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

NCT ID: NCT03185650

Last Updated: 2018-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-27
• Study Completion Date: 2018-07-27

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.

Conditions

Lung Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

tPAD Device

Intervention Type: DEVICE

A novel, transnasal aerosol generator

PARI LC Star Nebulizer

Intervention Type: DEVICE

Standard oral nebulizer

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

Group Type: OTHER

tPAD Device

Intervention Type: DEVICE

A novel, transnasal aerosol generator

PARI LC Star Nebulizer

Intervention Type: DEVICE

Standard oral nebulizer

Interventions

tPAD Device

A novel, transnasal aerosol generator

Intervention Type: DEVICE

PARI LC Star Nebulizer

Standard oral nebulizer

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Parion Sciences

INDUSTRY

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Donaldson, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

16-2124

Identifier Type: -

Identifier Source: org_study_id