Nctid:
NCT00001759
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D011014", "term"=>"Pneumonia"}, {"id"=>"D001249", "term"=>"Asthma"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D014890", "term"=>"Granulomatosis with Polyangiitis"}, {"id"=>"D006967", "term"=>"Hypersensitivity"}, {"id"=>"D007249", "term"=>"Inflammation"}], "ancestors"=>[{"id"=>"D001982", "term"=>"Bronchial Diseases"}, {"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D008173", "term"=>"Lung Diseases, Obstructive"}, {"id"=>"D012130", "term"=>"Respiratory Hypersensitivity"}, {"id"=>"D006969", "term"=>"Hypersensitivity, Immediate"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D017563", "term"=>"Lung Diseases, Interstitial"}, {"id"=>"D056648", "term"=>"Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis"}, {"id"=>"D056647", "term"=>"Systemic Vasculitis"}, {"id"=>"D014657", "term"=>"Vasculitis"}, {"id"=>"D014652", "term"=>"Vascular Diseases"}, {"id"=>"D002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D017445", "term"=>"Skin Diseases, Vascular"}, {"id"=>"D012871", "term"=>"Skin Diseases"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D012141", "term"=>"Respiratory Tract Infections"}, {"id"=>"D007239", "term"=>"Infections"}], "browseLeaves"=>[{"id"=>"M4556", "name"=>"Asthma", "asFound"=>"Asthma", "relevance"=>"HIGH"}, {"id"=>"M13904", "name"=>"Pneumonia", "asFound"=>"Lung Inflammation", "relevance"=>"HIGH"}, {"id"=>"M11168", "name"=>"Lung Diseases", "asFound"=>"Lung Disease", "relevance"=>"HIGH"}, {"id"=>"M10293", "name"=>"Inflammation", "asFound"=>"Inflammation", "relevance"=>"HIGH"}, {"id"=>"M10018", "name"=>"Hypersensitivity", "asFound"=>"Hypersensitivity", "relevance"=>"HIGH"}, {"id"=>"M17630", "name"=>"Granulomatosis with Polyangiitis", "asFound"=>"Wegener's Granulomatosis", "relevance"=>"HIGH"}, {"id"=>"M28526", "name"=>"Systemic Vasculitis", "relevance"=>"LOW"}, {"id"=>"M5258", "name"=>"Bronchial Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M11170", "name"=>"Lung Diseases, Obstructive", "relevance"=>"LOW"}, {"id"=>"M14967", "name"=>"Respiratory Hypersensitivity", "relevance"=>"LOW"}, {"id"=>"M10020", "name"=>"Hypersensitivity, Immediate", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M19813", "name"=>"Lung Diseases, Interstitial", "relevance"=>"LOW"}, {"id"=>"M17405", "name"=>"Vasculitis", "relevance"=>"LOW"}, {"id"=>"M28527", "name"=>"Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M15674", "name"=>"Skin Diseases", "relevance"=>"LOW"}, {"id"=>"M19714", "name"=>"Skin Diseases, Vascular", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M14978", "name"=>"Respiratory Tract Infections", "relevance"=>"LOW"}, {"id"=>"T2610", "name"=>"Granulomatosis With Polyangiitis", "asFound"=>"Wegener's Granulomatosis", "relevance"=>"HIGH"}, {"id"=>"T375", "name"=>"ANCA-associated Vasculitis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M21686", "name"=>"Fluorodeoxyglucose F18", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"count"=>95}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1997-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-02", "completionDateStruct"=>{"date"=>"2001-01"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Allergy", "Fluorodeoxyglucose", "Imaging", "PET", "Wegener's Granulomatosis", "Asthma"], "conditions"=>["Asthma", "Hypersensitivity", "Lung Diseases", "Wegener's Granulomatosis"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8087134", "type"=>"BACKGROUND", "citation"=>"Floreani AA, Buchalter S, Thompson AB, Rennard SI. In vivo assessment of airway inflammation. Monaldi Arch Chest Dis. 1994 Jun;49(3 Suppl 1):17-26."}, {"pmid"=>"8598758", "type"=>"BACKGROUND", "citation"=>"Taylor IK, Hill AA, Hayes M, Rhodes CG, O'Shaughnessy KM, O'Connor BJ, Jones HA, Hughes JM, Jones T, Pride NB, Fuller RW. Imaging allergen-invoked airway inflammation in atopic asthma with [18F]-fluorodeoxyglucose and positron emission tomography. Lancet. 1996 Apr 6;347(9006):937-40. doi: 10.1016/s0140-6736(96)91416-6."}, {"pmid"=>"1530827", "type"=>"BACKGROUND", "citation"=>"Robinson DS, Hamid Q, Ying S, Tsicopoulos A, Barkans J, Bentley AM, Corrigan C, Durham SR, Kay AB. Predominant TH2-like bronchoalveolar T-lymphocyte population in atopic asthma. N Engl J Med. 1992 Jan 30;326(5):298-304. doi: 10.1056/NEJM199201303260504."}]}, "descriptionModule"=>{"briefSummary"=>"Asthma is a chronic inflammatory disease. We propose to study inflammatory changes in the lungs of subjects with atopic asthma of different severity in vivo using positron emission tomography (PET) with 2-deoxy-2-\\[18F\\]fluoro-D-glucose (FDG). It has been shown that the uptake of FDG as detected by PET scanning correlates with inflammation in animal models as well as in human disease processes such as sarcoidosis, tuberculosis and abscess formation. In addition, it has been shown that the inflammation associated with allergen challenge in patients with atopic asthma can be visualized using PET scanning with FDG. We hypothesize that the degree of FDG-uptake as a measure of inflammation correlates with the severity of asthma as determined by pulmonary function tests and clinical signs and symptoms. In addition, information about the spatial distribution of the inflammatory changes will be obtained. To compare the characteristics of the inflammation in asthma with non-asthmatic inflammation of the lung, the images obtained in asthmatic subjects will be compared with images from subjects who have inflammatory changes of the lung caused by Wegener's granulomatosis. Subjects with atopic asthma and non-atopic control subjects will be selected from the community and, if eligible for the study, undergo skin testing against common allergens and pulmonary function testing. Subjects with Wegener's granulomatosis will be selected from a large group of subjects followed with this disease at NIAID. PET scanning with FDG will be used to measure inflammation in the PET scanning facility at the Clinical Center of the NIH and the results of the scanning will be correlated with the severity of the disease. We expect that for the first time this methodology will permit an objective measure of the basic pathogenic process, the allergic inflammation, in patients with atopic asthma. Using this methodology it will be possible to study the efficacy of currently available therapies for allergic inflammation. In addition, this methodology will provide an extremely useful tool for the development of new therapeutic approaches to the treatment of asthma.", "detailedDescription"=>"Asthma is a chronic inflammatory disease. We propose to study inflammatory changes in the lungs of subjects with atopic asthma of different severity in vivo using positron emission tomography (PET) with 2-deoxy-2-\\[18F\\]fluoro-D-glucose (FDG). It has been shown that the uptake of FDG as detected by PET scanning correlates with inflammation in animal models as well as in human disease processes such as sarcoidosis, tuberculosis and abscess formation. In addition, it has been shown that the inflammation associated with allergen challenge in patients with atopic asthma can be visualized using PET scanning with FDG. We hypothesize that the degree of FDG-uptake as a measure of inflammation correlates with the severity of asthma as determined by pulmonary function tests and clinical signs and symptoms. In addition, information about the spatial distribution of the inflammatory changes will be obtained. To compare the characteristics of the inflammation in asthma with non-asthmatic inflammation of the lung, the images obtained in asthmatic subjects will be compared with images from subjects who have inflammatory changes of the lung caused by Wegener's granulomatosis. Subjects with atopic asthma and non-atopic control subjects will be selected from the community and, if eligible for the study, undergo skin testing against common allergens and pulmonary function testing. Subjects with Wegener's granulomatosis will be selected from a large group of subjects followed with this disease at NIAID. PET scanning with FDG will be used to measure inflammation in the PET scanning facility at the Clinical Center of the NIH and the results of the scanning will be correlated with the severity of the disease. We expect that for the first time this methodology will permit an objective measure of the basic pathogenic process, the allergic inflammation, in patients with atopic asthma. Using this methodology it will be possible to study the efficacy of currently available therapies for allergic inflammation. In addition, this methodology will provide an extremely useful tool for the development of new therapeutic approaches to the treatment of asthma."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"Subjects must be between 18 and 55 years of age.\n\nNegative pregnancy test within two days of the scan and willingness to adhere to reliable birth control until the completion of the protocol.\n\nSubjects must be able to give informed consent.\n\nSubjects in the negative control group must have no history of asthma or other lung disease.\n\nControl subjects must have negative prick skin tests to the allergens used.\n\nAsthmatic subjects must have asthma as defined in this study.\n\nAsthmatic subjects must have positive prick skin tests to one or more allergens used.\n\nSubjects must have access to a primary medical care provider outside of the NIH.\n\nSubjects must weigh less than 136 kg.\n\nNo breast feeding.\n\nNo smoking in the last 3 years, or greater than 6 months of smoking in the past ten years.\n\nNo antihistamines one week prior to the skin test on the first visit.\n\nNo history of coronary artery disease.\n\nNo evidence of lung disease other than asthma; no evidence of autoimmune or inflammatory disease which could affect lung function such as lupus erythematosus (except for the control subjects with Wegener's granulomatosis).\n\nNo evidence of either acute (e.g., bacterial or viral pneumonia) or chronic (e.g., bronchiectasis) lung infection.\n\nNo diabetes, or history of glucose intolerance (e.g., gestational diabetes).\n\nNo allergy to methacholine.\n\nNo beta-adrenergic blocking medication.\n\nControl subjects must not have a history of asthma, atopic rhinitis or atopic dermatitis.\n\nControl subjects must not have any response to inhaled methacholine with a fall in FEV1 in excess of 20% to less than or equal to 25 mg/ml.\n\nAsthmatic subjects must not have chronic bronchitis or a diagnosis of chronic obstructive lung disease (COPD)."}, "identificationModule"=>{"nctId"=>"NCT00001759", "briefTitle"=>"Assessment of Lung Inflammation in Patients With Atopic Asthma Using Positron Emission Tomography", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Assessment of Lung Inflammation in Patients With Atopic Asthma Using Positron Emission Tomography", "orgStudyIdInfo"=>{"id"=>"980044"}, "secondaryIdInfos"=>[{"id"=>"98-I-0044"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "class"=>"NIH"}}}}
