[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597484":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":37,"locations":47,"responsibleParty":420,"collaborators":422,"id":433,"slug":434,"hasResults":435,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":435,"sex":441,"minAge":442,"maxAge":26,"enrollmentInfo":443,"targetDuration":26,"studyType":446,"phases":447,"briefSummary":449,"conditions":450,"keywords":453,"overallStatus":215,"whyStopped":26,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":461,"completionDateStruct":463,"leadSponsor":465,"locationsCount":466},{"fullName":5,"class":6},"Johns Hopkins University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Omalizumab injection","ACTIVE_COMPARATOR","Active treatment is omalizumab injection, dosed using standardized weight and total IgE based table, as used for asthma treatment",[13],"Drug: Omalizumab (Xolair®)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo injection","PLACEBO_COMPARATOR","Placebo for omalizumab used in the study will be commercially packaged 0.9% Sodium Chloride Injection, USP (e.g., normal saline). The injection volumes of normal saline administered will be calculated based upon the volume of active omalizumab expected to be administered based upon weight and total IgE level.",[19],"Drug: Sodium Chloride (NaCl) 0.9 %",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Omalizumab (Xolair®)","The study drug (omalizumab or placebo) will be given as a subcutaneous injection, which means an injection into the fat layer just under the skin in your arm or leg. This is similar to an insulin injection and not as deep as a typical vaccine injection. After the injection, participants will be monitored for any side effects. The study team will determine the dose and how often the injection is given based on the participant's weight and blood test results. Injections will be either be given monthly, 12 doses, or twice per month, 24 doses. All injections will be given at the clinic.",[9],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Sodium Chloride (NaCl) 0.9 %",[15],[31,35],{"name":32,"affiliation":33,"role":34},"Nirupama Putcha","Johns Hopkins School of Medicine","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Elizabeth Sugar, PhD",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":26,"email":42},"Kayla Long","CONTACT","410-502-9048","klong33@jhu.edu",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Heather Hazucha","410-502-0585","hhazuch1@jhu.edu",[48,69,86,103,120,137,154,167,180,197,214,228,245,261,277,290,302,319,336,352,369,386,403],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"University of Alabama","NOT_YET_RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-86.80249,33.52066,{"lat":60,"lon":59},[63,67],{"name":64,"role":40,"phone":65,"phoneExt":26,"email":66},"Necole Harris","205-934-9240","nharris@uabmc.edu",{"name":68,"role":34,"phone":26,"phoneExt":26,"email":26},"Michael Wells",{"facility":70,"status":50,"city":71,"state":72,"zip":73,"country":54,"countryCode":55,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"University of Arizona- Tuscon","Tucson","Arizona","85724",{"type":57,"coordinates":75},[76,77],-110.92648,32.22174,{"lat":77,"lon":76},[80,84],{"name":81,"role":40,"phone":82,"phoneExt":26,"email":83},"Alyssandra Rivera","520-626-6387","arivera59@arizona.edu",{"name":85,"role":34,"phone":26,"phoneExt":26,"email":26},"Fernando Martinez",{"facility":87,"status":50,"city":88,"state":89,"zip":90,"country":54,"countryCode":55,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"University of San Francisco","San Francisco","California","94143",{"type":57,"coordinates":92},[93,94],-122.41942,37.77493,{"lat":94,"lon":93},[97,101],{"name":98,"role":40,"phone":99,"phoneExt":26,"email":100},"Shannen Rico","415-203-8234","shannen.recio@ucsf.edu",{"name":102,"role":34,"phone":26,"phoneExt":26,"email":26},"Stephanie Christenson",{"facility":104,"status":50,"city":105,"state":106,"zip":107,"country":54,"countryCode":55,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"National Jewish Health","Denver","Colorado","80206",{"type":57,"coordinates":109},[110,111],-104.9847,39.73915,{"lat":111,"lon":110},[114,118],{"name":115,"role":40,"phone":116,"phoneExt":26,"email":117},"Juno Pak","303-398-1443","pakj@njhealth.org",{"name":119,"role":34,"phone":26,"phoneExt":26,"email":26},"Barry Make",{"facility":121,"status":50,"city":122,"state":123,"zip":124,"country":54,"countryCode":55,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"University of Florida","Jacksonville","Florida","32209",{"type":57,"coordinates":126},[127,128],-81.65565,30.33218,{"lat":128,"lon":127},[131,135],{"name":132,"role":40,"phone":133,"phoneExt":134,"email":26},"Alexis Luis","904-244-0908","Alexis.Luis@ja",{"name":136,"role":34,"phone":26,"phoneExt":26,"email":26},"Vandana Seeram",{"facility":138,"status":50,"city":139,"state":140,"zip":141,"country":54,"countryCode":55,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"University of Illinois at Chicago","Chicago","Illinois","60608",{"type":57,"coordinates":143},[144,145],-87.65005,41.85003,{"lat":145,"lon":144},[148,152],{"name":149,"role":40,"phone":150,"phoneExt":26,"email":151},"Lauren Greene","224-239-5683","greene56@uic.edu",{"name":153,"role":34,"phone":26,"phoneExt":26,"email":26},"Lynn Gerald",{"facility":155,"status":50,"city":139,"state":140,"zip":156,"country":54,"countryCode":55,"cosmosGeoPoint":157,"geoPoint":159,"contacts":160},"Northwestern University","60611",{"type":57,"coordinates":158},[144,145],{"lat":145,"lon":144},[161,165],{"name":162,"role":40,"phone":163,"phoneExt":26,"email":164},"Jenny Hixon","312-926-0975","j-franzen@northwestern.edu",{"name":166,"role":34,"phone":26,"phoneExt":26,"email":26},"Ravi Kalhan",{"facility":168,"status":50,"city":139,"state":140,"zip":169,"country":54,"countryCode":55,"cosmosGeoPoint":170,"geoPoint":172,"contacts":173},"Rush University Medical Center","60612",{"type":57,"coordinates":171},[144,145],{"lat":145,"lon":144},[174,178],{"name":175,"role":40,"phone":176,"phoneExt":26,"email":177},"Jessica Parumoottil","312-563-2168","Jessica_Parumoottil@rush.edu",{"name":179,"role":34,"phone":26,"phoneExt":26,"email":26},"James Moy",{"facility":181,"status":50,"city":182,"state":183,"zip":184,"country":54,"countryCode":55,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"University of Iowa","Iowa City","Iowa","52242",{"type":57,"coordinates":186},[187,188],-91.53017,41.66113,{"lat":188,"lon":187},[191,195],{"name":192,"role":40,"phone":193,"phoneExt":26,"email":194},"Eric Garcia","319-353-8862","eric-garcia@uiowa.edu",{"name":196,"role":34,"phone":26,"phoneExt":26,"email":26},"Alejandro Comellas",{"facility":198,"status":50,"city":199,"state":200,"zip":201,"country":54,"countryCode":55,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"University of Kansas Medical Center","Kansas City","Kansas","66160",{"type":57,"coordinates":203},[204,205],-94.62746,39.11417,{"lat":205,"lon":204},[208,212],{"name":209,"role":40,"phone":210,"phoneExt":26,"email":211},"Nicole Hall","913-588-1987","nhall@kumc.edu",{"name":213,"role":34,"phone":26,"phoneExt":26,"email":26},"Mario 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Han",{"facility":246,"status":50,"city":247,"state":231,"zip":248,"country":54,"countryCode":55,"cosmosGeoPoint":249,"geoPoint":253,"contacts":254},"Henry Ford Health","Detroit","48202",{"type":57,"coordinates":250},[251,252],-83.04575,42.33143,{"lat":252,"lon":251},[255,259],{"name":256,"role":40,"phone":257,"phoneExt":26,"email":258},"Muzhda Hashmi","313-900-5452","mhashmi2@hfhs.org",{"name":260,"role":34,"phone":26,"phoneExt":26,"email":26},"Alan Baptist",{"facility":262,"status":50,"city":263,"state":263,"zip":264,"country":54,"countryCode":55,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"Mount Sinai, Icahn School of Medicine","New York","10029",{"type":57,"coordinates":266},[267,268],-74.00597,40.71427,{"lat":268,"lon":267},[271,275],{"name":272,"role":40,"phone":273,"phoneExt":26,"email":274},"Maria Wong","212-241-2779","mariaantonia.wong@mssm.edu",{"name":276,"role":34,"phone":26,"phoneExt":26,"email":26},"Linda Rogers",{"facility":278,"status":50,"city":263,"state":263,"zip":279,"country":54,"countryCode":55,"cosmosGeoPoint":280,"geoPoint":282,"contacts":283},"Columbia University","10032",{"type":57,"coordinates":281},[267,268],{"lat":268,"lon":267},[284,288],{"name":285,"role":40,"phone":286,"phoneExt":26,"email":287},"Jotti Saroya","212-305-0251","tks2127@cumc.columbia.edu",{"name":289,"role":34,"phone":26,"phoneExt":26,"email":26},"Emily DiMango",{"facility":291,"status":50,"city":263,"state":263,"zip":279,"country":54,"countryCode":55,"cosmosGeoPoint":292,"geoPoint":294,"contacts":295},"Cornell University",{"type":57,"coordinates":293},[267,268],{"lat":268,"lon":267},[296,300],{"name":297,"role":40,"phone":298,"phoneExt":26,"email":299},"Jose Romero","212-305-4675","jlr4002@med.cornell.edu",{"name":301,"role":34,"phone":26,"phoneExt":26,"email":26},"Robery Kaner",{"facility":303,"status":50,"city":304,"state":305,"zip":306,"country":54,"countryCode":55,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"Duke University Medical Center","Durham","North Carolina","27705",{"type":57,"coordinates":308},[309,310],-78.89862,35.99403,{"lat":310,"lon":309},[313,317],{"name":314,"role":40,"phone":315,"phoneExt":26,"email":316},"Kaitlin Foy","919-479-0861","kaitlin.jones@duke.edu",{"name":318,"role":34,"phone":26,"phoneExt":26,"email":26},"Loretta Que",{"facility":320,"status":50,"city":321,"state":322,"zip":323,"country":54,"countryCode":55,"cosmosGeoPoint":324,"geoPoint":328,"contacts":329},"Temple University","Philadelphia","Pennsylvania","19140",{"type":57,"coordinates":325},[326,327],-75.16362,39.95238,{"lat":327,"lon":326},[330,334],{"name":331,"role":40,"phone":332,"phoneExt":26,"email":333},"Francine McGonagle","215-707-2682","Francine.McGonagle@tuhs.temple.edu",{"name":335,"role":34,"phone":26,"phoneExt":26,"email":26},"Nathaniel Marchetti",{"facility":337,"status":50,"city":338,"state":322,"zip":339,"country":54,"countryCode":55,"cosmosGeoPoint":340,"geoPoint":344,"contacts":345},"University of Pittsburgh","Pittsburgh","15213",{"type":57,"coordinates":341},[342,343],-79.99589,40.44062,{"lat":343,"lon":342},[346,350],{"name":347,"role":40,"phone":348,"phoneExt":26,"email":349},"Tiffany Ditter","412-648-6276","dittertl2@upmc.edu",{"name":351,"role":34,"phone":26,"phoneExt":26,"email":26},"Frank Sciurba",{"facility":353,"status":50,"city":354,"state":355,"zip":356,"country":54,"countryCode":55,"cosmosGeoPoint":357,"geoPoint":361,"contacts":362},"Vanderbilt University Medical Center","Nashville","Tennessee","37203",{"type":57,"coordinates":358},[359,360],-86.78444,36.16589,{"lat":360,"lon":359},[363,367],{"name":364,"role":40,"phone":365,"phoneExt":26,"email":366},"Courtney Lehman","615-421-8172","courtney.a.lehman@vumc.org",{"name":368,"role":34,"phone":26,"phoneExt":26,"email":26},"Katherine Cahill",{"facility":370,"status":50,"city":371,"state":372,"zip":373,"country":54,"countryCode":55,"cosmosGeoPoint":374,"geoPoint":378,"contacts":379},"Baylor College of Medicine","Houston","Texas","77030",{"type":57,"coordinates":375},[376,377],-95.36327,29.76328,{"lat":377,"lon":376},[380,384],{"name":381,"role":40,"phone":382,"phoneExt":26,"email":383},"Laura Bertrand","713-798-2681","laura.bertrand@bcm.tmc.edu",{"name":385,"role":34,"phone":26,"phoneExt":26,"email":26},"Nicola Hanania",{"facility":387,"status":50,"city":388,"state":389,"zip":390,"country":54,"countryCode":55,"cosmosGeoPoint":391,"geoPoint":395,"contacts":396},"University of Vermont","Colchester","Vermont","05446",{"type":57,"coordinates":392},[393,394],-73.14791,44.54394,{"lat":394,"lon":393},[397,401],{"name":398,"role":40,"phone":399,"phoneExt":26,"email":400},"Olivia Garrow","802-847-2160","olivia.johnson@uvmhealth.org",{"name":402,"role":34,"phone":26,"phoneExt":26,"email":26},"Anne Dixon",{"facility":404,"status":50,"city":405,"state":406,"zip":407,"country":54,"countryCode":55,"cosmosGeoPoint":408,"geoPoint":412,"contacts":413},"Pacific Northwest Airways - VA Puget Sound Healthcare System, Seattle","Seattle","Washington","98108",{"type":57,"coordinates":409},[410,411],-122.33207,47.60621,{"lat":411,"lon":410},[414,418],{"name":415,"role":40,"phone":416,"phoneExt":26,"email":417},"Brianna Moss","206-277-4166","Brianna.Moss@va.gov",{"name":419,"role":34,"phone":26,"phoneExt":26,"email":26},"Laura Freemster",{"type":421,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[423,426,429,431],{"name":424,"class":425},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",{"name":427,"class":428},"Genentech, Inc.","INDUSTRY",{"name":430,"class":6},"American Lung Association Asthma Clinical Research Centers",{"name":432,"class":6},"American Lung Association","100597484","phase-2-clinical-trial-of-omalizumab-for-allergen-sensitized-and-exposed-individuals-with-copd-100597484",false,"NCT07059091","Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD","Clinical Trial of Omalizumab for Allergen Sensitized and Exposed Individuals With COPD (COPD-OMA)","COPD-OMA","Inclusion Criteria:\n\n* Able and willing to provide informed consent.\n* Age \\>40 years at screening.\n* Combustible tobacco cigarette exposure \\>10 pack-years.\n* Self-report of physician diagnosis of COPD and currently on dual or triple long-acting inhaled therapy (ICS\u002FLABA\u002FLAMA, ICS\u002FLABA, LABA\u002FLAMA).\n* COPD Assessment Test (CAT) score of \\>15 OR history of at least one documented moderate (requiring treatment with oral corticosteroids) or severe (requiring ED visit or hospitalization) COPD exacerbation in the past year.\n* Participants of childbearing potential must have negative pregnancy test upon study entry.\n* Female (and male) participants with reproductive potential must agree to use FDA approved methods of contraception for duration of study.\n* Post-bronchodilator FEV1\u002FFVC ratio \\\u003C 0.7 and FEV1% predicted \\\u003C 80%.\n* Sensitization to one or more of five common indoor allergens including cat, dog, mouse, cockroach, dust mite defined with positive skin prick test (SPT) (SPT wheal size at least 3 mm greater than negative control). Positive specific IgE testing within 12 months of randomization to cat, dog, mouse, cockroach, or dust mite will be accepted in lieu of skin prick test if SPT is not interpretable or SPT cannot be safely performed.\n* Exposure to the same allergen to which individual is sensitized based on measurement in home settled dust (1 U\u002Fg cockroach, 1 μg\u002Fg mouse, 2 μg\u002Fg dust mite, (Der f 1), 8 μg\u002Fg for cat and dog).\n\nExclusion Criteria:\n\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol.\n* Live in a location other than home (i.e., care facility)\n* Actively breastfeeding.\n* Current asthma diagnosis.\n* Other lung disease (cystic fibrosis, pneumoconiosis, bronchiectasis or otherwise) that is considered the primary respiratory diagnosis and would interfere with participation in the study\n* Reduced life expectancy due to other disease that in the opinion of the investigator may interfere with participation in the study.\n* Participants with severe medical condition(s) that in the view of the investigator prohibits participation in the study.\n* Received or listed for a lung transplant.\n* Surgical or bronchoscopic lung volume reduction surgery in the 12 months prior to screening.\n* History of infection or active infection due to Mycobacterium tuberculosis\n* Active parasitic infection diagnosed and\u002For treated within 6 months of randomization\n* Currently receiving allergen immunotherapy.\n* History of anaphylaxis from medications, foods or otherwise.\n* Current active prescription for epinephrine autoinjector for treatment of severe chronic urticaria.\n* Known sensitivity to study drug(s) or another biologic medication.\n* Use of any other investigational agent for COPD in the last 90 days. If the other investigational agent being used is a biologic agent, this must be washed out for 6 months prior to randomization.\n* Active use of biologic medication (monoclonal antibody) for treatment of respiratory disease in the past 6 months (benralizumab, omalizumab, mepolizumab, resilizumab, dupliumab, tezepelumab, or other similar medication or use of biologic medication for treatment of any non-respiratory disease in the past 3 months.\n* Use of chronic systemic corticosteroids at doses above 10mg daily prednisone or the equivalent.\n* Use of systemic corticosteroid course for acute exacerbation of COPD within 4 weeks of randomization.\n* Weight \\\u003C 66 or \\>330 lbs; and total IgE \\\u003C 30 IU\u002FmL or \\>700 IU\u002FmL; or no available dosing recommendation based on weight and total IgE level.\n* No ICS in background regimen for individuals with blood eosinophil count of \\>300 and systemic steroid requiring exacerbation in the past year, except in case of contraindication to ICS such as thrush, osteoporosis, or pneumonia in the past year.","ALL","40 Years",{"count":444,"type":445},334,"ESTIMATED","INTERVENTIONAL",[448],"PHASE2","This research is being done to test if a drug called omalizumab can help people with Chronic Obstructive Pulmonary Disease (COPD) and allergies.\n\nEach participant will be in the study for about 16 months, including 1-3 months of screening, 12 months of receiving the study drug at a clinic, and a follow-up call one month after your final clinic visit.",[451,452],"Chronic Obstructive Pulmonary Disease (COPD)","Allergies",[454,455,456],"lung disease","COPD","allergies","2026-02-13",{"date":459,"type":460},"2026-02-17","ACTUAL",{"date":462,"type":460},"2026-02-12",{"date":464,"type":445},"2031-05",{"name":5,"class":6},23]