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
NCT number | NCT03185650 |
Other study ID # | 16-2124 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 27, 2017 |
Est. completion date | July 27, 2018 |
Verified date | July 2018 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Parion Sciences |
United States,
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 |
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