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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03185650
• Other study ID #: 16-2124
• Status: Completed
• Phase: N/A
• Start date: July 27, 2017
• Est. completion date: July 27, 2018

Study information

• Verified date: July 2018
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 27, 2018
• Est. primary completion date: July 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• tPAD Device
A novel, transnasal aerosol generator
• PARI LC Star Nebulizer
Standard oral nebulizer

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Parion Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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