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

Primary Purpose

Lung Diseases

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

tPAD Device

PARI LC Star Nebulizer

About this trial

This is an interventional device feasibility trial for Lung Diseases focused on measuring Healthy Volunteers

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects aged 18 to 65 years (inclusive), and with a body mass index (BMI) < 30 kg/m2.
Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation.
Subjects who are in good health, as determined by a medical history and examination.
Subjects who have normal lung function with a FEV1 ≥80% predicted and a FEV1/FVC >70%.
Subjects who are capable of providing written informed consent in English to participate in the study.

Exclusion Criteria:

Subjects who have evidence of an upper or lower respiratory infection or clinically significant illness at entry or within 14 days of the start of dosing.
Subjects with lung diseases as defined by a FEV1 <80% or a FEV1/FVC <70%
Subjects on inhaled medications, such as short or long acting bronchodilators or inhaled corticosteroids, will be excluded.
Subjects with a history of allergy or intolerance to albuterol or hypertonic saline.
Subjects with active chronic or acute rhinosinusitis or other nasal or sinus abnormality or disease.
Subjects who have a present history of any clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological disorder or disease, substance abuse, or any other major disorder or disease.
Subjects who have had radiation exposure within the past year that would cause them to exceed Federal Regulations of 15 Rem annually by participating in this study. The study team will determine this.
Subjects with a history of smoking within the last 3 months.
Subjects with a positive pregnancy test or who are pregnant or are nursing.
Subjects who, in the opinion of the Principal Investigator, should not participate in the study.
Subjects with a BMI >30 kg/m2
Subjects who are taller than Height >6'2"
Subjects who have facial hair that they are not willing to shave

Sites / Locations

University of North Carolina at Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

tPAD, then PARI LC Star Nebulizer

PARI LC Star Nebulizer, then tPAD

Arm Description

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 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03185650

First Posted

June 9, 2017

Last Updated

October 2, 2018

Sponsor

University of North Carolina, Chapel Hill

Collaborators

Parion Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03185650

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

July 27, 2017 (Actual)

Primary Completion Date

July 27, 2018 (Actual)

Study Completion Date

July 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

Parion Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases

Keywords

Healthy Volunteers

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Healthy subjects will use each nebulizer device in random order at separate study visits.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

tPAD, then PARI LC Star Nebulizer

Arm Type

Other

Arm Description

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.

Arm Title

PARI LC Star Nebulizer, then tPAD

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

tPAD Device

Intervention Description

A novel, transnasal aerosol generator

Intervention Type

Device

Intervention Name(s)

PARI LC Star Nebulizer

Intervention Description

Standard oral nebulizer

Primary Outcome Measure Information:

Title

24-hour clearance fraction

Description

The percentage of initially deposited aerosol particles that clear over 24 hours will be measured with gamma scintigraphy after 24 hours

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Central:Peripheral Deposition Ratio

Description

The ratio of labelled particles initially deposited in the central and peripheral lung zones will be assessed to characterize aerosol targeting of the lung

Time Frame

0-4 minutes after deposition

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects aged 18 to 65 years (inclusive), and with a body mass index (BMI) < 30 kg/m2. Non-pregnant female subjects must be either not sexually active, post-menopausal, surgically sterilized, or agree to use an appropriate "double-barrier" method (such as a diaphragm and condom); or, must currently be using a prescribed transdermal, injection, implant, or oral contraceptive during study participation. Subjects who are in good health, as determined by a medical history and examination. Subjects who have normal lung function with a FEV1 ≥80% predicted and a FEV1/FVC >70%. Subjects who are capable of providing written informed consent in English to participate in the study. Exclusion Criteria: Subjects who have evidence of an upper or lower respiratory infection or clinically significant illness at entry or within 14 days of the start of dosing. Subjects with lung diseases as defined by a FEV1 <80% or a FEV1/FVC <70% Subjects on inhaled medications, such as short or long acting bronchodilators or inhaled corticosteroids, will be excluded. Subjects with a history of allergy or intolerance to albuterol or hypertonic saline. Subjects with active chronic or acute rhinosinusitis or other nasal or sinus abnormality or disease. Subjects who have a present history of any clinically significant neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological disorder or disease, substance abuse, or any other major disorder or disease. Subjects who have had radiation exposure within the past year that would cause them to exceed Federal Regulations of 15 Rem annually by participating in this study. The study team will determine this. Subjects with a history of smoking within the last 3 months. Subjects with a positive pregnancy test or who are pregnant or are nursing. Subjects who, in the opinion of the Principal Investigator, should not participate in the study. Subjects with a BMI >30 kg/m2 Subjects who are taller than Height >6'2" Subjects who have facial hair that they are not willing to shave

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott Donaldson, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of North Carolina at Chapel Hill

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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

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