Lung Diseases Clinical Trial
Official title:
Evaluation of Regional Lung Deposition of Inhaled Saline Using the Trans-Nasal Pulmonary Aerosol Delivery Device in Healthy, Non-Smoking Adult Subjects
Purpose: Characterize the depositional attributes of a specialized trans-nasal aerosol
delivery device in healthy people using clinical measurements of mucociliary clearance.
Procedures (methods): 14% hypertonic saline (HS) aerosol containing the radio tracer
Tc99m-sulfur colloid will be delivered via the tPAD and compared to the well characterized
PARI LC Star nebulizer (7% HS) using planar gamma scintigraphy (i.e. particle clearance). The
fraction of sulfur colloid particles that clear over the ensuing 24 hours with each device
will indicate the fraction deposited in conducting airways.
Purpose: This is an early device characterization study to define the fraction of delivered
aerosol generated by a novel nebulizer (tPAD) that deposits in conducting airways.
Design: Open label, cross-over design, using a standard oral nebulizer (PARI LC Star) as a
comparator. The order of visits will be randomized.
Methods: Gamma scintigraphy will be performed following use of each device on separate study
visits.
Primary Outcome: Fraction of inhaled particles that clears over 24 hours.
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