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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT01617369
Eligibility Criteria:
Inclusion Criteria:
* Healthy subjects, without respiratory or cardiac comorbidities
* Age 18-55 years, inclusive
* FEV1 \> 80% predicted and FEV1/FVC ratio \>70%
* 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
* Subjects who are capable of providing their written informed consent to participate in the study
Exclusion Criteria:
* History of smoking \> 10 pack-years
* Any history of smoking within 60 days of screening
* Acute upper or lower respiratory illness within 30 days of screening
* Respiratory medication for any indication within 30 days of screening
* History of asthma, chronic bronchitis, or other chronic lung disease
* History of intolerance to hypertonic saline
* Women who are pregnant, lactating, or of childbearing potential who are unwilling to use an acceptable method of contraception throughout the duration of the study.
* Any condition that, in the opinion of the investigator, would potentially jeopardize the safety of the participant or the integrity of the study
* History of radiation exposure within the past year that would cause the subject to exceed limits for adults established by Federal Regulations
* Subjects who, in the opinion of the Principal Investigator, should not participate in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01617369
Study Brief:
Protocol Section:
NCT01617369