Collecting lung fluid and tissue samples to study infection susceptibility

Research Respiratory Tract Procedures

This study is collecting lung and nose samples from healthy people and those with past lung infections to see what makes some individuals more likely to get infections.

Quick facts

• Study type: Observational
• Enrollment: 550 (estimated)
• Ages: 5 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00471250 on ClinicalTrials.gov

What this trial studies

This research collects fluid and tissue specimens from the lungs and nose of both healthy individuals and those with a history of lung infections. The goal is to examine differences in these samples that may indicate susceptibility to certain infections. Participants undergo various procedures including bronchoscopy, sputum induction, and nasal biopsies, along with medical evaluations. The collected samples will be analyzed to better understand the immune response in the lungs.

Who should consider this trial

Good fit: Ideal candidates are healthy volunteers and individuals aged 18 to 75 with a history of lung infections.

Not a fit: Patients with significant underlying health conditions or those unable to undergo the required procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance our understanding of lung infection susceptibility and lead to improved prevention and treatment strategies.

How similar studies have performed: Other studies have successfully utilized similar approaches to investigate respiratory conditions, indicating potential for valuable insights.

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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (RECRUITING)

Study contacts

• Principal investigator: Andrew J Lipton, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Chevalia J Robinson, R.N.

Conditions: Leukocyte Disorders, Respiratory Tract Diseases, Bronchoscopy, Lung Infection Susceptibility, Bronchoalvealar lavage, Nasal Biopsy, Sputum Sample, Infection Susceptibility