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:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-26 @ 4:03 PM
NCT ID:
NCT01866306
Eligibility Criteria:
Inclusion Criteria:
Parts 1 and 2:
* have a Body Mass Index (BMI) between =\< 35 kg/m\^2 and \> 17 kg/m\^2
* female of childbearing potential is not pregnant and agrees to use 2 acceptable methods of birth control until 10 days after the last visit,; or female is of non-childbearing potential
* is a non-smoker, or has not smoked within prior 12 months, with a history of =\< 10 pack-years
Part 1:
Either of the following:
* healthy (may have out-of season seasonal allergies)
* mild to moderate-asthmatic with a history of spontaneous or exertional wheezing; and with all of the following for \> 4 weeks prior: daytime symptoms twice weekly or less, no activity limitation, no nocturnal symptoms, uses reliever treatment twice daily or less, with an unchanged asthma medication dose, and uses inhaled corticosteroid (ICS) at a stable dose-equivalent of =\< 500 mcg/day fluticasone propionate
Part 2:
* mild to moderate-asthmatics only with a history of spontaneous or exertional wheezing; and with all of the following for \> 4 weeks prior: daytime symptoms twice weekly or less, no activity limitation, no nocturnal symptoms, uses reliever treatment twice daily or less, with an unchanged asthma medication dose, and uses ICS at a stable dose-equivalent of =\< 500 mcg/day fluticasone propionate
* had a mild change in symptoms associated with viral syndrome, leading to temporarily increased short acting beta agonist use or increased ICS dose within the past 5 years
Exclusion Criteria:
* has a history of severe or difficult to manage allergies (e.g. food, drug, latex)
* has a history of asthma-related ventilatory failure in adolescence or adulthood
* is positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
* has significant nasal septum deviation, nasal polyps or other nasal anatomical abnormality
* shares the same household or has intimate contact with an infant, pregnant or lactating woman, or immunosuppressed individual
* has a history or current evidence of any upper or lower respiratory tract infection within 6 weeks prior to baseline assessment
* had major surgery or lost 1 unit (500 mL) of blood within prior 4 weeks
* has participated in another investigational trial within the prior 10 weeks
* is pregnant or a nursing mother
* uses excluded prescription or non-prescription medications within 2 weeks prior to initial viral challenge and throughout the trial
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01866306
Study Brief:
Protocol Section:
NCT01866306