NCT03185650

Evaluation of Regional Lung Deposition of Inhaled Saline Using the tPAD Device

Evaluation of Regional Lung Deposition of Inhaled Saline Using the Trans-Nasal Pulmonary Aerosol Delivery Device in Healthy, Non-Smoking Adult Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Diseases

Interventions

Type	Name	Description
DEVICE	tPAD Device	A novel, transnasal aerosol generator
DEVICE	PARI LC Star Nebulizer	Standard oral nebulizer

Timeline

• Start date: 2017-07-27
• Primary completion: 2018-07-27
• Completion: 2018-07-27
• First posted: 2017-06-14
• Last updated: 2018-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study