{"id":"ff-mdi-pt005","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Oral candidiasis"},{"rate":null,"effect":"Nervousness"}]},"_chembl":{"chemblId":"CHEMBL3975426","moleculeType":"Small molecule","molecularWeight":"488.64"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The fluticasone propionate component reduces airway inflammation by binding to glucocorticoid receptors, while formoterol acts as a long-acting beta-2 agonist to relax bronchial smooth muscle and improve airflow. This dual mechanism provides both anti-inflammatory and bronchodilatory effects in a single inhaled formulation.","oneSentence":"FF MDI is a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-2 agonist (formoterol) metered-dose inhaler for maintenance treatment of asthma and COPD.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:29.897Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Asthma maintenance treatment"},{"name":"Chronic obstructive pulmonary disease (COPD) maintenance treatment"}]},"trialDetails":[{"nctId":"NCT02727660","phase":"PHASE3","title":"A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2016-04-29","conditions":"Chronic Obstructive Pulmonary Disorder","enrollment":1876},{"nctId":"NCT02766608","phase":"PHASE3","title":"Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2016-05-31","conditions":"Chronic Obstructive Pulmonary Disorder","enrollment":2389},{"nctId":"NCT02937584","phase":"PHASE3","title":"A Study to Assess the Effects of PT001 and PT005 MDI on Specific Image Based Parameters in Subjects With Moderate to Severe COPD","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2016-12-29","conditions":"COPD, Chronic Obstructive Pulmonary Disease","enrollment":23},{"nctId":"NCT02343458","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2015-03-30","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":1756},{"nctId":"NCT02196077","phase":"PHASE2","title":"Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2014-08-01","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":180},{"nctId":"NCT01854645","phase":"PHASE3","title":"Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2013-05","conditions":"Chronic Obstructive Pulmonary Disease","enrollment":2103},{"nctId":"NCT01854658","phase":"PHASE3","title":"Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2013-07","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":1615},{"nctId":"NCT01970878","phase":"PHASE3","title":"Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)","status":"COMPLETED","sponsor":"Pearl Therapeutics, Inc.","startDate":"2013-11","conditions":"Chronic Obstructive Pulmonary Disease (COPD)","enrollment":892}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol","formoterol fumarate metered dose inhaler (FF MDI)"],"phase":"phase_3","status":"active","brandName":"FF MDI (PT005)","genericName":"FF MDI (PT005)","companyName":"Pearl Therapeutics, Inc.","companyId":"pearl-therapeutics-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FF MDI is a combination inhaled corticosteroid (fluticasone propionate) and long-acting beta-2 agonist (formoterol) metered-dose inhaler for maintenance treatment of asthma and COPD. Used for Asthma maintenance treatment, Chronic obstructive pulmonary disease (COPD) maintenance treatment.","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}