Healthy Clinical Trial
— EndoheartOfficial title:
Effects of 20,000 EU of Clinical Center Reference Endotoxin (CCRE) Versus Placebo on Systemic and Cardiovascular Inflammatory Responses in Mild Asthmatics and Healthy Volunteers
Verified date | September 2019 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To determine the systemic inflammatory effects of inhaled endotoxin and associated alterations in cardiovascular function. Subjects will undergo an exposure to inhaled endotoxin in a crossover fashion with normal saline inhalation. Blood samples and sputum samples will be taken before and after inhalation challenge to measure markers of systemic inflammation. Cardiovascular measures, including a heart rate variability monitor, flow mediated dilation of the brachial artery and left ventricular stain will also be measured.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 17, 2019 |
Est. primary completion date | September 17, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Adult volunteers with no more than mild asthma - Age 18-50 years, inclusive, of both sexes - Demonstrate an increase in peripheral blood PMNs of 20% (compared to baseline values) following inhalation of 20,000 EU of CCRE. - Negative pregnancy test for females who are not s/p hysterectomy with oophorectomy - Normal lung function, defined as (NHanes III predicted set): 1. Forced Vital Capacity (FVC) of > 80 % of that predicted for gender, ethnicity, age and height 2. Forced Expiratory Volume in the first second of the exhale (FEV1) of > 80 % of that predicted for gender, ethnicity, age and height 3. FEV1/FVC ratio of > .75 of that predicted for gender, ethnicity, age and height - Oxygen saturation of > 93%, and blood pressure within the following limits: (Systolic between 150 - 90, Diastolic between 90-60 mm Hg) Exclusion Criteria: - Any chronic medical condition considered by the PI as a contraindication to the exposure study including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, or chronic thyroid disease. - Physician directed emergency treatment for asthma exacerbation within the preceding 3 months. - Exacerbation of asthma more than 2x/week that would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. - Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a clearly recognized viral induced asthma exacerbation) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma - Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest tightness) which would be characteristic of a person of moderate or severe persistent asthma as outlined in the current NHLBI guidelines for diagnosis and management of asthma. (Not to include prophylactic use of albuterol prior to exercise). - History of intubation for asthma - Daily use of NSAIDs, or inability to withhold NSAIDs for 4 days prior to dosing. - Use of medications that may impact the results of the study to include, but not limited to, systemic corticosteroids, beta blockers. - Cigarette smoking > 1 pack per month. - Body Mass Index >35 kg/m2. - Pregnant or breast feeding women - Subjects who are employed within the past 6 months in an occupation with high risk for endotoxin exposure, such as grain storage sites or swine containment. - Any acute, non-chronic medical condition requiring treatment, such as bronchitis, pneumonia or febrile illness within the prior 4 weeks. - Participation in studies involving new molecular entities or an experimental environmental exposure in the past 4 weeks. |
Country | Name | City | State |
---|---|---|---|
United States | EPA Human Studies Facility | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Environmental Protection Agency (EPA), RTI International, United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Left Ventricular Strain | Comparing pre and post results before and after endotoxin vs normal saline inhalations | 15 minutes and 4 hrs after inhalation | |
Primary | Change in Flow Mediated Dilation | Comparing pre and post results before and after endotoxin vs normal saline inhalations | 15 minutes and 4 hrs after inhalation | |
Secondary | Percent Change in sputum Polymorphonuclear Neutrophils (PMNs) | post differences in % change comparing saline to endotoxin | 6 hrs after inhalation | |
Secondary | Percent Change in Blood Polymorphonuclear Neutrophils (PMNs) | post differences in % change comparing saline to endotoxin | 5 hours and 30 minutes after inhalation |
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