Sample Collections From the Airways of Asthmatic Patients
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|ClinicalTrials.gov Identifier: NCT00001888|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : May 26, 2022
|First Submitted Date||November 3, 1999|
|First Posted Date||November 4, 1999|
|Last Update Posted Date||May 26, 2022|
|Actual Study Start Date||June 2, 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||Assess the role of apolipoprotein and lipid pathways in asthmatic and non-asthmatic subjects. [ Time Frame: ongoing ]
These studies will increase the understanding of the pathogenic mechanisms underlying asthmatic airway inflammation and may identify novel therapeutic targets.
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||Sample Collections From the Airways of Asthmatic Patients|
|Official Title||Asthma Sample Collection Protocol|
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.
|Detailed Description||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.|
|Study Design||Observational Model: Case-Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||Any individual between the ages of 18 and 75 with asthma will be accepted into the study. Since asthma has a roughly equivalent prevalence in groups differing in race and gender, recruitment of study participants will be aimed at selecting a study population which reflect this diversity. Asthmatic or research volunteers with HIV infection will be excluded from the study so as not to include patients with HIV-related lymphocytic airway inflammation. Volunteers will be obtained through the NIH Clinical Research Volunteer Program or other standard channels at NIH.|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
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:
EXCLUSION CRITERIA - RESEARCH VOLUNTEERS:
Same as the asthmatic exclusion criteria plus a history of asthma.
|Ages||18 Years to 75 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||Yes|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||990076
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||
|IPD Sharing Statement||
|Current Responsible Party||National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )|
|Original Responsible Party||Not Provided|
|Current Study Sponsor||National Heart, Lung, and Blood Institute (NHLBI)|
|Original Study Sponsor||Same as current|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 17, 2022|