[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568303":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":29,"responsibleParty":50,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":26,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":26,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"University of Saskatchewan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tiotropium treatment","EXPERIMENTAL","2 puffs tiotropium",[13],"Drug: Tiotropium (Spiriva®)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","2 puffs placebo",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Tiotropium (Spiriva®)","2 puffs tiotropium prior to allergen challenge",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":28,"otherNames":26},[15],[30],{"facility":5,"status":26,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Saskatoon","Saskatchewan","S7M 2W2","Canada","CA",{"type":37,"coordinates":38},"Point",[39,40],-106.66892,52.13238,{"lat":40,"lon":39},[43,49],{"name":44,"role":45,"phone":46,"phoneExt":47,"email":48},"Brianne Philipenko, MD","CONTACT","306-956-3444","4","bsp943@mail.usask.ca",{"name":44,"role":45,"phone":26,"phoneExt":26,"email":26},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Brianne Philipenko","MD FRCPC","100568303","phase-4-evaluating-the-impact-of-single-dose-tiotropium-on-allergen-induced-early-asthmatic-response-100568303",false,"NCT06679465","Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response","Inclusion Criteria:\n\n* age (years) at least 18 years\n* no confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity as determined by the principal investigator)\n* baseline FEV1 ≥ 65% of predicted normal at Visit 1\n* evidence of atopy to an allergen suitable for inhalation challenge following skin prick testing such as house dust mite, grass, cat or horse\n* fall in FEV1 of ≥ 20% at a dose of methacholine ≤ 600mcg (methacholine PD20) at Visit 1\n* positive response to allergen inhalation challenge (fall in FEV1 of ≥ 15% after inhalation of allergen at a dilution 1:32 or more dillute.\n* absence of respiratory infection for at least 4 weeks prior to Visit 1\n* absence of significant worsening of asthma that requires health care intervention or prolonged change in medication due to allergen exposure (or other trigger) for at least 4 weeks prior to Visit 1\n* women of child-bearing potential shall not be pregnant or lactating\n* non-smoker (cigarettes, vaping); ex-smoker with \\\u003C10 pack year history allowed; cannabis use will be evaluated on a case-by-case basis\n* if on as needed budesonide\u002Fformoterol therapy, no reported use within 3 weeks prior to allergen challenge\n\nExclusion Criteria:\n\n* Smoker \\>10 pack year history","ALL","18 Years",{"count":63,"type":64},10,"ESTIMATED","INTERVENTIONAL",[67],"PHASE4","Evaluate single dose (2 x 2.5mcg\u002Fpuff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.",[70],"Asthma Bronchiale",[72,73,74],"asthma","Tiotropium","Early asthmatic response","NOT_YET_RECRUITING","2024-11-06",{"date":78,"type":79},"2024-11-07","ACTUAL",{"date":81,"type":64},"2025-01-01",{"date":83,"type":64},"2027-01",{"name":5,"class":6},1]