[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427642":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":31,"locations":37,"responsibleParty":61,"collaborators":31,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":31,"overallStatus":84,"whyStopped":31,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Bond Avillion 2 Development LP","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"A\u002FB - Treatment with BDA MDI (PT027) 160\u002F180 μg followed by treatment with Pulmicort Respules 1mg","EXPERIMENTAL","Subjects randomized to receive a single dose of budesonide\u002Falbuterol by metered-dose inhaler, BDA MDI, (PT027) 160\u002F180 μg at Visit 2, and a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 3.",[13,14],"Drug: BDA MDI (PT027) 160\u002F180 μg","Drug: Pulmicort Respules 0.5 MG\u002FML Inhalation Suspension",{"label":16,"type":10,"description":17,"interventionNames":18},"B\u002FA - Treatment with Pulmicort Respules 1 mg followed by treatment with BDA MDI (PT027) 160\u002F180 μg","Subjects randomized to receive a single dose of budesonide by nebulization (Pulmicort Respules) 1mg at Visit 2, and a single dose of budesonide\u002Falbuterol by metered-dose inhaler, BDA MDI, (PT027) 160\u002F180 μg at Visit 3.",[13,14],[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","BDA MDI (PT027) 160\u002F180 μg","Combination Product: Budesonide\u002Falbuterol sulfate metered-dose inhaler 80\u002F90 μg per puff. Two puffs to administer 160\u002F180 μg dose.",[9,16],[26],"PT027",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Pulmicort Respules 0.5 MG\u002FML Inhalation Suspension","Budesonide 0.5 mg\u002Fml. Each 2 ml Respule contains 1 mg budesonide.",[9,16],null,[33],{"name":34,"affiliation":35,"role":36},"Frank Albers, MD, PhD","Avillion LLP","STUDY_DIRECTOR",[38,51],{"facility":39,"status":31,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":31},"IPS Research","Oklahoma City","Oklahoma","73106","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-97.51643,35.46756,{"lat":49,"lon":48},{"facility":52,"status":31,"city":53,"state":54,"zip":55,"country":43,"countryCode":44,"cosmosGeoPoint":56,"geoPoint":60,"contacts":31},"TTS Research","Boerne","Texas","78006",{"type":46,"coordinates":57},[58,59],-98.73197,29.79466,{"lat":59,"lon":58},{"type":62,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100427642","phase-1-to-compare-the-pharmacokinetics-of-budesonide-delivered-by-bda-mdi-to-budesonide-delivered-by-pulmicort-respules-in-children-with-asthma-aged-4-to-8-years-100427642",true,"NCT04848662","To Compare the Pharmacokinetics of Budesonide Delivered by BDA MDI to Budesonide Delivered by Pulmicort Respules in Children With Asthma Aged 4 to 8 Years.","A Phase I, Randomized, Open-label, Single-dose, 2-way Crossover Study to Compare the Pharmacokinetics of Budesonide Delivered by PT027 to Pulmicort Respules® in Children With Asthma Aged 4 to 8 Years (BLANC)","BLANC","Inclusion Criteria:\n\n1. Provision of informed consent prior to any study specific procedures. Children should provide assent to join the study, as applicable. The child's parent(s) or legally authorized representative (LAR) must sign the informed consent form (ICF). The LAR must be aged ≥18 years old.\n2. Male or female aged between 4 and 8 years inclusive (not having reached his\u002Fher 9th birthday by the time of screening).\n3. Weigh at least 14 kg or higher.\n4. Clinician diagnosed asthma of at least 3 months.\n5. Stable on treatment with albuterol PRN and\u002For ICS and\u002For leukotriene receptor antagonists (LTRAs) for 2 weeks prior to screening; children taking budesonide in any form at Visit 1 will be switched to another corticosteroid with a washout of budesonide of 3 to 7 days.\n6. Demonstrate ability to correctly use the nebulizer and metered-dose inhaler (MDI) device without a spacer.\n7. Willingness and ability of the child and parent(s)\u002FLAR to comply with the demands of the study as described in the informed consent\u002Fassent.\n\nExclusion Criteria:\n\n1. Inability to change from any budesonide therapy to another suitable corticosteroid.\n2. History of life-threatening asthma defined as any asthma episode associated with loss of consciousness, intubation or admission to an intensive care unit.\n3. Unstable asthma as judged by the Investigator (eg, any change in asthma therapy within 2 weeks prior to screening or use of more than 2 occasions of rescue medication (albuterol) per day within 1 week prior to screening (potential for rescreen).\n4. Children receiving regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication (inhaled, nebulized, oral, or systemic) within 1 month prior to screening.\n5. More than 1 short course of oral\u002Frectal\u002Fsystemic corticosteroids within 6 months preceding screening (Visit 1), or any oral\u002Frectal\u002Fsystemic corticosteroids within 30 days prior to screening.\n6. Evidence of active concomitant pulmonary disease other than asthma (children with stable allergic rhinitis will be permitted, as long as, there are no changes in the treatment and the medications do not interfere with the analytical assay methods).\n7. Upper respiratory infection involving antibiotic treatment not resolved within 14 days prior to Visit 1.\n8. Children with a known or suspected hypersensitivity to albuterol\u002Fsalbutamol, budesonide or any of the excipients used in the IMPs.",false,"ALL","4 Years","8 Years",{"count":76,"type":77},12,"ACTUAL","INTERVENTIONAL",[80],"PHASE1","To compare the pharmacokinetics of budesonide delivered by BDA MDI to budesonide delivered by Pulmicort Respules in children with Asthma aged 4 to 8 years.",[83],"Asthma","COMPLETED","2022-04-12",{"date":87,"type":77},"2022-05-11",{"date":89,"type":77},"2021-05-06",{"date":91,"type":77},"2021-07-08",{"name":5,"class":6},2]