ImmunosuppressionNCT01281995
Effects of Systemically Administered Hydrocortisone on the Immune System in Healthy Volunteers
An observational study of Immunosuppression and Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Background: Corticosteroids have been used to treat inflammation and immune system diseases for decades. However, despite their widespread use, there is little information on the specifics of how corticosteroids affect the immune system in humans. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Immunosuppression, Healthy, Healthy Subjects
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2011to 30 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer (health status confirmed by History and Physical Exam and blood work)
- Ages 18 years or older (no upper limit)
- Must be willing to allow samples to undergo genetic studies
Who cannot join
- Patients with diseases with an inflammatory or immune component
- Patients who have irregular circadian rhythms, i.e. those who are blind or work night shifts
- Patients with active infections requiring systemic antibiotic therapy
- Use of immune modifying medications, i.e. NSAIDs (such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), ketorolac (Toradol) within the past month
- Systemic fungal, viral, or mycobacterial infections
- Persons who are alcoholic or abusers of illicit substances
Show all 16Show fewer
- Abnormal fasting glucose >100mg/dL
- Female subjects may not be pregnant or lactating due to possible side effects of use of hydrocortisone in a non-benefit study
- Liver function tests (AST, ALT, total bilirubin, alkaline phosphatase) above the normal laboratory reference range
- Other contraindications to corticosteroids (i.e. gastrointestinal ulceration, Cushing s syndrome, congestive heart failure, uncontrolled hypertension, glaucoma, osteoporosis, or known hypersensitivity to corticosteroids)
- Corticosteroid use within the last six months prior to enrollment, including topical, intra-articular or intramuscular injections, or inhaled administration
- Prior use of systemically administered corticosteroids for >6 months duration
- Use of azole medications or chronic opiates
- Patients with psychiatric diagnoses or symptoms, to include hypomania, bipolar disorder, major depression, or dysthymia
- Patients with a body mass index greater than 30
- Subjects unable to comprehend the investigational nature of the study or those who are unable or unwilling to sign the consent
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Effects of Systemically Administered Hydrocortisone on the Human Immunome in Healthy Volunteers
Background:
- Corticosteroids have been used to treat inflammation and immune system diseases for decades. However, despite their widespread use, there is little information on the specifics of how corticosteroids affect the immune system in humans. The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone hydrocortisone affects the immune system in healthy volunteers, and in doing so to understand how hydrocortisone given at different doses works in treating many immune and inflammatory conditions.
Read more
Objectives:
- To evaluate the effects of hydrocortisone on the immune and inflammatory responses of healthy volunteers over the short and intermediate term (up to 28 days after administration).
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a full medical history and physical examination, and blood and urine tests. At this visit, participants will be separated into two groups, with each group scheduled to receive a different amount of hydrocortisone during the study visit.
- One week before the study visit, participants will provide a blood sample for baseline testing.
- Participants will be admitted for a 24-hour inpatient stay that will involve frequent blood draws. Between blood draws, participants will be able to work, watch TV, walk around, and so on, and will be provided with regular meals.
- Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be divided into two further sets of groups with different blood draw schedules:
- Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24 hours after the hydrocortisone infusion.
- Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours, with timing based on data from the previous groups blood test results.
- Participants will provide additional blood samples 7 and 28 days after the in-patient visit....
Read the detailed description
Corticosteroids have been in widespread therapeutic use as anti-inflammatory and immunomodulatory agents for decades, and there is a wealth of information on their immunosuppressive effects in animals and in human cells cultured in vitro. However, despite their ubiquitous clinical use, there is a paucity of information on the effects of corticosteroids administered to humans systemically, and no previous study has examined their effects on the human immunome.
Therefore the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes this protocol designed to obtain blood from healthy adult subjects at baseline, and then at various time points after administration of 250 mg and 50 mg of intravenous hydrocortisone. These samples will be used to perform a comprehensive and detailed analysis of the immune system in response to corticosteroid administration. To our knowledge, this protocol will be the first study to characterize the human cellular and molecular immune system parameters, or immunome, in healthy adult subjects after administration of corticosteroids. This information may be useful in understanding the mechanistic effects of this commonly prescribed class of medications in humans.
The primary objective is to perform laboratory studies to characterize the immune response in healthy adult volunteers after administration of moderate (250 mg) and low (50 mg) doses of the glucocorticoid hydrocortisone. Primary endpoint is the results of the research laboratory assessments. As samples will be stored indefinitely, the time frame for primary endpoint is indefinite.
- Conditions
- Immunosuppression, Healthy, Healthy Subjects
- Keywords
- Biologic Samples, Hydrocortisone, Laboratory Research Specimens, Glucocorticoids, Immune Modulation, Healthy Volunteer, HV
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of hydrocortisone on the human immune
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study start21 Jan 2011
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Angelique Biancotto, Ph.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281995
- Sponsor's protocol ID
- 110092
- Other IDs
- 11-H-0092
- Status last verified
- 30 Aug 2018
- First submitted
- 21 Jan 2011
- Last updated
- 4 Sep 2018
- Results posted
- No
Publications
HENCH PS, KENDALL EC, SLOCUMB CH, POLLEY HF. Effects of cortisone acetate and pituitary ACTH on rheumatoid arthritis, rheumatic fever and certain other conditions. Arch Intern Med (Chic). 1950 Apr;85(4):545-666. doi: 10.1001/archinte.1950.00230100002001. No abstract available.
PubMed 15411248Jaffe HL. THE INFLUENCE OF THE SUPRARENAL GLAND ON THE THYMUS : III. STIMULATION OF THE GROWTH OF THE THYMUS GLAND FOLLOWING DOUBLE SUPRARENALECTOMY IN YOUNG RATS. J Exp Med. 1924 Nov 30;40(6):753-9. doi: 10.1084/jem.40.6.753.
PubMed 19868956Ashwell JD, Lu FW, Vacchio MS. Glucocorticoids in T cell development and function*. Annu Rev Immunol. 2000;18:309-45. doi: 10.1146/annurev.immunol.18.1.309.
PubMed 10837061
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Systemically Administered Hydrocortisone on the Human Immunome in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01281995
- Acronym / sponsor ID
- 110092
- Conditions
- Immunosuppression, Healthy, Healthy Subjects
- Keywords
- Biologic Samples, Hydrocortisone, Laboratory Research Specimens, Glucocorticoids, Immune Modulation, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 21 Jan 2011
- Study completion
- 30 Aug 2018
- First posted
- 24 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
- Corticosteroids have been used to treat inflammation and immune system diseases for decades. However, despite their widespread use, there is little information on the specifics of how corticosteroids affect the immune system in humans. The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases is interested in studying how the steroid hormone hydrocortisone affects the immune system in healthy volunteers, and in doing so to understand how hydrocortisone given at different doses works in treating many immune and inflammatory conditions.
Objectives:
- To evaluate the effects of hydrocortisone on the immune and inflammatory responses of healthy volunteers over the short and intermediate term (up to 28 days after administration).
Eligibility:
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a full medical history and physical examination, and blood and urine tests. At this visit, participants will be separated into two groups, with each group scheduled to receive a different amount of hydrocortisone during the study visit.
- One week before the study visit, participants will provide a blood sample for baseline testing.
- Participants will be admitted for a 24-hour inpatient stay that will involve frequent blood draws. Between blood draws, participants will be able to work, watch TV, walk around, and so on, and will be provided with regular meals.
- Blood will be drawn 1 hour before the infusion of hydrocortisone. Participants will be divided into two further sets of groups with different blood draw schedules:
- Groups 1 (lower dose) and 2 (higher dose) will have blood draws 1, 4, 8, 12, and 24 hours after the hydrocortisone infusion.
- Groups 3 (lower dose) and 4 (higher dose) will have multiple blood draws over 24 hours, with timing based on data from the previous groups blood test results.
- Participants will provide additional blood samples 7 and 28 days after the in-patient visit....
Detailed description
Corticosteroids have been in widespread therapeutic use as anti-inflammatory and immunomodulatory agents for decades, and there is a wealth of information on their immunosuppressive effects in animals and in human cells cultured in vitro. However, despite their ubiquitous clinical use, there is a paucity of information on the effects of corticosteroids administered to humans systemically, and no previous study has examined their effects on the human immunome.
Therefore the Center for Human Immunology, Autoimmunity, and Inflammatory Diseases proposes this protocol designed to obtain blood from healthy adult subjects at baseline, and then at various time points after administration of 250 mg and 50 mg of intravenous hydrocortisone. These samples will be used to perform a comprehensive and detailed analysis of the immune system in response to corticosteroid administration. To our knowledge, this protocol will be the first study to characterize the human cellular and molecular immune system parameters, or immunome, in healthy adult subjects after administration of corticosteroids. This information may be useful in understanding the mechanistic effects of this commonly prescribed class of medications in humans.
The primary objective is to perform laboratory studies to characterize the immune response in healthy adult volunteers after administration of moderate (250 mg) and low (50 mg) doses of the glucocorticoid hydrocortisone. Primary endpoint is the results of the research laboratory assessments. As samples will be stored indefinitely, the time frame for primary endpoint is indefinite.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy volunteer (health status confirmed by History and Physical Exam and blood work)
- Ages 18 years or older (no upper limit)
- Must be willing to allow samples to undergo genetic studies
Key exclusion criteria (16 listed)
- Patients with diseases with an inflammatory or immune component
- Patients who have irregular circadian rhythms, i.e. those who are blind or work night shifts
- Patients with active infections requiring systemic antibiotic therapy
- Use of immune modifying medications, i.e. NSAIDs (such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), ketorolac (Toradol) within the past month
- Systemic fungal, viral, or mycobacterial infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Effects of hydrocortisone on the human immune
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
- Background: PubMed 15411248HENCH PS, KENDALL EC, SLOCUMB CH, POLLEY HF. Effects of cortisone acetate and pituitary ACTH on rheumatoid arthritis, rheumatic fever and certain other conditions. Arch Intern Med (Chic). 1950 Apr;85(4):545-666. doi: 10.1001/archinte.1950.00230100002001. No abstract available.
- Background: PubMed 19868956Jaffe HL. THE INFLUENCE OF THE SUPRARENAL GLAND ON THE THYMUS : III. STIMULATION OF THE GROWTH OF THE THYMUS GLAND FOLLOWING DOUBLE SUPRARENALECTOMY IN YOUNG RATS. J Exp Med. 1924 Nov 30;40(6):753-9. doi: 10.1084/jem.40.6.753.
- Background: PubMed 10837061Ashwell JD, Lu FW, Vacchio MS. Glucocorticoids in T cell development and function*. Annu Rev Immunol. 2000;18:309-45. doi: 10.1146/annurev.immunol.18.1.309.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angelique Biancotto, Ph.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression and Healthy, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of hydrocortisone on the human immune. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01281995, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.