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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases
• Intervention / Treatment: Device: tPAD Device; Device: PARI LC Star Nebulizer

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects aged 18 to 65 years (inclusive), and with a body mass index (BMI) < 30 kg/m2.
2. 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.
3. Subjects who are in good health, as determined by a medical history and examination.
4. Subjects who have normal lung function with a FEV1 ≥80% predicted and a FEV1/FVC >70%.
5. Subjects who are capable of providing written informed consent in English to participate in the study.

Exclusion Criteria:

1. 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.
2. Subjects with lung diseases as defined by a FEV1 <80% or a FEV1/FVC <70%
3. Subjects on inhaled medications, such as short or long acting bronchodilators or inhaled corticosteroids, will be excluded.
4. Subjects with a history of allergy or intolerance to albuterol or hypertonic saline.
5. Subjects with active chronic or acute rhinosinusitis or other nasal or sinus abnormality or disease.
6. 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.
7. 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.
8. Subjects with a history of smoking within the last 3 months.
9. Subjects with a positive pregnancy test or who are pregnant or are nursing.
10. Subjects who, in the opinion of the Principal Investigator, should not participate in the study.
11. Subjects with a BMI >30 kg/m2
12. Subjects who are taller than Height >6'2"
13. Subjects who have facial hair that they are not willing to shave

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: tPAD, then PARI LC Star Nebulizer; 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.	Device: tPAD Device; A novel, transnasal aerosol generator; Device: PARI LC Star Nebulizer; Standard oral nebulizer
Other: PARI LC Star Nebulizer, then tPAD; 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	Device: tPAD Device; A novel, transnasal aerosol generator; Device: PARI LC Star Nebulizer; Standard oral nebulizer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Parion Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2017
• Primary Completion (Actual): July 27, 2018
• Study Completion (Actual): July 27, 2018

Study Registration Dates

• First Submitted: June 9, 2017
• First Submitted That Met QC Criteria: June 9, 2017
• First Posted (Actual): June 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: 16-2124

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No