{"id":"chf-5993-100-6-12-5-g","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Dysphonia"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The formulation combines beclomethasone dipropionate (ICS) to suppress airway inflammation, formoterol (LABA) to provide rapid and sustained bronchodilation via beta-2 receptor agonism, and glycopyrronium (LAMA) to provide additional bronchodilation through muscarinic receptor antagonism. This triple therapy addresses multiple pathophysiologic mechanisms in obstructive airway disease, providing anti-inflammatory and dual bronchodilatory effects in a single inhaled device.","oneSentence":"CHF 5993 is a triple-combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist that reduces airway inflammation and improves bronchodilation through multiple pathways.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:56.988Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic obstructive pulmonary disease (COPD) maintenance therapy"},{"name":"Asthma maintenance therapy (potential)"}]},"trialDetails":[{"nctId":"NCT05898984","phase":"PHASE1","title":"Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2023-04-24","conditions":"Asthma","enrollment":69},{"nctId":"NCT03859414","phase":"PHASE1","title":"PK of BDP/FF/GB Single-inhaler Triple Therapy in Japanese vs. Caucasians","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2019-03-18","conditions":"Asthma, Chronic Obstructive Pulmonary Disease","enrollment":32},{"nctId":"NCT02676076","phase":"PHASE3","title":"TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-02-17","conditions":"Asthma","enrollment":1153},{"nctId":"NCT03197818","phase":"PHASE3","title":"Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-12-14","conditions":"COPD (Chronic Obstructive Pulmonary Disease)","enrollment":990}],"_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":"phase_3","status":"active","brandName":"CHF 5993 100/6/12.5 µg","genericName":"CHF 5993 100/6/12.5 µg","companyName":"Chiesi Farmaceutici S.p.A.","companyId":"chiesi-farmaceutici-s-p-a","modality":"Small molecule","firstApprovalDate":"","aiSummary":"CHF 5993 is a triple-combination inhaled corticosteroid/long-acting beta-2 agonist/long-acting muscarinic antagonist that reduces airway inflammation and improves bronchodilation through multiple pathways. Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy, Asthma maintenance therapy (potential).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}