Hypertonic Saline in NCFB
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of North Carolina, Chapel Hill
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- 7% Hypertonic Saline via nebulization
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
University of North Carolina, Chapel Hill
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
Source ClinicalTrials.gov