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Hypertonic Saline in NCFB

StatusRecruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 13, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary and study completion dates: Jun 2025 to Jun 2026v5
  2. Start date changed from estimate of Oct 2024 to Oct 23, 2024v4
  3. Start date: Apr 2024 to Oct 2024 Eligibility criteria shortened, about 25 words · Secondary endpoints revised (4) · Study description expanded, about 9 wordsv3 Show 3 more changesShow less
    • Eligibility criteria shortened, about 25 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2024 to Apr 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Feb 2024 to Apr 2024
    • Site details revised
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06242795
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Cystic Fibrosis Foundation
Conditions Bronchiectasis, Non-cystic Fibrosis Bronchiectasis
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov