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Protocol Details

Pulmonary Effects of Bronchial Segmental Endotoxin Instillation in Humans

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

15-CC-0091

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Clinical hold/Recruitment or enrollment suspended
Gender: Male & Female
Min Age: 18 Years
Max Age: 45 Years

Referral Letter Required

No

Population Exclusion(s)

Children

Keywords

immunophenotypes;
Bronchoalveolar Lavage;
Bronchoscopy;
Endotoxin Installation;
niRNA

Recruitment Keyword(s)

None

Condition(s)

Acute Lung Inflammation

Investigational Drug(s)

Endotoxin

Investigational Device(s)

None

Intervention(s)

Other: Saline
Biological/Vaccine: Endotoxin

Supporting Site

NIH Clinical Center

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.

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Eligibility

INCLUSION CRITERIA:

1. Healthy 18 to 45 year old, nonsmoking subjects based on screening examination and laboratory tests.

2. 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.

epilepsy), kidney disease (e.g. nephritis, nephrosis), rheumatologic disorder (e.g. inflammatory arthritis), endocrine disorder (e.g. diabetes, thyroid disease), liver disease (e.g. hepatitis), gastrointestinal disorder (e.g. inflammatory bowel disease) or infectious

disease (e.g. human immunodeficiency virus).

3. 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.

4. 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.

5. Females must be practicing active method of birth control or abstinence of sexual activity.

6. Must be willing to have samples stored

EXCLUSION CRITERIA:

1. Any serious active medical problem as defined above

2. Pregnancy and/or lactation

3. BMI >30


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Citations:

O'Grady NP, Preas HL, Pugin J, Fiuza C, Tropea M, Reda D, Banks SM, Suffredini AF. Local inflammatory responses following bronchial endotoxin instillation in humans. Am J Respir Crit Care Med. 2001 Jun;163(7):1591-8.

Janssen O, Schaumann F, Holz O, Lavae-Mokhtari B, Welker L, Winkler C, Biller H, Krug N, Hohlfeld JM. Low-dose endotoxin inhalation in healthy volunteers--a challenge model for early clinical drug development. BMC Pulm Med. 2013 Mar 28;13:19. doi: 10.1186/1471-2466-13-19.

Sandstr(SqrRoot)(Delta)m T, Bjermer L, Rylander R. Lipopolysaccharide (LPS) inhalation in healthy subjects increases neutrophils, lymphocytes and fibronectin levels in bronchoalveolar lavage fluid. Eur Respir J. 1992 Sep;5(8):992-6.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Anthony F. Suffredini, M.D.
National Institutes of Health Clinical Center (CC)
NIHBC 10 - CLINICAL CENTER BG RM 2C145
10 CENTER DR
BETHESDA MD 20892
(301) 496-9320
asuffredini@mail.nih.gov

Gloria Y. Pastor, R.N.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 3-5637
10 Center Drive
Bethesda, Maryland 20892
(301) 402-3484
gloria.pastor@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT02392442

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