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| Name | Class |
|---|---|
| Parion Sciences | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tPAD, then PARI LC Star Nebulizer | Other | tPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then PARI LC delivering 7% HS labeled with technetium-99m sulfur colloid particles. |
|
| PARI LC Star Nebulizer, then tPAD | Other | PARI LC delivering 7% HS labelled with technetium-99m sulfur colloid particles separated by 2-28 days and then tPAD device delivering 14% HS labelled with technetium-99m sulfur colloid particles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tPAD Device | Device | A novel, transnasal aerosol generator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour clearance fraction | The percentage of initially deposited aerosol particles that clear over 24 hours will be measured with gamma scintigraphy after 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Central:Peripheral Deposition Ratio | The ratio of labelled particles initially deposited in the central and peripheral lung zones will be assessed to characterize aerosol targeting of the lung | 0-4 minutes after deposition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Donaldson, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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Healthy subjects will use each nebulizer device in random order at separate study visits.
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| PARI LC Star Nebulizer | Device | Standard oral nebulizer |
|