Home > Protocol Summaries: Compounds > fluticasone furoate Protocol Summaries: fluticasone furoate GSKStudy ID Phase Title Status 102871 phase 3 HZC102871: A 52-week efficacy and safety study to compare the effect of three dosage strengths of Fluticasone Furoate/GW642444 Inhalation Powder with GW642444 on the Annual Rate of Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Completed 102932 phase 1 An open-label, randomised, 3-way crossover single dose study to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) when administered as FF/VI inhalation powder from the novel dry powder inhaler in healthy subjects. Completed 102936 phase 1 A randomised, placebo-controlled, four-way crossover repeat dose study to evaluate the effect of the inhaled fluticasone furoate (FF)/GW642444M combination on electrocardiographic parameters, with moxifloxacin as a positive control, in healthy subjects Completed 102942 phase 2 A randomized, double-blind, placebo-controlled, two-way crossover 14-day study to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of repeat dose inhaled fluticasone furoate 100ug (micrograms) in children aged 5-11 years with persistent asthma Completed 106847 phase 3 A Randomized, Double-Blind, Double-Dummy, Crossover Comparison of Fluticasone Furoate/Vilanterol 100/25 mcg Once Daily Versus Fluticasone Propionate 250 mcg Twice Daily in Asthmatic Adolescent and Adult Subjects with Exercise-Induced Bronchoconstriction Not yet recruiting 106855 phase 2 A dose-ranging study of fluticasone furoate (FF) inhalation powder in children aged 5-11 years with asthma Recruiting 111789 phase 2 An open-label, non-randomized, pharmacokinetic and safety study of repeat doses of fluticasone furoate and GW642444M combination in healthy subjects and in subjects with mild, moderate or severe hepatic impairment Completed 112018 phase 1 Phase I study of GW685698X-A randomized, double blind, placebo controlled, parallel-group, repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose from a novel dry powder device in healthy Japanese male subjects. Completed 112059 phase 3 A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents. Completed 112185 phase 4 A phase-IV, open-label study to evaluate safety/tolerability of once-daily AVAMYS (TM) aqueous nasal spray 110mcg among Vietnamese adult patients with established perennial allergic rhinitis (PAR) Completed 112202 phase 2 A Multi-Centre, Randomized, Double Blind Cross-over study to assess the non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients with Asthma Completed 112206 phase 3 A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared with Placebo in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Completed 112207 phase 3 A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared with Placebo in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Completed 112602 phase 4 Prospective Observational Study of Concomitant Allergic Rhinitis Treatment Patterns among Patients Starting on Fluticasone Furoate Nasal Spray in a Retail Pharmacy Setting Terminated 112777 phase 2 A randomized, double-blind, repeat dose, two period crossover study to evaluate the safety and tolerability, pharmacokinetics, and pharmacodynamics of inhaled fluticasone furoate/vilanterol 100/25 micrograms in children aged 5 to 11 years with persistent asthma Completed 113107 phase 3 A 12-week study to evaluate the 24 hour pulmonary function of Fluticasone Furoate (FF)/Vilanterol Inhalation Powder (FF/VI Inhalation Powder) once daily compared with Salmeterol/Fluticasone Propionate (FP) Inhalation Powder twice daily in subjects with Chronic Obstructive Pulmonary Disease (COPD) Completed 113108 phase 3 A 24-week study to evaluate the effect of fluticasone furoate/vilanterol 100/25 mcg Inhalation Powder delivered once-daily via a Novel Dry Powder Inhaler on arterial stiffness compared with placebo and vilanterol in subjects with Chronic Obstructive Pulmonary Disease (COPD). Recruiting 113109 phase 3 A 12-Week 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 Completed 113203 phase 2 A randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray 110 mcg in the treatment in the treatment of uncomplicated acute rhinosinusitis in adults and adolescents >= 12 years of age Completed 113342 phase 3 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Fluticasone Furoate Nasal Spray for 2 Weeks in Chinese Adult and Adolescent subjects with Allergic Rhinitis Completed 113406 Special Drug Use Investigation for ALLERMIST (Long term) Active not recruiting 113407 phase 4 Drug Use Investigation for ALLERMIST Completed 113477 phase 1 An open-label, randomised, two-way crossover study, to evaluate and compare the pharmacokinetics of fluticasone furoate, administered from a novel dry powder device (repeat dose) and intravenously (single dose), in healthy Caucasian, Japanese, Korean and Chinese subjects Completed 113596 phase 4 An open label, multi-centre, non-interventional post-marketing surveillance (PMS) to monitor the safety and effectiveness of Avamys® administered in Korean patients according to the prescribing information Recruiting 113684 phase 3 A 24-week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder Delivered Once Daily via a Dry Powder Inhaler Compared with Placebo in Subjects of Asian Ancestry with Chronic Obstructive Pulmonary Disease Active not recruiting 113714 phase 3 A randomised, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily compared to fluticasone propionate delivered twice daily in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with high-strength inhaled corticosteroids or mid-strength ICS/LABA combination therapy. Completed 113719 phase 3 A randomised, double-blind, placebo-controlled, parallel group, multicentre study to evaluate the efficacy and safety of fluticasone furoate/vilanterol trifenatate (FF/VI) inhalation powder delivered once daily for 12 weeks in the treatment of asthma in adolescent and adult subjects of Asian ancestry currently treated with low to mid-strength inhaled corticosteroid or low-strength combination therapy. Active not recruiting 114496 phase 3 A randomised, double-blind, multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents currently receiving mid to high strength inhaled corticosteroids. Completed 114624 phase 2 A randomised, repeat-dose, placebo-controlled, double-blind study to evaluate and compare the efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder, when administered either in the morning or in the evening, in male and female asthmaticsubjects Completed 114812 phase 4 A comparison of patients on AVAMYS ® versus NASONEX (A trade mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures Completed 115058 Assessment of Comorbidities in Chronic Obstructive Pulmonary Disease (COPD) in European Symptomatic Subjects from primary care Recruiting 115199 phase 1 A randomized, double-blind, placebo-controlled, four-way crossover study to evaluate and compare the pharmacodynamics and pharmacokinetics of fluticasone furoate /vilanterol in different dose combination (50/25mcg, 100/25mcg and 200/25mcg) after single and repeat dose administration from a novel dry powder device in healthy Chinese subjects Active not recruiting 115283 phase 3 A randomised, double-blind, placebo-controlled (with rescue medication), multi-centre study to evaluate the efficacy and safety of inhaled fluticasone furoate in the treatment of persistent asthma in adults and adolescents not currently receiving inhaled corticosteroids Completed 115285 phase 3 A randomised, double-blind, double-dummy, placebo controlled multi-centre study to evaluate the efficacy and safety of fluticasone furoate inhalation powder and fluticasone propionate inhalation powder in the treatment of asthma in adults and adolescents not currently treated with inhaled corticosteroids Completed 115440 phase 1 An open-label, randomised, replicate, six-way crossover, single dose study to determine the bioequivalence of fluticasone furoate (FF) inhalation powder (single strip configuration) compared with FF inhalation powder (two strip configuration) and compared with FF / vilanterol (VI) inhalation powder administered via the novel dry powder inhaler. Completed 115441 phase 1 An open label, part-randomised, four-way crossover, single and repeat dose study to determine the dose proportionality and absolute bioavailability of fluticasone furoate (FF) when administered as FF inhalation powder from the novel dry powder inhaler in healthy subjects Completed 116364 phase 3 Study FFR116364, a double-blind, placebo-controlled study of GW685698X in paediatric subjects with perennial allergic rhinitis Completed 116365 phase 3 Study FFR116365, an open-label study of GW685698X in paediatric subjects with perennial allergic rhinitis Completed 116592 phase 1 A randomized, double-blind, placebo-controlled cross-over study to determine the bronchodilator effect of a single dose of fluticasone furoate (FF)/ vilanterol (VI) 100/25 mcg combination administered in the morning in adult patients with asthma Not yet recruiting 116601 phase 3 A Randomised, Double-Blind, Placebo-Controlled, Cross-Over, Single-Centre Study to Investigate the Acute Lung Deflation Effects of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg Once Daily on Cardiac Biventricular Function and Arterial Stiffness in Adults with Chronic Obstructive Pulmonary Disease (COPD) Recruiting 116963 n\a PGx6304: Detailed evaluation of potential role of genetic variation within GLCCI1 and its influence on steroid response Completed 116974 phase 3 A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared with Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Active not recruiting 117156 phase 2 A randomised, repeat-dose, placebo-controlled, three-way crossover, double dummy study to evaluate and compare the efficacy of Fluticasone Furoate inhalation powder delivered via the single strip dry powder inhaler when administered either in the morning or in the evening, in male and female asthmatic subjects Recruiting FFA10013 phase 1 A study to investigate the pharmacokinetics of a single inhaled dose (400mcg) of GW685698X and its effect on serum cortisol in patients with impaired liver function and matched control subjects. Completed FFA106783 phase 2 See Detailed Description Completed FFA109684 phase 2 A Randomized Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group, Multicenter Dose Ranging Study to Evaluate the Efficacy and Safety of GW685698X Inhalation Powder Once Daily and Fluticasone Propionate Inhalation Powder 500mcg Twice Daily compared with Placebo for 8 Weeks in Adolescent an Completed FFA109685 phase 2 See Detailed Description Completed FFA109687 phase 2 See Detailed Description Completed FFA20001 phase 2 A randomised, double-blind, double dummy, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GW685698X 100mcg administered once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening all administered by inhalation via DISKHALER for 28 days in subjects with persistent bronchial asthma. Completed FFR100010 Phase 3 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 2 Weeks in Pediatric Subjects Ages 2 to <12 Years with Seasonal Allergic Rhinitis (SAR) Completed FFR100012 Phase 3 A randomized, double-blind, parallel group, placebo controlled, 6-week study of the effect of GW685698X aqueous nasal spray 100mcg QD on the hypothalamic pituitary adrenocortical (HPA) axis in children 2 to 11 years of age with perennial allergic rhinitis (PAR). Completed FFR100652 phase 3 Clinical Evaluation of GW685698 for Seasonal Allergic Rhinitis -A Placebo-controlled Study to Determine the Non-inferiority of GW685698 over Fluticasone Propionate Using a Double-blind Manner- Completed FFR100688 phase 3 Study of Perennial Allergic Rhinitis -Long term treatment study- Completed FFR101747 Phase 3 A Randomized, Double-blind, Placebo-controlled, 2-Week Crossover, Knemometric Assessment of the Effect of Once Daily GW685698X Aqueous Nasal Spray 100 mcg on Short Term Growth in Children Ages 6 - 11 Years with Seasonal and/or Perennial Allergic Rhinitis Completed FFR101782 phase 4 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Effects of a One-Year Course of Fluticasone Furoate Nasal Spray 110mcg QD on Growth in Pre-Pubescent, Pediatric Subjects with Perennial Allergic Rhinitis Completed FFR101816 Phase 3 See Detailed Description Completed FFR103184 Phase 3 A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Two Week Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100 mcg in Adult and Adolescent Subjects with Seasonal Allergic Rhinitis in Europe Completed FFR104503 Phase 3 See Detailed Description Completed FFR104861 Phase 3 See Detailed Description Completed FFR105693 phase 3 A Randomized, Single-Blind, Cross-Over, Multicenter Study to Validate the Preference Module of the Experience with Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Administered to Adult Subjects with Seasonal Allergic Rhinitis during a Three-week Cross-over Study Completed FFR106080 Phase 3 See Detailed Description Completed FFR110537 phase 4 A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, Two-Year Study to Evaluate the Ocular Safety of Once-Daily, Fluticasone Furoate Nasal Spray 110mcg in Adults and Adolescents 12 Years of Age and Older with Perennial Allergic Rhinitis Completed FFR111158 phase 2 A Pilot, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of Once-daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110 mcg for 4 Weeks in Adults and Adolescents with Irritant (Non-Allergic) Rhinitis Completed FFR20002 Phase 3 See Detailed Description Completed FFR30002 Phase 3 See Detailed Description Completed FFR30003 phase 3 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 14 days in Adult and Adolescent Subjects with Seasonal Allergic Rhinitis Completed FFR30006 phase 3 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor Rhinitis Completed FFR30007 phase 3 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor Rhinitis Completed FFR30008 phase 3 See Detailed Description Completed FFU105924 phase 4 A Randomized, Double-blind, Placebo-controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal SprayCharacteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate NasalSpray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal AllergicRhinitis Completed FFU105927 phase 4 A Randomized, Double-blind, Placebo-controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal SprayCharacteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate NasalSpray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis Completed FFU108556 Phase 3 A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Fluticasone Propionate Aqueous Nasal Spray in Subject with Allergic Rhinitis Completed FFU109045 Phase 4 A Comparison of Fluticasone Furoate Nasal Spray versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis Completed FFU109047 phase 4 A Comparison of Fluticasone Furoate Nasal Spray versus Oral Fexofenadine in the treatment of seasonal allergic rhinitis Completed FFU111439 phase 4 A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR) Completed HZA102928 phase 1 A randomised, double blind, placebo controlled, parallel group, 14 day repeat dose study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled GW685698X containing magnesium stearate in healthy subjects Completed HZA102940 phase 1 A randomised, double-blind, placebo-controlled, four-way crossover study to compare the pharmacodynamics and pharmacokinetics of GW685698X and GW642444M when administered separately and in combination as a single dose from a novel dry powder device in healthy japanese subjects Completed HZA105871 phase 1 A randomised, double-blind, placebo-controlled, four-waycrossover study to compare the pharmacodynamics andpharmacokinetics of GW685698X and GW642444M whenadministered separately and in combination as a single dose froma novel dry powder device in healthy subjects Completed HZA108799 phase 1 A randomised, double blind, two-way crossover study, to examine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single inhaled administration of GW685698X (800?g) with and without magnesium stearate, in mild/moderate asthmatic patients. Completed
