Nctid:
NCT00001462
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D019896", "term"=>"Alpha 1-Antitrypsin Deficiency"}, {"id"=>"D008171", "term"=>"Lung Diseases"}, {"id"=>"D011656", "term"=>"Pulmonary Emphysema"}, {"id"=>"D008173", "term"=>"Lung Diseases, Obstructive"}, {"id"=>"D004646", "term"=>"Emphysema"}], "ancestors"=>[{"id"=>"D012140", "term"=>"Respiratory Tract Diseases"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D029424", "term"=>"Pulmonary Disease, Chronic Obstructive"}, {"id"=>"D002908", "term"=>"Chronic Disease"}, {"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D008107", "term"=>"Liver Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}, {"id"=>"D030342", "term"=>"Genetic Diseases, Inborn"}, {"id"=>"D013352", "term"=>"Subcutaneous Emphysema"}], "browseLeaves"=>[{"id"=>"M11168", "name"=>"Lung Diseases", "asFound"=>"Lung Disease", "relevance"=>"HIGH"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}, {"id"=>"M11170", "name"=>"Lung Diseases, Obstructive", "asFound"=>"Lung Diseases, Obstructive", "relevance"=>"HIGH"}, {"id"=>"M14510", "name"=>"Pulmonary Emphysema", "asFound"=>"Emphysema", "relevance"=>"HIGH"}, {"id"=>"M7812", "name"=>"Emphysema", "asFound"=>"Emphysema", "relevance"=>"HIGH"}, {"id"=>"M21776", "name"=>"Alpha 1-Antitrypsin Deficiency", "asFound"=>"Alpha-1 Antitrypsin Deficiency", "relevance"=>"HIGH"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M23449", "name"=>"Pulmonary Disease, Chronic Obstructive", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M23686", "name"=>"Genetic Diseases, Inborn", "relevance"=>"LOW"}, {"id"=>"M16142", "name"=>"Subcutaneous Emphysema", "relevance"=>"LOW"}, {"id"=>"T297", "name"=>"Alpha-1 Antitrypsin Deficiency", "asFound"=>"Alpha-1 Antitrypsin Deficiency", "relevance"=>"HIGH"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M12507", "name"=>"Nitric Oxide", "relevance"=>"LOW"}, {"id"=>"M3856", "name"=>"Alpha 1-Antitrypsin", "relevance"=>"LOW"}, {"id"=>"M20205", "name"=>"Protein C Inhibitor", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "enrollmentInfo"=>{"count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1995-05"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-08", "completionDateStruct"=>{"date"=>"2000-04"}, "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"=>["Alpha 1-Antitrypsin Deficiency", "Emphysema", "Genetic Diseases", "Inflammation", "Nitric Oxide", "Protease"], "conditions"=>["Emphysema", "Lung Diseases, Obstructive", "Alpha 1-Antitrypsin Deficiency"]}, "referencesModule"=>{"references"=>[{"pmid"=>"2497126", "type"=>"BACKGROUND", "citation"=>"Buist AS. Alpha 1-antitrypsin deficiency in lung and liver disease. Hosp Pract (Off Ed). 1989 May 15;24(5):51-9. doi: 10.1080/21548331.1989.11703712. No abstract available."}, {"pmid"=>"2185272", "type"=>"BACKGROUND", "citation"=>"Crystal RG. Alpha 1-antitrypsin deficiency, emphysema, and liver disease. Genetic basis and strategies for therapy. J Clin Invest. 1990 May;85(5):1343-52. doi: 10.1172/JCI114578. No abstract available."}, {"pmid"=>"2117164", "type"=>"BACKGROUND", "citation"=>"Gadek JE, Pacht ER. The protease-antiprotease balance within the human lung: implications for the pathogenesis of emphysema. Lung. 1990;168 Suppl:552-64. doi: 10.1007/BF02718178."}, {"pmid"=>"31754065", "type"=>"DERIVED", "citation"=>"Paris AE, Vragovic O, Sonalkar S, Finneseth M, Borgatta L. Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15-18 weeks' gestation: a randomised controlled non-inferiority trial. BMJ Sex Reprod Health. 2019 Nov 21:bmjsrh-2019-200367. doi: 10.1136/bmjsrh-2019-200367. Online ahead of print."}]}, "descriptionModule"=>{"briefSummary"=>"Alpha 1-antitrypsin-deficient individuals develop severe destructive lung disease much earlier and their lung function declines faster than the general population of individuals with chronic obstructive lung disease. This study is designed to better understand the pathogenesis of lung destruction in alpha 1-antitrypsin deficient individuals and to characterize the pathobiology of early lung destruction. To accomplish this we intend to use bronchoalveolar lavage to determine and quantify the factors that initiate and sustain lung inflammation in alpha 1-antitrypsin deficient individuals with lung function above a force expiratory volume in one second (FEV1) of greater than 50% of predicted.", "detailedDescription"=>"Alpha 1-antitrypsin-deficient individuals develop severe destructive lung disease much earlier and their lung function declines faster than the general population of individuals with chronic obstructive lung disease. This study is designed to better understand the pathogenesis of lung destruction in alpha 1-antitrypsin deficient individuals and to characterize the pathobiology of early lung destruction. To accomplish this we intend to use bronchoalveolar lavage to determine and quantify the factors that initiate and sustain lung inflammation in alpha 1-antitrypsin deficient individuals with lung function above a force expiratory volume in one second (FEV1) of greater than 50% of predicted."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>true, "eligibilityCriteria"=>"Any alpha 1 antitrypsin-deficient individuals.\n\n18-65 years old.\n\nFEV1 greater than 1 equal to 50 percent of predicted (forced expiratory volume).\n\nStudy participation is required for one year.\n\nA total of four bronchoscopies will be performed over a year period.\n\nMethacholine challenge test will be performed at the beginning and end of the study to assess the degree of reactive airways disease.\n\nPneumococcal and annual influenza vaccine will be given.\n\nNo prolastin within one year prior to start of the study.\n\nNo oral systemic corticosteroids within 30 days prior to start of study.\n\nNo allergy to topical or local anesthetic (i.e., lidocaine).\n\nNo pregnancy.\n\nNo HIV positive patients.\n\nNo Hepatitis B/C virus positive patients.\n\nNo patients with any condition associated with immunodeficiency.\n\nNo patients with presence of significant cardiac diseases.\n\nNo patients with presence of uncorrected blood-clotting disorders.\n\nNo patients with any oxygen at home on a regular basis.\n\nNo adverse reactions to methacholine."}, "identificationModule"=>{"nctId"=>"NCT00001462", "briefTitle"=>"Characterization of the Pathobiology of Early Lung Destruction in Alpha 1-Antitrypsin Deficient Individuals", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"Characterization of the Pathobiology of Early Lung Destruction in Alpha 1-Antitrypsin Deficient Individuals", "orgStudyIdInfo"=>{"id"=>"950116"}, "secondaryIdInfos"=>[{"id"=>"95-H-0116"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Heart, Lung and Blood Institute (NHLBI)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Heart, Lung, and Blood Institute (NHLBI)", "class"=>"NIH"}}}}
