{"id":"placebo-to-budesonide-inhaler","safety":{"commonSideEffects":[{"rate":"5-10","effect":"Oral candidiasis"},{"rate":"5-10","effect":"Dysphonia/hoarseness"},{"rate":"1-5","effect":"Tremor"},{"rate":"5-10","effect":"Headache"},{"rate":"5-10","effect":"Throat irritation"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Budesonide acts as a topical corticosteroid in the lungs, binding to intracellular glucocorticoid receptors and modulating gene transcription to decrease production of inflammatory mediators such as cytokines and adhesion molecules. This reduces airway edema, mucus production, and eosinophil infiltration, thereby improving airflow and reducing asthma symptoms. The inhaled route delivers the drug directly to the site of inflammation while minimizing systemic exposure.","oneSentence":"Budesonide is a corticosteroid that reduces airway inflammation by binding to glucocorticoid receptors and suppressing inflammatory cytokine production.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:01:29.801Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance therapy"},{"name":"Chronic obstructive pulmonary disease (COPD)"}]},"trialDetails":[{"nctId":"NCT07073950","phase":"PHASE4","title":"A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation","status":"RECRUITING","sponsor":"AstraZeneca","startDate":"2025-11-24","conditions":"Chronic Obstructive Pulmonary Disease, Hyperinflation","enrollment":56},{"nctId":"NCT06067828","phase":"PHASE3","title":"A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD).","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-10-24","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":171},{"nctId":"NCT06027606","phase":"PHASE1","title":"Cardiovascular Consequences of Inhaled Short-acting Beta-agonist Use","status":"COMPLETED","sponsor":"University of Alberta","startDate":"2023-09-01","conditions":"Healthy","enrollment":81},{"nctId":"NCT06245551","phase":"PHASE3","title":"A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2023-12-22","conditions":"Asthma, Exercise-Induced","enrollment":64},{"nctId":"NCT06657079","phase":"PHASE1, PHASE2","title":"A Combination of an Inhaled Budesonide and Ipratropium in Patients at Risk of Developing ARDS","status":"COMPLETED","sponsor":"Damanhour University","startDate":"2024-05-01","conditions":"ARDS, Prevention and Control","enrollment":119},{"nctId":"NCT00092092","phase":"PHASE4","title":"Study of Montelukast and Its Effect on Lower Leg Growth in Children With Asthma (MK-0476-254)","status":"COMPLETED","sponsor":"Organon and Co","startDate":"2002-10","conditions":"Asthma, Bronchial","enrollment":71},{"nctId":"NCT06105671","phase":"NA","title":"U-LABA/ICS Effects on Exercise Performance, Formoterol","status":"COMPLETED","sponsor":"Morten Hostrup, PhD","startDate":"2024-01-05","conditions":"Exercise Performance","enrollment":20},{"nctId":"NCT03615742","phase":"PHASE4","title":"Diesel Exhaust Induces Glucocorticoid Resistance","status":"RECRUITING","sponsor":"University of British Columbia","startDate":"2018-12-01","conditions":"Exposure to Pollution, Glucocorticoid Resistance","enrollment":30},{"nctId":"NCT01803555","phase":"PHASE3","title":"Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®","status":"COMPLETED","sponsor":"Teva Branded Pharmaceutical Products R&D, Inc.","startDate":"2013-07-04","conditions":"Asthma","enrollment":605},{"nctId":"NCT03847896","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered Dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma","status":"COMPLETED","sponsor":"Bond Avillion 2 Development LP","startDate":"2019-03-20","conditions":"Asthma","enrollment":1001},{"nctId":"NCT03015259","phase":"PHASE3","title":"Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients","status":"COMPLETED","sponsor":"Kindeva Drug Delivery","startDate":"2016-12-29","conditions":"Asthma","enrollment":1762},{"nctId":"NCT02227394","phase":"PHASE2","title":"Study to Compare the Effects of Z7200 And Symbicort® Turbohaler on Respiratory Imaging Parameters in Asthmatic Patients","status":"COMPLETED","sponsor":"Zambon SpA","startDate":"2014-08","conditions":"Asthma, Asthma Chronic, Asthma Bronchial","enrollment":20},{"nctId":"NCT04234464","phase":"PHASE3","title":"A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma","status":"COMPLETED","sponsor":"Bond Avillion 2 Development LP","startDate":"2020-01-15","conditions":"Exercise Induced Bronchospasm","enrollment":60},{"nctId":"NCT05055414","phase":"PHASE2","title":"Arformoterol/Budesonide for COVID-19","status":"UNKNOWN","sponsor":"Korea United Pharm. Inc.","startDate":"2021-11-01","conditions":"Coronavirus Infection","enrollment":140},{"nctId":"NCT03478696","phase":"PHASE4","title":"A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC /VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-06-25","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":732},{"nctId":"NCT03478683","phase":"PHASE4","title":"A Randomized Study, Comparing Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy, Versus Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2018-06-25","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":729},{"nctId":"NCT02991859","phase":"PHASE2","title":"Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-02-09","conditions":"Asthma","enrollment":56},{"nctId":"NCT02019758","phase":"PHASE4","title":"Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis","status":"COMPLETED","sponsor":"University of North Carolina, Chapel Hill","startDate":"2015-01-01","conditions":"Eosinophilic Esophagitis","enrollment":129},{"nctId":"NCT03175926","phase":"NA","title":"Description of the Ability to Learn How to Handle Inhaler Devices in Asthma","status":"WITHDRAWN","sponsor":"University Hospital, Bordeaux","startDate":"2017-12-01","conditions":"Asthma","enrollment":""},{"nctId":"NCT02533505","phase":"PHASE4","title":"Phase IV O2 Consumption Study in COPD Patients.","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2015-08-25","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":51},{"nctId":"NCT02345161","phase":"PHASE3","title":"A Comparison Study Between the Fixed Dose Triple Combination of Fluticasone Furoate/ Umeclidinium/ Vilanterol Trifenatate (FF/UMEC/VI) With Budesonide/Formoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-01-23","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1811},{"nctId":"NCT02157935","phase":"PHASE3","title":"Comparing the Efficacy of Symbicort® pMDI and Formoterol Turbuhaler in Reducing Exacerbations in Patients With Cronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"AstraZeneca","startDate":"2014-06-27","conditions":"COPD Patients","enrollment":2026},{"nctId":"NCT02105012","phase":"PHASE2","title":"Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2014-04-01","conditions":"Asthma","enrollment":147},{"nctId":"NCT02771717","phase":"PHASE4","title":"Low Exhaled NO and ICS in Suspected Asthma","status":"UNKNOWN","sponsor":"University of Nottingham","startDate":"2016-05","conditions":"Asthma","enrollment":165},{"nctId":"NCT02308098","phase":"PHASE3","title":"To Confirm Equivalent Bronchodilator Efficacy of the Test Product Compared to the Reference Product","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2014-12","conditions":"Asthma","enrollment":72},{"nctId":"NCT00483743","phase":"PHASE2","title":"Safety, Tolerability and PD Activity of Inhaled TPI 1020 Versus Inhaled Budesonide in COPD Patients","status":"COMPLETED","sponsor":"Syntara","startDate":"2007-11","conditions":"Copd Bronchitis","enrollment":62},{"nctId":"NCT00633919","phase":"PHASE2, PHASE3","title":"Efficacy of SLITone in House Dust Mite Allergic Patients","status":"COMPLETED","sponsor":"ALK-Abelló A/S","startDate":"2006-07","conditions":"Allergy","enrollment":124}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Placebo to budesonide inhaler","genericName":"Placebo to budesonide inhaler","companyName":"Organon and Co","companyId":"organon-and-co","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Budesonide is a corticosteroid that reduces airway inflammation by binding to glucocorticoid receptors and suppressing inflammatory cytokine production. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}