[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580792":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":53,"centralContacts":60,"locations":70,"responsibleParty":85,"collaborators":87,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":101,"sex":102,"minAge":103,"maxAge":104,"enrollmentInfo":105,"targetDuration":44,"studyType":108,"phases":109,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":73,"whyStopped":44,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"University of North Carolina, Chapel Hill","OTHER",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Wood smoke followed by LAIV","EXPERIMENTAL","Participants will receive LAIV after a 2 hour wood smoke exposure.",[13,14],"Biological: LAIV nasal vaccine is chosen as a model viral infection","Other: Wood smoke",{"label":16,"type":17,"description":18,"interventionNames":19},"Wood smoke followed by Placebo","ACTIVE_COMPARATOR","Participants will receive a LAIV placebo after a 2 hour wood smoke exposure.",[14,20],"Biological: Placebo for LAIV nasal vaccine is chosen as a model viral infection",{"label":22,"type":17,"description":23,"interventionNames":24},"Clean Air followed by LAIV","Participants will receive LAIV after a 2 hour clean air exposure.",[13,25],"Other: Placebo for Wood Smoke (clean Air Exposure)",{"label":27,"type":28,"description":29,"interventionNames":30},"Clean Air followed by Placebo","PLACEBO_COMPARATOR","Participants will receive a LAIV placebo after a 2 hour clean air exposure.",[20,25],[32,40,45,49],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BIOLOGICAL","LAIV nasal vaccine is chosen as a model viral infection","Inoculation with LAIV",[22,9],[38,39],"Live Attenuated Influenza Vaccine","Flumist",{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Wood smoke","Wood smoke exposure concentrations at 500 ug\u002Fm3 for two hours.",[9,16],null,{"type":33,"name":46,"description":47,"armGroupLabels":48,"otherNames":44},"Placebo for LAIV nasal vaccine is chosen as a model viral infection","Placebo for LAIV inoculation. Nasal administration of normal saline.",[27,16],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":44},"Placebo for Wood Smoke (clean Air Exposure)","Clean Air Exposure for 2 hours",[22,27],[54,58],{"name":55,"affiliation":56,"role":57},"Meghan Rebuli, PhD","UNC","PRINCIPAL_INVESTIGATOR",{"name":59,"affiliation":56,"role":57},"Terry Noah, MD",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":44,"email":65},"Carole Robinette, MS","CONTACT","919 966-5638","carole_robinette@med.unc.edu",{"name":67,"role":63,"phone":44,"phoneExt":68,"email":69},"Chris Brooks","(919) 843-6598","chris_brooks@med.unc.edu",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":44},"Mary Ellen Jones","RECRUITING","Chapel Hill","North Carolina","27599","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-79.05584,35.9132,{"lat":83,"lon":82},{"type":86,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[88,91],{"name":89,"class":90},"National Institutes of Health (NIH)","NIH",{"name":92,"class":90},"National Institute of Environmental Health Sciences (NIEHS)","100580792","phase-4-woodsmoke-exposure-influenza-infection-and-nasal-immunity-100580792",false,"NCT06841913","Woodsmoke Exposure, Influenza Infection, and Nasal Immunity","The Effects of Woodsmoke Exposure on Nasal Immune Responses to Influenza Infection in Normal Human Volunteers","SmokeyFlu","Inclusion Criteria:\n\n* Normal lung function,\n* oxygen saturation of \\>94%,\n* normal blood pressure,\n* no respiratory symptoms on history, no abnormalities on exam, normal pulmonary function testing,\n* 18-49 Years of age.\n\nExclusion Criteria:\n\n* A history of significant chronic illnesses (to include diabetes, autoimmune diseases, immunodeficiency state, known ischemic heart disease, chronic respiratory diseases such as chronic obstructive pulmonary disease or asthma, hypertension)\n* Positive pregnancy test within 48 hours of the time of challenge\n* Use of any inhaled substance (for medical or recreational purposes).\n* Nonsmokers must have been abstinent from smoking for the prior 12 months, having not smoked more than 1 pack over the course of the previous year.\n* History of allergy to eggs\n* Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally resolved symptomatically for 3 weeks\n* Unspecified illnesses, which in the judgment of the investigator increase the risk associated with the experimental LAIV infection, will be a basis for exclusion.\n* Expected exposure of subject to immunocompromised individuals (who can be infected by LAIV) for the 3 weeks following LAIV inoculation.\n* Use of immunosuppressive drugs within the past 6 months.\n* Previous Woodsmoke exposure \\\u003C3 weeks, which is considered to an appropriate washout period",true,"ALL","18 Years","49 Years",{"count":106,"type":107},112,"ESTIMATED","INTERVENTIONAL",[110],"PHASE4","This study will investigate the effects of woodsmoke (WS) exposure on human nasal mucosal immune responses to viral infection. The study tests the hypotheses that WS exposure modifies biomarkers of nasal mucosal immune function, increases in Live Attenuated Influenza Virus (LAIV) -induced nasal symptoms, and reduces mucosal antibody production.",[113,114],"Smoke Exposure","Influenza",[116,39,114,117,118,119],"LAIV","Wood Smoke","Smoke","Fire","2026-04-24",{"date":122,"type":123},"2026-04-30","ACTUAL",{"date":125,"type":123},"2025-09-26",{"date":127,"type":107},"2028-12-31",{"name":5,"class":6},1]