[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498649":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":29,"centralContacts":33,"locations":40,"responsibleParty":61,"collaborators":64,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":38,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":38,"overallStatus":43,"whyStopped":38,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Duke University","OTHER",[8,13,17],{"label":9,"type":6,"description":10,"interventionNames":11},"Cohort 1","no history of respiratory viral infection",[12],"Drug: Ozone",{"label":14,"type":6,"description":15,"interventionNames":16},"Cohort 2","Documented mild respiratory viral infection",[12],{"label":18,"type":6,"description":19,"interventionNames":20},"Cohort 3","Respiratory viral pneumonia",[12],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Ozone","Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).",[9,14,18],[28],"O3",[30],{"name":31,"affiliation":5,"role":32},"Robert Tighe, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Claudia Salazar","CONTACT","9196602026",null,"claudia.salazar@duke.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Duke University Medical Center","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-78.89862,35.99403,{"lat":53,"lon":52},[56,59],{"name":57,"role":36,"phone":58,"phoneExt":38,"email":39},"Claudia Salazar, BS","919-660-2026",{"name":60,"role":32,"phone":38,"phoneExt":38,"email":38},"Robert Tigher, MD",{"type":62,"investigatorFullName":31,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"SPONSOR_INVESTIGATOR","Associate Professor of Medicine",[65,68],{"name":66,"class":67},"National Institutes of Health (NIH)","NIH",{"name":69,"class":67},"National Institute of Environmental Health Sciences (NIEHS)","100498649","phase-1-macrophage-regulation-of-ozone-induced-lung-inflammation-100498649",false,"NCT05773001","Macrophage Regulation of Ozone-Induced Lung Inflammation","MOLI","Inclusion Criteria:\n\n* Individuals between 18-55 yrs. of age (No subject will be excluded from the study on the basis of gender or ethnicity)\n* Individuals with knowledge of prior respiratory viral infection history allowing them to be segregated into one of three cohorts\n\n  * Cohort 1 - No history of respiratory viral infection (defined as no symptoms consistent with respiratory viral infection nor history of a positive respiratory viral test)\n  * Cohort 2 - Documented mild respiratory viral infection (a positive test, either PCR- or antigen-based) but with mild to no symptoms and no evidence of a lower respiratory tract infection (including no hospitalization, and no oxygen use)\n  * Cohort 3 - History of respiratory viral infection and symptoms\u002Fimaging consistent with a lower respiratory tract infection who have recovered, are \\>6 months out from their infection, and have normal lung function (spirometry with FVC, FEV1 and FEV1\u002FFVC)\n\n    * There will be no maximal period from respiratory viral infection for inclusion in the study, the minimal period will be \\>6 months out from infection\n\nExclusion Criteria:\n\n* Individuals with prior respiratory viral pneumonia who have ongoing respiratory symptoms, are still using supplemental oxygen, or have abnormal lung function\n* Current smokers of tobacco products including e-cigarettes or those with previous smoking history within the prior 5 years\n* Pregnant women and women who are presently lactating.\n* Subjects that have received antibiotic administration or an upper respiratory infection within the previous 4 weeks\n* College and graduate students or employees who are under direct supervision by any of the investigators in this protocol\n* Alcohol or illicit substance abuse\n* Chronic cardio\u002Fpulmonary respiratory disorders or other medical conditions as determined by the investigator\n* Increased airway hyperresponsiveness at baseline as measured by a positive methacholine challenge response (methacholine PC20 FEV1 \\\u003C 4 mg\u002Fml)\n* Subjects will be requested to refrain from antihistamines, nonsteroidal anti-inflammatory agents, antioxidants (e.g. beta-carotene, selenium, and lutein) and supplemental vitamins (e.g. C and E), for 1 week prior to, and during testing.",true,"ALL","18 Years","55 Years",{"count":82,"type":83},100,"ESTIMATED","INTERVENTIONAL",[86],"PHASE1","The purpose of this research study to understand how prior respiratory infections affect the susceptibility to lung inflammation following environmental exposures.",[89],"Respiratory Viral Infection","2026-05-13",{"date":92,"type":93},"2026-05-15","ACTUAL",{"date":95,"type":93},"2023-05-18",{"date":97,"type":83},"2028-05",{"name":31,"class":6},1]