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Protocol Details

Research Respiratory Tract Procedures

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

07-I-0142

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 75

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Bronchoscopy;
Bronchoalveolar Lavage;
Nasal Mucosal Biopsy;
Research Procedures;
Infection Susceptibility

Recruitment Keyword(s)

Lung Infection Susceptibility;
Healthy Volunteer;
HV

Condition(s)

Mycobacterium Infections, Atypical;
Granulomatous Disease, Chronic;
Job's Syndrome;
Influenza, Human

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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 The brush is withdrawn with some tissue adhering to it.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.

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Eligibility

HEALTHY VOLUNTEER INCLUSION CRITERIA FOR BRONCHOSCOPY PROCEDURES:

- 18 to 75 years of age

- Enrolled without regard to gender, race, or ethnicity

- NIH employees or non-employees eligible

- Able to provide proof of identity

- 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:

1. Complete blood count

2. Serum chemistries

3. HIV test and hepatitis serologies (HBsAg; HCV) if status is unknown

4. Prothrombin time, partial thromboplastin time

5. Urinalysis

6. Female subjects must have negative urine pregnancy test within 1 week of participation and continue birth control practices prior to participation

7. Chest radiograph (CXR)

8. Pulse oximetry

9. Electrocardiogram (ECG)

10. Treadmill exercise stress test (as indicated)

HEALTHY VOLUNTEER EXCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES:

- Less than 18 or greater than 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.

- 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

PATIENT INCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES

1. 18 to 75 years of age inclusive

2. Known or suspected respiratory infections or infection susceptibility

3. Enrolled without regard to gender, race, or ethnicity

4. Must be enrolled in a concurrent NIH protocol and under the care of a primary physician outside of the NIH

5. Able and willing to complete informed consent process

6. Able and willing to arrange to have another person drive them home after the procedure

7. Able and willing not to eat or drink anything for 6 hours prior and 2 hours after the procedure

8. Willing to donate blood and respiratory tract samples for storage to be used for future research

PATIENT EXCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES

1. Less than 18 or greater than 75 years old

2. History of recent/acute clinically significant pulmonary compromise.

----This will be defined by the following criteria:

a. New lung infection or change in status of chronic lung infection or significant new findings on chest x-ray or CT scan

b. Asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that required the use of oral or parenteral corticosteroids during the past two years

c. Clinically significant reactive airway disease that does not respond to bronchodilators

d. Unstable chronic lung disease such as Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis

e. History of pulmonary hypertension

f. Requirement of supplemental oxygen at rest

3. Unstable angina or uncontrolled heart failure or rhythm disturbance

4. Significant kidney or liver disease

5. Significant anemia with a hemoglobin of less than 7.5 grams/dl.

6. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with IM injections or blood draws, or use of anticoagulant medications

7. Use of platelet inhibitors including aspirin and NSAIDs within 7 days of procedure or clopidogrel (Plavix TM) within 14 days of procedure or the inability to safely stop platelet inhibitors for 7-14 days prior to procedures

8. History of allergic reaction to lidocaine, sedative medications like Valium TM or Versed TM, or narcotic medications like morphine or fentanyl

9. Pregnancy or breastfeeding

10. 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

HEALTHY VOLUNTEER INCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY:

- Greater than or equal to 2 years old

- Enrolled without regard to gender, race, or ethnicity

- NIH employees or non-employees eligible

- Able to provide proof of identity

- Able and willing to complete the informed consent process

- Willing to donate blood and respiratory tract samples for storage to be used for future research

- Stable vital signs

HEALTHY VOLUNTEER EXCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY:

- Less than 2 years old

- History of frequent colds or significant uncontrolled hay fever symptoms, recent or active upper respiratory tract infection, such as a cold or sinusitis, or chronic sinus infection or congestion

- History of turbinectomy or significant nasal pathology that would preclude obtaining mucosal scrape biopsies

- Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with IM injections or blood draws, or use of anticoagulant medications

-The use of nasal steroids in the past 6 weeks is an exclusion to protocol participation.

- 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

PATIENT INCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY

-Greater than or equal to 2 years old

-Known or suspected 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

-Willing to donate blood and respiratory tract samples for storage to be used for future research

PATIENT EXCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY:

-Less than 2 years old

-Significant uncontrolled hay fever symptoms or recent or active upper respiratory tract infection, such as a cold or sinusitis

-History of turbinectomy or significant nasal pathology that would preclude obtaining mucosal scrape biopsies

-Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions), significant bruising or bleeding difficulties with IM injections or blood draws, or use of anticoagulant medications

-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.

PATIENT INCLUSION CRITERIA FOR SPUTUM INDUCTION:

1. greater than or equal to 10 years old

2. Known or suspected infections or infection susceptibility

3. Enrolled without regard to gender, race, or ethnicity

4. Must be enrolled in a concurrent NIH protocol and under the care of a primary physician outside of the NIH

5. Able and willing to complete informed consent process

6. Willing to donate blood and respiratory tract samples for storage to be used for future research

PATIENT EXCLUSION CRITERIA FOR SPUTUM:

1. < 10 years old

2. Significant uncontrolled asthma or reactive airways disease

3. 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.


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Citations:

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. Epub 2005 Jul 14.

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.

Bush A, Pohunek P. Brush biopsy and mucosal biopsy. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 2):S18-22.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Kenneth N. Olivier, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10 RM 12C110
10 CENTER DR
BETHESDA MD 20814
(301) 496-5673
kenneth.olivier@nih.gov

Cathleen Frein, R.N.
National Heart, Lung and Blood Institute (NHLBI)
National Institutes of Health
Building 10
Room 4A-31
10 Center Drive
Bethesda, Maryland 20892
(301) 402-1006
freinc@mail.nih.gov

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

prpl@mail.cc.nih.gov

Clinical Trials Number:

NCT00471250

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