Search / Trial NCT00001888

Sample Collections From the Airways of Asthmatic Patients

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Nov 3, 1999

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Trial Information

Current as of December 26, 2024

Recruiting

Keywords

Induced Sputum Exhaled Breath Condensate Fiberoptic Bronchoscopy Bronchoscopy M Rna Natural History

ClinConnect Summary

This clinical trial is studying asthma by collecting samples from the airways of both patients with asthma and healthy volunteers. The researchers will use a procedure called fiberoptic bronchoscopy, which involves a thin tube that goes into the lungs to collect fluid and cells. This research aims to better understand how inflammation in the airways contributes to asthma.

To participate, you must be between 18 and 75 years old and have a diagnosis of asthma, which means you experience breathing difficulties that can improve with treatment. If you’re a woman who can get pregnant, you’ll need to have a negative pregnancy test and use reliable birth control. Healthy volunteers without asthma can also join, provided they meet certain criteria, like having no history of asthma or related lung conditions. Participants can expect to undergo the bronchoscopy procedure, which is done in a controlled medical environment, and contribute to important research that may help improve asthma treatments in the future.

Gender

ALL

Eligibility criteria

  • * INCLUSION CRITERIA:
  • ASTHMATICS:
  • • 1. Patients undergoing a research bronchoscopy will be between 18 and 75 years of age, male or female. The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation. In addition, patients will have demonstrated evidence of either an abnormal methacholine challenge or reversible airway obstruction. An abnormal methacholine challenge will be defined as a decrease in FEV1 of at least 20% at a PD20 dose \< 200 microgram. Reversible airway obstruction will be defined as an improvement of at least 10% in either the FEV1 or FVC following bronchodilator treatment. Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of reversible airflow obstruction.
  • • 2. For women of childbearing potential, negative pregnancy test and willingness to adhere to reliable birth control methods prior to
  • • bronchoscopy or sputum induction.
  • • 3. Asthmatic research subjects who will only be providing research blood specimens, nasal epithelial lining fluid, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may participate in the protocol by providing a clinical history that they have asthma and are not pregnant. Documentation of an abnormal methacholine challenge or reversible airflow obstruction or a negative pregnancy test, for women of childbearing age, will not be required for donation of research blood specimens, or other non-invasive samples, such as nasal epithelial lining fluid, sputum, or exhaled breath condensate.
  • EXCLUSION CRITERIA:
  • ASTHMATICS:
  • • Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, HIV-related lymphocytic airway inflammation).
  • • History of drug or alcohol abuse within the past year.
  • • Positive test for human immunodeficiency virus (to exclude patients with HIV-related lymphocytic airway inflammation) or hepatitis virus.
  • INCLUSION CRITERIA - RESEARCH VOLUNTEERS:
  • • 1. Research volunteers undergoing a research bronchoscopy will be between 18 and 75 years of age, male or female.
  • • 2. A negative inhalational methacholine challenge as defined by the absence of a 20% decrease in FEV1 at a PD20 dose of \> 400 microgram (normal bronchial hyperresponsiveness). Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of a negative methacholine challenge.
  • • 3. For women of childbearing potential, negative pregnancy test within 2 weeks prior to bronchoscopy and willingness to adhere to reliable birth control methods prior to bronchoscopy or sputum induction.
  • • 4. Research volunteers who will only be providing research blood specimens, nasal epithelial lining fluid, sputum, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may be included in the protocol without documentation of a negative inhalational methacholine challenge or a negative pregnancy test if they provide a history that they do not have asthma and that they are not currently pregnant, for women of childbearing age.
  • EXCLUSION CRITERIA - RESEARCH VOLUNTEERS:
  • • Same as the asthmatic exclusion criteria plus a history of asthma.

Trial Officials

Amisha V Barochia, M.D.

Principal Investigator

National Heart, Lung, and Blood Institute (NHLBI)

About National Heart, Lung, And Blood Institute (Nhlbi)

The National Heart, Lung, and Blood Institute (NHLBI) is a leading component of the National Institutes of Health (NIH), dedicated to advancing research and clinical trials focused on cardiovascular, pulmonary, and hematologic diseases. With a mission to improve public health through innovative research, the NHLBI supports a wide range of studies aimed at understanding, preventing, and treating heart and lung conditions. By collaborating with academic institutions, healthcare providers, and patient communities, the NHLBI strives to translate scientific discoveries into effective clinical practices, ultimately enhancing the quality of life for individuals affected by these critical health issues.

Locations

Bethesda, Maryland, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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