[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549089":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":49,"responsibleParty":82,"collaborators":44,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":44,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":52,"whyStopped":44,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University of KwaZulu","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"budesonide\u002Fformoterol group","EXPERIMENTAL","Budesonide-formoterol fumarate dihydrate at two dose strengths 80\u002F4.5 and 160\u002F4.5 administered via a pressurized metered dose inhaler (pMDI) or dry powder inhaler (DPI), respectively. The dosing will be dependent on asthma symptom severity ranging from 1 dose as needed and titrated up or down depending on asthma control.",[13],"Drug: Budesonide\u002Fformoterol",{"label":15,"type":16,"description":17,"interventionNames":18},"comparator: standard of care group","ACTIVE_COMPARATOR","Standard of care",[19],"Drug: standard of care",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Budesonide\u002Fformoterol","The Investigational Medicinal Product (IMP) consists of a combination of Budesonide (corticosteroid) and Formoterol Furamate (fast-acting β2 agonist) dihydrate. The IMP is currently available and registered in dry powder form turbuhaler (Symbicort) and a pressurised metered dose inhaler (Vannair).\n\nThe recommended doses are pMDI\u002FDPI 80\u002F4.5 1-2 puffs twice daily OR 1 puff as needed (a maximum daily dose of 8 puffs) for children 6-11 years of age and 160\u002F4.5 1-2 inhalations twice daily or 1 puff as needed (a maximum daily dose of 12 puffs) for adolescents 12-18 years.",[9],[27],"No other intervention names",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"standard of care","Any therapy that is prescribed as per asthma guidelines i.e. beclomethasone, budesonide and salbutamol, montelukast etc",[15],[33],"beclomethasone or budesonide & salbutamol or mentelukast",[35],{"name":36,"affiliation":37,"role":38},"Limakatso Lebina, PhD","Africa Health Research Institute","STUDY_DIRECTOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Refiloe Masekela, PhD","CONTACT","800-555-5555",null,"masekelar@ukzn.ac.za",{"name":47,"role":42,"phone":43,"phoneExt":44,"email":48},"Nompumelelo Ngobese","nompumelelo.ngobese@ahri.org",[50,73],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Africa Research Health Institute Clinical Trial Unit","RECRUITING","Mtubatuba","KwaZulu-Natal","3935","South Africa","ZA",{"type":59,"coordinates":60},"Point",[61,62],32.18483,-28.41789,{"lat":62,"lon":61},[65,69,70],{"name":66,"role":42,"phone":67,"phoneExt":44,"email":68},"Sbekezelo Hlophe","0720238851","sbehlophe@gmail.com",{"name":47,"role":42,"phone":44,"phoneExt":44,"email":48},{"name":71,"role":72,"phone":44,"phoneExt":44,"email":44},"Refiloe Masekela","PRINCIPAL_INVESTIGATOR",{"facility":51,"status":52,"city":53,"state":54,"zip":74,"country":56,"countryCode":57,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"3965",{"type":59,"coordinates":76},[61,62],{"lat":62,"lon":61},[79,80,81],{"name":66,"role":42,"phone":43,"phoneExt":44,"email":68},{"name":47,"role":42,"phone":44,"phoneExt":44,"email":48},{"name":71,"role":72,"phone":44,"phoneExt":44,"email":44},{"type":83,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100549089","phase-3-anti-inflammatory-reliever-south-africa-100549089",false,"NCT06429475","Anti-Inflammatory Reliever South Africa","Anti-Inflammatory Reliever Therapy for Asthma Using Inhaled Budesonide\u002FFormoterol As-needed With or Without Maintenance in South African Children: A Pragmatic Open Label Phase 3 Randomised Controlled Trial","AIRSA001","Inclusion Criteria:\n\n* Age for inclusion children and adolescents 6-18 years at the time of consent\n* Known asthmatic on treatment.\n* Newly diagnosed asthma based on investigator review and\u002For medical report.\n* All patients will have their asthma diagnosis confirmed (both new or known asthmatic patients) by either spirometry with reversibility or excessive diurnal variability by PEFR twice daily over 2 weeks.\n* Ability to perform Peak Expiratory Flow rate and\u002For bronchodilator reversibility testing.\n* Only participants with mild, or moderate asthma , based on medical history\n* At least one exacerbation of asthma in the past year as defined by an event requiring treatment with systemic corticosteroids for ≥3 days and\u002For a hospitalisation\u002Femergency room visit for asthma requiring treatment with systemic corticosteroids.\n* Written consent from the participant or parent\u002Fguardian and assent from study participants where applicable.\n* Participant and\u002For parent\u002Fguardian agrees to comply with the study procedures, including the completion of the visits and be available for contact for telephonically for the non-contact visits\n\nExclusion Criteria:\n\n* Tuberculosis (TB): active TB disease and contact with people with active TB disease in the last 6 months.\n* Chronic sputum expectoration, chest pain, shortness of breath, dizziness, or light-headedness in the last 2 months.\n* Cardiac arrythmia.\n* Chronic conditions: thyrotoxicosis, phaeochromocytoma, cardiovascular disease, severe hypertension.\n* Uncontrolled diabetes mellitus\n* Patients with Peak Expiratory Flow Rate \\\u003C 50% of predicted , as these would be classified as severe asthmatics.\n* Patients with any history of life-threatening asthma, defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).\n* Any use of biological therapy or immunomodulatory therapy such as methotrexate or regular oral prednisolone for the asthma management (STEP 5 GINA therapy).\n* Any surgical or medical condition that would significantly alter the absorption, distribution, metabolism or excretion of the IMP which may jeopardise the safety of the participants. The investigator should make this determination in consideration of the volunteer's medical history.\n* Any physical, mental or social condition, laboratory abnormality of history of illness that in the investigator's judgement might jeopardise the safety of the participant in the context of the study or might interfere with study procedures or the ability of the participant to adhere to and complete the study. The investigator should make this determination consideration of the volunteer's medical history.\n* Inability to present for follow-up or leaving the study area within 12 months of enrolment.","ALL","6 Years","18 Years",{"count":96,"type":97},1038,"ESTIMATED","INTERVENTIONAL",[100],"PHASE3","This is a Phase 3 single-centre open label randomised controlled trial with two equal sized groups to assess the efficacy of budesonide\u002Fformoterol 80\u002F4.5 (6-11 years) and 160\u002F4.5 (12-18 years) compared to the standard of care in reducing asthma exacerbations over 52 weeks.\n\nChildren and adolescents with a diagnosis of asthma or newly diagnosed with asthma will be screened for eligibility for enrolment. Those who had an asthma exacerbation in the previous year will be randomised 1:1, to either receive budesonide\u002Fformoterol inhaler for both symptom relief and for chronic anti- inflammatory maintenance therapy or the standard of care which is separate inhalers for symptom relief (short acting bronchodilator salbutamol) and chronic maintenance therapy with inhaled corticosteroids (beclomethasone or budesonide) and\u002For long-acting beta agonists or montelukast as determined by treating physicians. All asthma exacerbations and clinic\u002Fhospital admissions will be recorded for the duration of the 52-week follow-up. Participants will be followed up at 13, 26, 39 and 52 weeks. The 13- and 39-week visit will be telephonic visits to capture the primary end-point i.e. asthma exacerbations. Adverse events and medication changes data will also be collected.\n\nAn independent Data and Safety Monitoring Board (DSMB) will be convened for this study with expertise in asthma and asthma clinical trials. The purpose of the DSMB will be to monitor the study for safety and operational futility with pre-defined stopping criteria. In addition, a Trial Steering Committee (TSC) will also provide overall supervision of the trial and ensure the trial is delivered in accordance with ICH-GCP. The TSC has been established with an independent Chair and include additional independent members including an observer early career researcher. Representatives of the Trial Funder (NIHR) and Sponsor (AHRI) will be invited to all TSC meetings.",[103],"Asthma",[105,106,107,108,109,110],"asthma","budesonide\u002Fformoterol","beclomethasone","budesonide","children","adolescents","2026-01-13",{"date":113,"type":114},"2026-01-15","ACTUAL",{"date":116,"type":114},"2024-06-06",{"date":118,"type":97},"2028-12-31",{"name":5,"class":6},2]