Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT03185650
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03185650
Study Brief:
Protocol Section:
NCT03185650