Bethesda, Maryland 20892


Purpose:

Fiberoptic bronchoscopy is a procedure which involves passing a pencil-thin tube into the lung in order to collect fluid and cells from the airways. Fiberoptic bronchoscopy can collect cells from the walls of airways by gently brushing them (bronchial brushing). In addition, squirting small amounts of sterile water in to the airway and gently suctioning it back into the bronchoscope (bronchoalveolar lavage) collects cells. In this study, researchers plan to perform these tests on patients with asthma and normal volunteers. This research may help to improve the understanding of the processes involved in airway inflammation and asthma.


Study summary:

This tissue procurement protocol proposes to perform bronchoscopy with bronchoalveolar lavage, bronchial brushings, and bronchial wall biopsies as well as to collect samples of sputum, exhaled breath condensates and blood, in order to evaluate the molecular mechanisms underlying the pathogenesis of airway inflammation, airway hyperresponsiveness, and airway remodeling in asthmatic subjects.


Criteria:

- INCLUSION CRITERIA: ASTHMATICS: Patients 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 FEV(1) of at least 20% at a PD(20) dose less than 240 micrograms. Reversible airway obstruction will be defined as an improvement of at least 12% and 200 cc in either the FEV(1) or FVC folowing bronchodilator treatment. Methacholine challenge testing will not be performed if the subject has a history of allergy to methoacholine. Result of testing performed by the subject's primary care provider may be accepted as evidence of reversible airflow obstruction. For women of childbearing potential, negative pregnancy test prior to study and willingness to adhere to reliable birth control methods during the study. 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). INCLUSION CRITERIA - RESEARCH VOLUNTEERS: Research volunteers will be between 18 and 75 years of age, male or female. A negative inhalational methacholine challenge as defined bv the absence of a 20% decrease in FEV(1), at a PD(20) dose of >960 micrograms (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. For women of childbearing potential, negative pregnancy test within 2 weeks prior to study and willingness to adhere to reliable birth control methods during the study. EXCLUSION CRITERIA - RESEARCH VOLUNTEERS: Same as the asthmatic exclusion criteria plus a history of asthma.


NCT ID:

NCT00001888


Primary Contact:

Principal Investigator
Stewart J Levine, M.D.
National Heart, Lung, and Blood Institute (NHLBI)

Maryann M Kaler, C.R.N.P.
Phone: (301) 451-5916
Email: mk371e@nih.gov


Backup Contact:

Email: levines@nhlbi.nih.gov
Stewart J Levine, M.D.
Phone: (301) 402-1553


Location Contact:

Bethesda, Maryland 20892
United States

For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)
Phone: 800-411-1222
Email: prpl@mail.cc.nih.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 22, 2017

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