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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | August 24, 2009 | ||||||||
| Start Date ICMJE | March 1999 | ||||||||
| Estimated Primary Completion Date | February 2002 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00001888 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Sample Collections From the Airways of Asthmatic Patients | ||||||||
| Official Title ICMJE | Fiberoptic Bronchoscopy in Patients With Asthma | ||||||||
| Brief Summary | 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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| Detailed Description | This tissue procurement protocol proposes to perform fiberoptic bronchoscopy with bronchoalveolar lavage, bronchial brushings 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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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 99999999 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | February 2002 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
ASTHMATICS: Patients will be between 18 and 65 years of age, male or female. The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation. Patients will be between 18 and 65 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). Severe asthma as defined by a FEV(1) less than 60 percent 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:
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 65 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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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001888 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 990076, 99-H-0076 | ||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | December 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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