypertonic Saline via nebulization — DRUG
    Twice a day treatment with nebulized 7% HS for 2 weeks as part of airway clearance

Study Details

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.

Key Dates

Start date
Oct 23, 2024
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Repeatability of Mucociliary Clearance (MCC) at 60 minutes [ Time Frame: Day 1 (Visit 2) up to Day 14 +/- 3 (Visit 3) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27514
Katherine A. Despotes, MD
[email protected]
919-966-9198
[email protected]
Katherine A. Despotes, MD (PRINCIPAL_INVESTIGATOR)

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