{"id":"ff-gw642444-inhalation-powder","safety":{"commonSideEffects":[{"rate":null,"effect":"Tremor"},{"rate":null,"effect":"Headache"},{"rate":null,"effect":"Palpitations"},{"rate":null,"effect":"Muscle cramps"},{"rate":null,"effect":"Dry mouth"}]},"_chembl":{"chemblId":"CHEMBL3975426","moleculeType":"Small molecule","molecularWeight":"488.64"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The formoterol component activates beta-2 adrenergic receptors to increase cAMP and cause bronchial smooth muscle relaxation. GW642444 blocks M3 muscarinic receptors to prevent acetylcholine-induced bronchoconstriction. Together, these complementary mechanisms provide sustained bronchodilation through dual pathways.","oneSentence":"FF/GW642444 is a dual bronchodilator combining a long-acting beta-2 agonist (formoterol fumarate) and a long-acting muscarinic antagonist (GW642444) to relax airway smooth muscle and improve airflow.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:12:28.504Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Chronic obstructive pulmonary disease (COPD)"},{"name":"Asthma (in combination with inhaled corticosteroid)"}]},"trialDetails":[{"nctId":"NCT03248128","phase":"PHASE3","title":"Safety and Efficacy Study of Fluticasone Furoate/Vilanterol (FF/VI) Fixed Dose Combination (FDC) Compared to FF Alone in Subjects With Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2017-10-20","conditions":"Asthma","enrollment":906},{"nctId":"NCT01706198","phase":"PHASE3","title":"An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-11-01","conditions":"Asthma","enrollment":4233},{"nctId":"NCT02446418","phase":"PHASE3","title":"A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2015-07-09","conditions":"Asthma","enrollment":423},{"nctId":"NCT01017952","phase":"PHASE3","title":"A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-09-25","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1635},{"nctId":"NCT01053988","phase":"PHASE3","title":"A 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-10-05","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1031},{"nctId":"NCT01323621","phase":"PHASE3","title":"Study Evaluating the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-03-18","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":512},{"nctId":"NCT01395888","phase":"PHASE3","title":"A Study to Compare the Impact of Fulticasone Furoate/Vilanterol vs. Tiotropium on Arterial Stiffness in COPD","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-06-30","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":260},{"nctId":"NCT01054885","phase":"PHASE3","title":"Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-10-19","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1226},{"nctId":"NCT01072149","phase":"PHASE3","title":"A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Profiles of 3 Doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the End of a 28-day Treatment Period in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Compared to Placebo","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-01-01","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":54},{"nctId":"NCT01009463","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2009-09-25","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":1626},{"nctId":"NCT01323634","phase":"PHASE3","title":"Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate (FF) /GW642444 (Vilanterol) (VI) Inhalation Powder 100/25mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2011-03-18","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":519},{"nctId":"NCT01691547","phase":"PHASE1","title":"A Study to Assess the Systemic Exposure, Systemic Pharmacodynamics and Safety and Tolerability of FluticasoneFuroate, Umeclidinium and Vilanterol in Healthy Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-12-17","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":44},{"nctId":"NCT01299558","phase":"PHASE1","title":"Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate and GW642444 Are Processed by the Body in Healthy Subjects","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-05-17","conditions":"Asthma","enrollment":16},{"nctId":"NCT01165125","phase":"PHASE1","title":"A Drug Interaction Study With Fluticasone Furoate/GW642444 Inhalation Powder and Ketoconazole","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-07-01","conditions":"Asthma","enrollment":18},{"nctId":"NCT01209026","phase":"PHASE1","title":"Corrected QT (QTc) Study With Flucticasone Furoate and GW642444","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-06-23","conditions":"Asthma","enrollment":85},{"nctId":"NCT01551758","phase":"PHASE3","title":"A Randomised Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Chronic Obstructive Pulmonary Disease (COPD)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-03-13","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":2802},{"nctId":"NCT01894386","phase":"PHASE1","title":"Pharmacokinetic Study in Healthy Volunteers to Characterise the Exposure of Fluticasone Furoate (FF), Vilanterol (VI) and Umeclidinium (UMEC) at Two Different Doses","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2013-07-15","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":48},{"nctId":"NCT01498679","phase":"PHASE3","title":"Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry.","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-01","conditions":"Asthma","enrollment":311},{"nctId":"NCT01086410","phase":"PHASE3","title":"Safety Study of the Effects of Inhaled Fluticasone Furoate/GW642444 on the Hypothalamic-Pituitary-Adrenal (HPA) Axis","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-03","conditions":"Asthma","enrollment":185},{"nctId":"NCT01192191","phase":"PHASE3","title":"A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-08","conditions":"Pulmonary Disease, Chronic Obstructive","enrollment":187},{"nctId":"NCT01244984","phase":"PHASE3","title":"A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 and FF in Japanese Subjects With Asthma","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2010-07","conditions":"Asthma","enrollment":243},{"nctId":"NCT01498653","phase":"PHASE3","title":"Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Trifenatate in the Treatment of Asthma in Adolescent and Adult Subjects of Asian Ancestry","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2012-01","conditions":"Asthma","enrollment":313}],"_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":["FF Inhalation Powder","Placebo","GW642444 Inhalation Powder"],"phase":"phase_3","status":"active","brandName":"FF/GW642444 Inhalation Powder","genericName":"FF/GW642444 Inhalation Powder","companyName":"GlaxoSmithKline","companyId":"gsk","modality":"Small molecule","firstApprovalDate":"","aiSummary":"FF/GW642444 is a dual bronchodilator combining a long-acting beta-2 agonist (formoterol fumarate) and a long-acting muscarinic antagonist (GW642444) to relax airway smooth muscle and improve airflow. Used for Chronic obstructive pulmonary disease (COPD), Asthma (in combination with inhaled corticosteroid).","enrichmentLevel":3,"visitCount":1,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}