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

NCT03185650 | Completed FDA Device

• 1 other identifier: 16-2124
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Central:Peripheral Deposition Ratio

  0-4 minutes after deposition

Study Arms (2)

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.

Device: tPAD Device; Device: PARI LC Star Nebulizer

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

Device: tPAD Device; Device: PARI LC Star Nebulizer

Interventions

tPAD Device DEVICE

A novel, transnasal aerosol generator

PARI LC Star Nebulizer, then tPAD; tPAD, then PARI LC Star Nebulizer

PARI LC Star Nebulizer DEVICE

Standard oral nebulizer

PARI LC Star Nebulizer, then tPAD; tPAD, then PARI LC Star Nebulizer

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Parion Sciences: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Scott Donaldson, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 9, 2017
• First Posted: June 14, 2017
• Study Start: July 27, 2017
• Primary Completion: July 27, 2018
• Study Completion: July 27, 2018
• Last Updated: October 3, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)