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 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT01981135
Eligibility Criteria:
Inclusion Criteria:
* 1\. Pass a physical exam performed by study physicians during the screening visit under a separate protocol.
2\. 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. 3. Oxygen saturation of \> 96 %. 4. Ability to tolerate intervals of moderate exercise.
Exclusion Criteria:
* 1\. A history of chronic illnesses such as diabetes, rheumatological diseases, immunodeficiency state, known clinically significant cardiac disease (including myocardial infarction, congestive heart failure and angina), chronic respiratory diseases such as chronic obstructive pulmonary disease, asthma and lung cancer.
2\. If the subject is pregnant, attempting to become pregnant or breastfeeding. 3. Subjects currently taking medications which may impact the results of the ozone challenge or interfere with any other medications potentially used in the study (to include systemic steroids and beta blockers). Subjects must refrain from all over the counter anti-inflammatory agents, and anti-oxidants for a period of one week prior to exposure. Medications not specifically mentioned here may be reviewed by the investigators prior to a subject's inclusion in the study.
4\. Smoking history within 2 years of the study. 5. Untreated hypertension (≥ 150 systolic, ≥ 90 diastolic). 6. Skin diseases or sensitivity precluding the use of ECG electrodes. 7. Symptom score greater than 21 (out of a possible 40-see accompanying score sheet) for total symptom score. Only one score may be equal to 3.
8\. Dementia. 9. Unspecified illness or condition which in the judgment of the investigator might increase the risk associated with inhalation challenge or exercise.
10\. Subjects who do not understand or speak English. 11. Subjects who are unable to perform moderate exercise.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01981135
Study Brief:
Protocol Section:
NCT01981135