- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03623022
Effects of 20,000 EU of Clinical Center Reference Endotoxin (CCRE) Versus Placebo(ENDOHEART) (Endoheart)
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599
- EPA Human Studies Facility
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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):
- Forced Vital Capacity (FVC) of > 80 % of that predicted for gender, ethnicity, age and height
- Forced Expiratory Volume in the first second of the exhale (FEV1) of > 80 % of that predicted for gender, ethnicity, age and height
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endotoxin, then Normal Saline
Endotoxin challenge: Subjects will undergo inhalation of 20,000 EU CCRE. The Clinical Center Reference Endotoxin (CCRE) will be inhaled by subjects as a nebulized preparation using an ultrasonic nebulizer until the challenge solution is completely spent (generally 10 minutes). Following a washout of 2 weeks to 3 months the participant will undergo a Saline Challenge: Subjects will undergo inhalation of 0.9% sodium chloride. The Normal saline will be inhaled by subjects as a nebulized preparation using an ultrasonic nebulizer until the challenge solution is completely spent (generally 10 minutes). |
subjects will undergo an exposure to inhaled endotoxin through a nebulizer for approximately 10 minutes.
Other Names:
subjects will undergo an exposure to inhaled normal saline through a nebulizer for approximately 10 minutes
Other Names:
|
Experimental: Normal Saline, then Endotoxin
Saline Challenge: Subjects will undergo inhalation of 0.9% sodium chloride. The Normal saline will be inhaled by subjects as a nebulized preparation using an ultrasonic nebulizer until the challenge solution is completely spent (generally 10 minutes). Following a washout of 2 weeks to 3 months the participant will undergo an Endotoxin challenge: Subjects will undergo inhalation of 20,000 EU CCRE. The CCRE will be inhaled by subjects as a nebulized preparation using an ultrasonic nebulizer until the challenge solution is completely spent (generally 10 minutes). |
subjects will undergo an exposure to inhaled endotoxin through a nebulizer for approximately 10 minutes.
Other Names:
subjects will undergo an exposure to inhaled normal saline through a nebulizer for approximately 10 minutes
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Left Ventricular Strain
Time Frame: 15 minutes and 4 hrs after inhalation
|
Comparing pre and post results before and after endotoxin vs normal saline inhalations
|
15 minutes and 4 hrs after inhalation
|
Change in Flow Mediated Dilation
Time Frame: 15 minutes and 4 hrs after inhalation
|
Comparing pre and post results before and after endotoxin vs normal saline inhalations
|
15 minutes and 4 hrs after inhalation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in sputum Polymorphonuclear Neutrophils (PMNs)
Time Frame: 6 hrs after inhalation
|
post differences in % change comparing saline to endotoxin
|
6 hrs after inhalation
|
Percent Change in Blood Polymorphonuclear Neutrophils (PMNs)
Time Frame: 5 hours and 30 minutes after inhalation
|
post differences in % change comparing saline to endotoxin
|
5 hours and 30 minutes after inhalation
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 17-3351
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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