Collection of Lung Fluid and Tissue Samples for Research

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · May 8, 2007

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how lung infections affect the body. Researchers will collect fluid and tissue samples from both healthy individuals and those who have had lung infections. By comparing these samples, they hope to find out what makes some people more likely to get infections than others. This study is open to adults aged 18 to 75, including healthy volunteers and those with a history of lung infections, who are receiving care at the National Institutes of Health (NIH).

Participants will go through a variety of procedures, such as a medical check-up, blood and urine tests, and a bronchoscopy. A bronchoscopy involves using a thin tube to look inside the lungs and collect samples. Participants will receive sedatives for comfort during this procedure. They should be in good health, able to provide consent, and arrange for a ride home afterward. Importantly, they’re also asked to fast for several hours before and after the procedure. This study is a chance to contribute to important research that could help improve our understanding of lung health and infections.

Gender

ALL

Eligibility criteria

• * HEALTHY VOLUNTEER INCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES:
• • 1. 18 to 75 years of age inclusive
• • 2. Enrolled without regard to gender, race, or ethnicity
• • 3. NIH staff are eligible
• • 4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• • 5. Able and willing to complete the 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
• • 9. In good general health without clinically significant medical history
• • 10. Physical examination without clinically significant findings
• 11. 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
• • Urinalysis
• • Female subjects must have negative urine pregnancy test within 1 week of participation and continue birth control practices prior to participation
• • Chest radiograph (CXR) (if the subject has not had a CXR or computerized tomography \[CT\] scan of the chest within the prior 7 days)
• • Pulse oximetry
• • Electrocardiogram (ECG)
• • Treadmill exercise stress test (as indicated for history of angina or abnormalities on ECG)
• HEALTHY VOLUNTEER EXCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC PROCEDURES:
• • 1. \<18 or \>75 years old
• • 2. A smoking history of 10 pack-years or more, a current smoker, or tobacco free for less than a year.
• • 3. Positive HIV status. Subjects must have a negative FDA-approved HIV blood test. \[Note: Results of HIV enzyme-linked immunosorbent assay (ELISA) will be documented, but a negative HIV polymerase chain reaction (PCR) test result will be sufficient for eligibility screening of subjects with positive HIV ELISA that is due to prior participation in an HIV vaccine study\]
• • 4. Acute or chronic hepatitis based on viral hepatitis serologies
• • 5. Pregnancy or breastfeeding
• • 6. 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
• • 7. History of allergic reaction to lidocaine, sedative medications like Valium Trademark or Versed Trademark, or narcotic medications like morphine or fentanyl
• • 8. 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).
• • 9. Use of platelet inhibitors including aspirin and nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days of procedure
• • 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
• • 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. \<18 or \>75 years old
• 2. History of recent/acute clinically significant pulmonary compromise. This will be defined by the following criteria:
• • New lung infection or change in status of chronic lung infection or significant new findings on chest x-ray or CT scan
• • 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
• • Clinically significant reactive airway disease that does not respond to bronchodilators
• • Unstable chronic lung disease such as Chronic Obstructive Pulmonary Disease (COPD) or pulmonary fibrosis
• • History of pulmonary hypertension
• • 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 Trademark) 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 Trademark or Versed Trademark, 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, NASAL NITRIC OXIDE MEASUREMENT, AND NASAL POTENTIAL DIFFERENCE MEASUREMENT:
• • 1. \>= 5 years old
• • 2. Enrolled without regard to gender, race, or ethnicity
• • 3. NIH staff are eligible
• • 4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• • 5. Able and willing to complete the informed consent process
• • 6. Willing to donate blood and respiratory tract samples for storage to be used for future research
• • 7. Stable vital signs
• HEALTHY VOLUNTEER EXCLUSION CRITERIA FOR NASAL MUCOSAL BIOPSY, NASAL NITRIC OXIDE MEASUREMENT, AND NASAL POTENTIAL DIFFERENCE MEASUREMENT:
• • 1. \<5 years old
• • 2. 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
• • 3. History of turbinectomy or significant nasal pathology that would preclude obtaining mucosal scrape biopsies or other measures
• • 4. 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
• • 5. The use of nasal steroids in the past 6 weeks
• • 6. 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, NASAL NITRIC OXIDE MEASUREMENT, NASAL POTENTIAL DIFFERENCE MEASUREMENT, SPUTUM INDUCTION, COUGH AEROSOL SAMPLING, EXHALED AEROSOL MASK SAMPLE COLLECTION, COLLECTION OF EXHALED PARTICLES, AND LCI:
• • 1. \>= 5 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 NASAL MUCOSAL BIOPSY, NASAL NITRIC OXIDE MEASUREMENT, NASAL POTENTIAL DIFFERENCE MEASUREMENT, SPUTUM INDUCTION, COUGH AEROSOL SAMPLING, EXHALED AEROSOL MASK SAMPLE COLLECTION, COLLECTION OF EXHALED PARTICLES, AND LCI:
• • 1. \<5 years old
• • 2. Significant uncontrolled hay fever symptoms or recent or active upper respiratory tract infection, such as a cold or sinusitis
• • 3. History of turbinectomy or significant nasal pathology that would preclude obtaining mucosal scrape biopsies or other measures
• • 4. 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
• • 5. 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 SPUTUM INDUCTION, EXHALED BREATH CONDENSATE COLLECTION COUGH AEROSOL SAMPLING, EXHALED AEROSOL MASK SAMPLE COLLECTION, COLLECTION OF EXHALED PARTICLES, AND LCI:
• • 1. \>= 5 years old
• • 2. Enrolled without regard to gender, race, or ethnicity
• • 3. NIH employees or non-employees eligible
• • 4. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• • 5. Able and willing to complete the informed consent process
• • 6. Willing to donate blood and respiratory tract samples for storage to be used for future research
• • 7. Stable vital signs
• HEALTHY VOLUNTEER EXCLUSION CRITERIA FOR SPUTUM INDUCTION, EXHALED BREATH CONDENSATE COLLECTION, COUGH AEROSOL SAMPLING, EXHALED AEROSOL MASK SAMPLE COLLECTION, COLLECTION OF EXHALED PARTICLES, AND LCI:
• • 1. \< 5 years old
• • 2. History of 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
• PATIENT INCLUSION CRITERIA FOR SPUTUM INDUCTION, EXHALED BREATH CONDENSATE COLLECTION, COUGH AEROSOL SAMPLING, EXHALED AEROSOL MASK SAMPLE COLLECTION, COLLECTION OF EXHALED PARTICLES, AND LCI:
• • 1. \>= 5 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 INDUCTION, EXHALED BREATH CONDENSATE, COUGH AEROSOL SAMPLING, EXHALED AEROSOL MASK SAMPLE COLLECTION, COLLECTION OF EXHALED PARTICLES, AND LCI:
• • 1. \< 5 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.