Clinical trial NCT03185650: 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
Overall status: COMPLETED
Phase: NA
Conditions: Lung Diseases
Keywords: Healthy Volunteers
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Parion Sciences
First posted: 2017-06-14
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Healthy subjects will use each nebulizer device in random order at separate study visits.
Primary purpose: DEVICE_FEASIBILITY

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.

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

Primary outcomes:
measure: 24-hour clearance fraction
timeFrame: 24 hours
Secondary outcomes:
measure: Central:Peripheral Deposition Ratio
timeFrame: 0-4 minutes after deposition
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Scott Donaldson, MD
role: PRINCIPAL_INVESTIGATOR
References: