Effects of Bronchial Segmental Endotoxin Instillation in Humans (NCT02392442) | Clinical Trial Compass
By InvitationPhase 2
Effects of Bronchial Segmental Endotoxin Instillation in Humans
United States58 participantsStarted 2015-06-18
Plain-language summary
Background:
\- When bacteria enter the lungs, serious infections can occur. Researchers want to learn more about the process of inflammation in the lungs by studying lung cells and the products that they make. Lung cells are influenced by infections, smoking, and molecules made within the body. Researchers also want to learn more about one of these molecules, called microRNA (or micro ribonucleic acid).
Objective:
\- To better how the body responds to infection. Also, to understand which cells in the lung secrete microRNA and how they may influence other lung cells.
Eligibility:
\- Healthy, non-smoking adults ages 18-45.
Design:
* Participants will be screened with a medical history and physical exam. They will have blood and urine tests and an electrocardiogram.
* Participants will have blood drawn from an arm vein. They will have an intravenous catheter (small plastic tube) placed in a vein.
* All participants will have bronchoscopy with bronchoalveolar lavage. They will be numbed with medicine. A thin flexible tube will be placed through the nasal passages or the mouth into the airways of the lung.
* Some participants will have bronchoscopy with bronchoalveolar lavage (rinsing the airways with salt water) in order to obtain cells from lung. The water will then be suctioned out.
* Some participants will have two bronchoscopies; during the first procedure, endotoxin, a molecule found in bacteria is squirted into a small portion of the lung. Endotoxin is a molecule that acts like an infection but isn t one. After 6 to 48 hours, bronchoscopy with with bronchoalveolar lavage will be done to look at the lung s response to endotoxin.
* Participants heart rhythm and rate, temperature and blood oxygen level will be monitored during the procedures.
* Participants will be called the next day to see how they are feeling.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy 18 to 45 year old, nonsmoking subjects based on screening examination and laboratory tests.
. No significant active medical problems. This would include but not be limited to any cardiac disorder (e.g. arrhythmia, valvular heart disease), pulmonary disease (e.g. asthma requiring chronic medications, chronic bronchitis, emphysema), neurologic disorder (e.g.
. No concurrent medications including aspirin or non-steroidal anti-inflammatory drugs or have not taken these for at least 7 days prior to study participation.
. Previous smokers would have to have abstained from cigarettes for at least one year and have no greater than a 10-pack year smoking history. If you use a hookah, e-cigarette, or vaping more than once a week, you must abstain for at least 6 weeks prior to participating in the study.
. Females must be practicing active method of birth control or abstinence of sexual activity.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial involves directly instilling endotoxin — a substance that triggers inflammation — into the airways, so how safe is that procedure, and what risks should I be aware of before considering whether this is right for me?
2Since this is a Phase 2 study looking at miRNA signals in lung cells rather than testing a new treatment, what would my personal benefit be from participating, compared to just receiving standard care for my lung inflammation?
3The trial is enrolling by invitation only — can you tell me whether I would even qualify to be considered, and what the process looks like for being invited to participate?
4Given that the primary goal is to identify biological markers in lung cells, how many procedures or bronchoscopies would I likely need to undergo, and how would that fit into my current treatment schedule?
5Are there standard treatments for acute lung inflammation that I should try first, and would participating in this research study in any way delay or interfere with those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of cell-associated and secreted miRNA with specific types of resident and inflammatory cells in the lung.
Timeframe: 6, 24, or 48 hours after Endotoxin is instilled in the lung.
Trial details
NCT IDNCT02392442
SponsorNational Institutes of Health Clinical Center (CC)