NCT01143480 Study of the Effect of Innate on the Inflammatory Response to Endotoxin
| NCT ID | NCT01143480 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Environmental Health Sciences (NIEHS) |
| Condition | Asthma |
| Study Type | OBSERVATIONAL |
| Enrollment | 725 participants |
| Start Date | 2012-07-30 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 725 participants in total. It began in 2012-07-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: \- Innate immunity is the process by which white blood cells and other parts of the immune system sense and respond to potential infections by causing an inflammation. Researchers are interested in studying how the body responds to certain environmental factors, and whether the body s response can contribute to chronic illnesses or diseases such as asthma and certain types of cancers. Objectives: \- To examine how specific genes and proteins in blood cells respond to environmental exposures. Eligibility: \- Healthy volunteers between 18 and 45 years of age. Design: * The study will involve one visit of 45 to 60 minutes. * Participants will be screened with a brief physical examination and finger stick to determine if they are eligible to donate blood for the study, and will complete a questionnaire about any medications or other drugs (e.g., cigarettes) they may be taking. * Participants will provide a blood sample for research purposes.
Eligibility Criteria
* INCLUSION CRITERIA: * Male or female 18 years of age or older * Participants must be able to understand and provide written informed consent to participate in the study * Participants must be able to travel to the CRU * Willing and able to fast after midnight the night prior to their study appointment. * Healthy participants as defined by the International Red Cross guidelines (Healthy means that an individual feels well and can perform normal activities. If the individual has a chronic condition such as diabetes or high blood pressure, healthy also means that they are being treated and the condition is under control). EXCLUSION CRITERIA: * Use of nonsteroidal anti-inflammatory drugs (NSAIDs) within 5 days prior to enrollment visit (e.g., Motrin, ibuprofen, naproxen, and Advil) * Use of acetaminophen (Tylenol) within 5 days prior to enrollment visit * Use of cholesterol lowering drugs (statins) within 30 days prior to enrollment visit (e.g., Zocor, Mevacor, Lipitor, and Crestor) * Use of immunosuppressants or other immune-modifying drugs \[e.g., Rituxan, Humira, Enbrel, Cyclosporin (Neoral, Sandimmune, and SangCya), and Azathioprine (Imuran)\], Monoclonal antibodies \[e.g., infliximab (Remicade)\], and corticosteroids (e.g., prednisone, prednisolone and dexamethasone) * Current treatment for cancer with chemotherapy or radiation * Confirmed or suspected immunosuppressive or immunodeficient condition * GI or respiratory Illness within 5 days prior to enrollment visit, including cold or allergies * Smoked tobacco, chewed tobacco or used electronic cigarettes within 2 weeks prior to enrollment visit (for participants who provide a urine specimen, this will be defined by urine cotinine \>200 ng/mL at visit) * Alcohol consumption greater than 2 standard drinks (1 standard drink contains 15 g of ethanol) per day within the last 24 hours prior to the enrollment visit * Body weight \< 50 kg (\<110 lbs) * Temperature \> 37.6 C; blood pressure \< 90/50 mm Hg or \> 170/95 mm Hg; pulse rate \< 50 or \>100 beats/minute * Pregnant or suspected pregnancy * Chronic Kidney Disease The PI may review medication use on a case by case basis and make a medical determination on the participant s eligibility. In these cases, the PI determination will be documented in the participant s chart.
Contact & Investigator
Michael B Fessler, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Environmental Health Sciences (NIEHS)
Frequently Asked Questions
Who can join the NCT01143480 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01143480 currently recruiting?
Yes, NCT01143480 is actively recruiting participants. Contact the research team at myniehs@nih.gov for enrollment information.
Where is the NCT01143480 trial being conducted?
This trial is being conducted at Research Triangle Park, United States.
Who is sponsoring the NCT01143480 clinical trial?
NCT01143480 is sponsored by National Institute of Environmental Health Sciences (NIEHS). The principal investigator is Michael B Fessler, M.D. at National Institute of Environmental Health Sciences (NIEHS). The trial plans to enroll 725 participants.
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