Collection of Lung Fluid and Tissue Samples for Research (NCT00471250) | Clinical Trial Compass
RecruitingNot Applicable
Collection of Lung Fluid and Tissue Samples for Research
United States550 participantsStarted 2007-08-17
Plain-language 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 The brush is withdrawn with some tissue adhering to it.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)
Who can participate
Age range5 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18 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
Exclusion criteria
✕. \<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.
What they're measuring
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...
Timeframe: 10 years
Trial details
NCT IDNCT00471250
SponsorNational Heart, Lung, and Blood Institute (NHLBI)
✕. 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).