Study to Characterize the Durability of Hypertonic Saline to Enhance Mucociliary Clearance in Healthy Subjects
The purpose of this research study is to learn about how long hypertonic saline (HS) works in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up in the lungs. Hypertonic saline and other medications currently being developed may help patients with these lung diseases by speeding up mucus clearance from the lung. For these treatments to be effective, they likely need to be able to act for at lease several hours. Investigators are able to measure how lung treatments like hypertonic saline work by conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how long hypertonic saline works in people who do not have CF. Investigators plan to use this information to improve the design and testing of new treatments for patients with chronic bronchitis.
- The investigators will use MCC measurements to determine the durability of action of hypertonic saline in healthy (i.e. non-CF) subjects.
- The investigators will determine the intra- and inter-individual variability of baseline MCC measurements using a slow inhalation/large particle protocol in healthy subjects to guide future sample size calculations.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study to Characterize the Durability of Hypertonic Saline for the Enhancement of Mucociliary Clearance in Healthy Subjects|
- Change in mucociliary Clearance [ Time Frame: 1 and 4 hours ] [ Designated as safety issue: No ]MCC will be measured 30 min and 4 hrs after individual doses of 2.8% NaCl. The change from baseline measurements will be made to assess the pharmacodynamic response.
|Study Start Date:||June 2012|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Experimental: Hypertonic saline
Drug: Hypertonic Saline
2.8% NaCl x 4ml via nebulizer
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617369
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Scott Donaldson, MD||University of North Carolina, Chapel Hill|