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Scientists scour lungs for clues to why some get infections

NCT ID NCT00471250

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 14 times

Summary

This study gathers fluid and tissue from the lungs and nose of healthy volunteers and people with a history of lung infections. Researchers will compare samples to find differences in immune function that might explain why some people are more prone to infections. Participants undergo procedures like bronchoscopy and nasal scrapes. The goal is to support future research, not to test a new treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2007

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Healthy volunteers and NIH patients with known or suspected susceptibility to infection.@@@@@@

Ages

5 to 100 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

* 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(TM) or Versed(TM), 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(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, 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National Institutes of Health Clinical Center

    RECRUITING

    Bethesda, Maryland, 20892, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.