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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT01487005
Eligibility Criteria:
Inclusion Criteria:
* males and females of all ethnic backgrounds.
* Normal spirometry (FEV1 and FVC \>75% of predicted and FEV1/FVC \>0.65).
* Ability to complete the exposure exercise regimen chosen to induce a ventilation rate of 15 to 17 L/min/m2 without exceeding 80% of predicted maximal heart rate.
* Normal baseline 12-lead resting ECG, and absence of significant ST depression while performing the 15-minute required level of exercise targeted for the exposure period.
* Subjects must be able to avoid certain medication supplements listed for 1 week before the exposure.
Exclusion Criteria:
* Non-English speaking.
* Including, but not limited to as ascertained by the physicians: Subjects with chronic cardiovascular (such as ischemic heart disease) or respiratory (such as asthma or COPD) disease; diabetes, or other organ or system dysfunction; cerebrovascular disease; active psychiatric disorders that would interfere with the subject's ability to understand and participate in the study. Subjects who have tested positive for a disease that affects the immune system (such as HIV, lymphoma, leukemia) or current drug or alcohol abuse (defined as having more than 3 drinks per day or being unable to abstain from alcohol for 3 days).
* Subjects with atopy or allergic rhinitis will not be excluded as long as they do not require regular treatment with antihistamines or systemic steroids.
* Ever-smokers (smoked tobacco or marijuana during the last five years, or with history of \>10 pack year for tobacco or \> 1 joint year for marijuana, or living with a smoker who smokes inside the house).
* Subject having plasma cotinine level \> 3ng/mL.
* BMI \>35 or \<18 (35 is the official cut off for class 1 obesity).
* Hypertension (defined as blood pressure \>140 systolic or \>90diastolic) or on anti-hypertension medications other than diuretics.
* Pregnancy or nursing (breastfeeding).
* On the following medications: prednisone, statins, beta-blockers, anticoagulants, current hormonal therapy, tamoxifen. Subjects will not be asked to discontinue needed prescription medications for the purpose of this study. If any of these medications becomes necessary during the course of the study, the subjects will be excluded. Use of other medications will be considered on an individual basis.
* Subjects taking aspirin or PDE5 inhibitors must be willing to abstain from these medications during the week preceding each exposure.
* Occupational exposures (exposed to high levels of vapors, dust, gases, or fumes on an on-going basis)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT01487005
Study Brief:
Protocol Section:
NCT01487005