[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615147":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":38,"centralContacts":45,"locations":55,"responsibleParty":72,"collaborators":38,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":38,"enrollmentInfo":87,"targetDuration":38,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":58,"whyStopped":38,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Indiana University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects with Primary Ciliary Dyskinesia","EXPERIMENTAL","Subjects will come to Riley Hospital for Children for at least two visits with the opportunity for a third visit. Each visit should take between 2 and 2.5 hours. During the visits, subjects will complete multiple breathing tests, inhale certain medications, complete a family history questionnaire, have skin allergy testing, and do a blood draw.",[13,14,15,16],"Procedure: Lung Function Testing","Procedure: Phlebotomy","Procedure: Allergy skin prick testing","Procedure: Methacholine Challenge",{"label":18,"type":10,"description":11,"interventionNames":19},"Healthy Subjects",[13,14,15,16],[21,28,34,39],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Lung Function Testing","will include baseline spirometry (pre- and post- max bronchodilator). All testing will be done according to American Thoracic Society\u002FEuropean Respiratory Society guidelines. Participants will be asked to refrain from taking any asthma medications, including inhaled corticosteroids, short- and long-acting bronchodilators, leukotriene receptor antagonists, and long-acting muscarinic antagonists, for 24 hours prior to any spirometry. This activity will take place at a clinical research center at the respective participating institution.",[18,9],[27],"spirometry",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Phlebotomy","will be obtained at visit 2. Up to ten (10) ml of blood will be collected for measurement of serum biomarkers of atopy, based on whether participants prefer to receive an allergy skin prick test or have antigen-specific IgE levels tested. In the event a subject refuses phlebotomy, historical results up to one year old may be used in lieu of prospective results. Any remaining blood samples will be banked either for use in future studies or in the event that additional serum biomarkers are added to this study.",[18,9],[33],"blood draw",{"type":22,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Allergy skin prick testing","may be completed at visit 2. Subjects will be instructed to withhold first-generation antihistamines for 3 days and second-generation antihistamines for 7 days prior to the test. If patients prefer to have serum antigen-specific IgE levels run with the required serum biomarkers of atopy, then skin prick testing will be omitted.",[18,9],null,{"type":22,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Methacholine Challenge","If the subject does not demonstrate a bronchodilator response in FEV1 of 10% or greater, and does not have a historical MCT on file, MCT will be performed. Following inhalation of saline, methacholine (MCh) will be inhaled in quadrupling concentrations starting with 0.0625 mg\u002Fml and continuing until the MCh concentration required for FEV1 to decrease by 20% from baseline (PD20) is achieved or a maximum MCh concentration of 16 mg\u002Fml is inhaled.",[18,9],[44],"MCT",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":38,"email":50},"Fanmuyi Yang, PhD","CONTACT","317-274-8895","fy5@iu.edu",{"name":52,"role":48,"phone":53,"phoneExt":38,"email":54},"Lisa Bendy","317-278-7152","lbendy@iu.edu",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Riley Hospital for Children","RECRUITING","Indianapolis","Indiana","46202","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-86.15804,39.76838,{"lat":68,"lon":67},[71],{"name":47,"role":48,"phone":38,"phoneExt":38,"email":38},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Evans Machogu","Professor of Clinical Pediatrics","100615147","examining-bronchial-hyperresponsiveness-in-primary-ciliary-dyskinesia-100615147",false,"NCT07288827","Examining Bronchial Hyperresponsiveness in Primary Ciliary Dyskinesia","A Multi-center Study Examining Bronchial Hyperresponsiveness in Primary Ciliary Dyskinesia","BHR","Inclusion Criteria:\n\n* Confirmed diagnosis of PCD per standard diagnostic criteria4 and positive genetics\n* Age greater than or equal to 6 years (no upper age limit)\n* Any gender or race\n* Able to perform pulmonary function testing (historical documentation of reversibility will be accepted)\n\nExclusion Criteria:\n\n* history of current pneumothorax\n* inability to perform pulmonary function testing",true,"ALL","6 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"NA","The purpose of this study is to look at children with PCD and see if they have another condition called \"bronchial hyperresponsiveness\".",[95,96],"Primary Ciliary Dyskinesia","Healthy",[95,98],"bronchial hyperresponsiveness","2025-12-03",{"date":101,"type":102},"2025-12-17","ACTUAL",{"date":104,"type":102},"2023-05-04",{"date":106,"type":89},"2028-04-30",{"name":5,"class":6},1]