Clinical trial: Collection of Lung Fluid and Tissue Samples for Research (NCT00471250)

Eligibility criteria:
-  HEALTHY VOLUNTEER INCLUSION CRITERIA FOR BRONCHOSCOPY AND BRONCHOSCOPIC 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 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:

               1. Complete blood count with differential

               2. Serum chemistries including creatinine, blood urea nitrogen, glucose, liver
                  enzymes and function tests, electrolytes

               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) (if the subject has not had a CXR or computerized
                  tomography [CT] scan of the chest within the prior7 days)

               8. Pulse oximetry

               9. Electrocardiogram (ECG)

              10. Treadmill exercise stress test (as indicated for history of angina or
                  abnormalities on ECG)

        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. [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

        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:

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

               2. 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

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

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

               5. History of pulmonary hypertension

               6. 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 10 years old

          -  Enrolled without regard to gender, race, or ethnicity

          -  NIH employees or non-employees 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

          -  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 , Nasal Nitric Oxide
        Measurement, and Nasal Potential Difference Measurement:

          -  Less than 10 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 or other measures

          -  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

          -  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, and
        Nasal Potential Difference Measurement

          -  Greater than or equal to 10 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, Nasal Nitric Oxide Measurement, and
        Nasal Potential Difference Measurement:

          -  Less than 10 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 or other measures

          -  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.

        Healthy Volunteer Inclusion Criteria for Sputum Induction and Exhaled Breath Condensate
        Collection

          1. greater than or equal to 10 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 and Exhaled Breath Condensate
        Collection

          1. < 10 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 and Exhaled Breath Condensate Collection:

          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 and Exhaled Breath Condensate Collection:

          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.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 10 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia.  The patient is sexually active with his wife and does not use any contraception methods.  They have been trying to conceive for the past year with no success.  The patient has a past medical history of recurrent pneumonia, shortness of breath, and  persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol.  The patient has no history of other medical conditions including allergies or any kind of surgery.  On physical examination, the digits show clubbing.  An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test.

Patient description (patient's own words): I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test.

Does the patient match the trial criteria? Contradiction