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 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
HEALTHY VOLUNTEER INCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY:
- greater than or equal to 18 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
- Normal screening examination
-- Normal physical exam
-- No use of concurrent prescription medications excluding those prescribed for contraception
-- No active medical problems
HEALTHY VOLUNTEER EXCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY:
- less than 18 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
- 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
- Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgement of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/13/2009