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:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-25 @ 2:29 AM
NCT ID:
NCT01874834
Eligibility Criteria:
Inclusion Criteria:
* Healthy men and women between 18 and 55 years of age
* Physical conditioning allowing intermittent, moderate exercise for 2 hours
* Normal lung function:
1. FVC \> 75 % of that predicted for gender, ethnicity, age and height.
2. FEV1 \> 75 % of that predicted for gender, ethnicity, age and height.
3. FEV1/FVC ratio \> 75 % of predicted values.
* Oxygen saturation \> 96 %.
Exclusion Criteria:
* A history of acute and chronic cardiovascular disease, chronic respiratory disease, diabetes, rheumatologic diseases, immunodeficiency state, and acute respiratory illness within 4 weeks.
* Subjects who are asthmatic or have a history of asthma.
* Allergic to chemical vapors or gases.
* Any allergic symptoms during the time of participation in the study
* Female subjects who are currently pregnant, attempting to become pregnant, or breastfeeding
* Subjects unwilling or unable to stop taking vitamin C or E or medications which may impact the results of the ozone challenge (such as, systemic steroids and beta blockers) at least 2 weeks prior to the study and for the duration of the study. Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's inclusion in the study.
* Current and past smokers within 1 year.
* Uncontrolled hypertension (\> 150 systolic, \> 90 diastolic).
* Subjects who do not understand or speak English
* Subjects unable to perform the moderately active exercise required for the study.
* Subjects with a history of skin allergies to adhesives used in securing heart rate monitor electrodes.
* Unspecified diseases or conditions, which in the judgment of the investigator might influence the responses to the exposures, will be a basis for exclusion.
* Subjects unwilling to stop taking over-the-counter pain medications such as aspirin, Advil, Aleve or other non-steroidal anti-inflammatory medications ("NSAIDS") for 48 hr prior to the exposures and post-exposure visits.
* Subjects with a marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 milliseconds (ms))
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01874834
Study Brief:
Protocol Section:
NCT01874834