View Clinical Trial (Medical Research Study)
Fiberoptic Bronchoscopy in Patients With Asthma
| City: |
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Bethesda |
| State: |
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Maryland |
| Zip Code: |
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20892 |
| Conditions: |
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Asthma - Healthy |
| Purpose: |
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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.
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| Study Summary: |
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This tissue procurement protocol proposes to perform fiberoptic bronchoscopy with
bronchoalveolar lavage, bronchial brushings exhaled brath condensates, and bronchial wall
biopsies to evaluate the molecular mechanisms underlying the pathogenesis of airway
inflammation and remodeling in asthmatic patients. The objective of this protocol is to
assess the expression, regulation, and function of proteins regulating the release of
soluble receptors and mediators from asthmatic inflammatory and structural cell populations,
with a focus on the role of exosome-associated proteins and receptors in the regulation of
airway inflammatory responses.
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| Criteria: |
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- 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 either an abnormal methacholine challenge or evidence of
ongoing reversible airway obstruction. An abnormal methacholine challenge will be defined
as a decrease in FEV(1) of at least 20% following inhalation of less than or equal to 4
mg/ml of methacholine. Ongoing 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.
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, bronchiectasis, HIV-related lymphocytic airway inflammation).
Respiratory tract infection or asthma exacerbation within 4 weeks of screening.
History of adverse reactions to lidocaine or other local anesthetics.
Allergy to methacholine.
Use of aspirin within 2 weeks of the bronchoscopic study or non-steroidal
anti-inflammatory agents within 2 days of the bronchoscopic study.
History of cigarette smoking within the past 3 months.
History of drug or alcohol abuse.
Positive test for human immunodeficiency virus (to exclude patients with HIV-related
lymphocytic airway inflammation).
Post-bronchodilator FEV1 < 40% of predicted or pre-bronchodilator FEV1 < 35% of
predicted. .
Active bronchospasm on physical examination.
History of lidocaine allergy.
History of prior cardiac disease.
For Bronchial Biopsies: PT and PTT greater than ULN.
For Bronchial Brushings or BAL:
- PT greater than 1 second above ULN or INR greater than 1.3.
- PTT greater than 1 second above ULN.
Platelet less than 150,00/ml.
Hemoglobin less than 12 gm/dl for males and less than 11 gm/dl for females.
Serum Creatine greater than 2.0.
Liver function tests greater than 2 times upper limit of normal.
Any condition that, in the investigator's opinion, places the patient at undue risk for
complications from fiberoptic bronchoscopy, bronchalveolar lavage, bronchial brushings, or
bronchial biopsies.
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, following inhalation of 16 mg/ml of methacholine.
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.
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| NCT ID: |
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NCT00001888 |
| Primary Contact: |
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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: kalerm@nhlbi.nih.gov
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| Backup Contact: |
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Email: levines@nhlbi.nih.gov
Stewart J Levine, M.D.
Phone: (301) 402-1553
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| Location Contact: |
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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: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
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