Collection of Lung Fluid and Tissue Samples for Research

NCT00471250 | Recruiting

• 2 other identifiers: 07014207-H-0142
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

This study will collect fluid and tissue specimens from the lungs and nose of healthy people and people with a history of lung infections. The specimens will be examined for differences between the two groups that may be associated with susceptibility to certain infections. Healthy normal volunteers and people with a history of lung infections between 18 and 75 years of age who are followed at NIH may be eligible for this study. Participants undergo the following procedures: Medical history and physical examination. Blood and urine tests. Electrocardiogram (ECG) and chest x-ray. Treadmill exercise stress test (for people over 45 years old with a history of chest pain or ECG abnormalities). Bronchoscopy: The subject s nose and throat are numbed with lidocaine and a sedative is given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways carefully. Fluid collection during the bronchoscopy using one of the following methods:

• Bronchoalveolar lavage: Salt water is injected through the bronchoscope into the lung and immediately suctioned out, washing off cells lining the airways.
• Bronchial brushings: A brush-tipped wire enclosed in a sheath is passed through the bronchoscope and a small area of the airway tissue is gently brushed. The brush is withdrawn with some tissue adhering to it.
• Endobronchial biopsies: Small pinchers on a wire are passed through the bronchoscope and about 1 to 2 millimeters of tissue is removed.
• Nasal scrape: A small device is used to scrape along the inside of the nose to collect some cells.
• Sputum induction
• Exhaled breath condensate to obtain specimens for in vitro investigations and comparisons of both the cellular and acellular components.
• Nasal nitric oxide production
• Nasal potential difference
• Exhaled aerosol mask sample collection
• Cough aerosol collection
• Exhaled particle collection
• Lung Clearance Index (LCI)

Conditions

Leukocyte Disorders; Respiratory Tract Diseases; Bronchoscopy

Keywords

Lung Infection Susceptibility; Bronchoalvealar lavage; Nasal Biopsy; Sputum Sample; Infection Susceptibility; Natural History; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• obtain bronchoalveolar lavage fluid, sputum, and/or airway epithelial cells from healthy volunteers and from patients who acquire respiratory infections, to look for differences in immune function between these groups, and to discover new pat...

  to obtain respiratory tract cells fluids, and bedside physiologic measurements from normal and diseased subjects to support current bench research studies or to be stored for future studies.

  10 years

Study Arms (2)

1

Healthy Volunteers

2

NIH patients with known or suspected susceptibility to infection.

Eligibility Criteria

• Age: 5 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers and NIH patients with known or suspected susceptibility to infection.@@@@@@

You may qualify if:

• to 75 years of age inclusive
• Enrolled without regard to gender, race, or ethnicity
• NIH staff are eligible
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Able and willing to complete the informed consent process
• Able and willing to arrange to have another person drive them home after the procedure
• Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the procedure
• Willing to donate blood and respiratory tract samples for storage to be used for future research
• In good general health without clinically significant medical history
• Physical examination without clinically significant findings
• Screening laboratory tests without clinically significant abnormalities:
• Complete blood count with differential
• Serum chemistries including creatinine, blood urea nitrogen, glucose, liver enzymes and function tests, electrolytes
• HIV test and hepatitis serologies (HBsAg; HCV) if status is unknown
• Prothrombin time, partial thromboplastin time

You may not qualify if:

• \<18 or \>75 years old
• A smoking history of 10 pack-years or more, a current smoker, or tobacco free for less than a year.
• Positive HIV status. Subjects must have a negative FDA-approved HIV blood test. \[Note: Results of HIV enzyme-linked immunosorbent assay (ELISA) will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study\]
• Acute or chronic hepatitis based on viral hepatitis serologies
• Pregnancy or breastfeeding
• Any active medical problems especially bleeding disorders, significant bruising or bleeding difficulties with intramuscular (IM) injections or blood draws, use of anticoagulants, or pulmonary disorders including asthma
• History of allergic reaction to lidocaine, sedative medications like Valium Trademark or Versed Trademark, or narcotic medications like morphine or fentanyl
• Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past three months. (Note that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics is not excluded).
• Use of platelet inhibitors including aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days of procedure
• Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer s ability to give informed consent
• to 75 years of age inclusive
• Known or suspected respiratory infections or infection susceptibility
• Enrolled without regard to gender, race, or ethnicity
• Must be enrolled in a concurrent NIH protocol and under the care of a primary physician outside of the NIH
• Able and willing to complete informed consent process

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

• Busse WW, Wanner A, Adams K, Reynolds HY, Castro M, Chowdhury B, Kraft M, Levine RJ, Peters SP, Sullivan EJ. Investigative bronchoprovocation and bronchoscopy in airway diseases. Am J Respir Crit Care Med. 2005 Oct 1;172(7):807-16. doi: 10.1164/rccm.200407-966WS. Epub 2005 Jul 14.

  PMID: 16020805 BACKGROUND

• Goldstein RA, Rohatgi PK, Bergofsky EH, Block ER, Daniele RP, Dantzker DR, Davis GS, Hunninghake GW, King TE Jr, Metzger WJ, et al. Clinical role of bronchoalveolar lavage in adults with pulmonary disease. Am Rev Respir Dis. 1990 Aug;142(2):481-6. doi: 10.1164/ajrccm/142.2.481.

  PMID: 2200319 BACKGROUND

• Bush A, Pohunek P. Brush biopsy and mucosal biopsy. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 2):S18-22. doi: 10.1164/ajrccm.162.supplement_1.maic-5. No abstract available.

  PMID: 10934126 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Leukocyte Disorders; Respiratory Tract Diseases

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Andrew J Lipton, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chevalia J Robinson, R.N.

CONTACT

(301) 496-3973; robinsoc1@nih.gov

Andrew J Lipton, M.D.

CONTACT

(301) 451-4950; andrew.lipton@nih.gov

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 9, 2007
• Study Start: August 17, 2007
• Last Updated: May 7, 2026

Record last verified: 2025-12-18

Locations

US (1)