{"id":"chf-5993-200-6-12-5-g","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Cough"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The formulation delivers beclomethasone (ICS), formoterol (LABA), and glycopyrronium (LAMA) in a single inhaler. The LABA and LAMA work synergistically to relax airway smooth muscle through different mechanisms, while the ICS reduces airway inflammation. This triple therapy addresses multiple pathophysiological mechanisms in COPD to improve lung function and reduce exacerbations.","oneSentence":"CHF 5993 is a triple-combination inhaled therapy that combines a long-acting beta-2 agonist, long-acting muscarinic antagonist, and inhaled corticosteroid to improve airway function and reduce inflammation in chronic obstructive pulmonary disease.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T00:44:56.985Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic obstructive pulmonary disease (COPD) maintenance therapy"}]},"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":"NCT02676089","phase":"PHASE3","title":"TRIple in Asthma hiGh strenGth vErsus Ics/Laba hs and tiotRopium (TRIGGER)","status":"COMPLETED","sponsor":"Chiesi Farmaceutici S.p.A.","startDate":"2016-04-06","conditions":"Asthma","enrollment":1433},{"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 200/6/12.5 µg","genericName":"CHF 5993 200/6/12.5 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 therapy that combines a long-acting beta-2 agonist, long-acting muscarinic antagonist, and inhaled corticosteroid to improve airway function and reduce inflammation in chronic obstructive pulmonary disease. Used for Chronic obstructive pulmonary disease (COPD) maintenance therapy.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}