Home > Protocol Summaries: Compounds > fluticasone propionate/salmeterol Protocol Summaries: fluticasone propionate/salmeterol GSKStudy ID Phase Title Status 100614 phase 4 SUccessful Control and Clinical Effectiveness of SERETIDE study in aSthma, a randomised controlled study to investigate the clinical effectiveness and health outcome of SERETIDE in patients with moderate and severe persistent asthma in Korea Completed 102318 phase 4 Steroid-sparing management of the salmeterol/fluticasone 50/100µg b.i.d. combination compared to fluticasone 200µg b.i.d. in children and adolescents with moderate asthma Completed 102970 phase 3 HZC102970: 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 108835 phase 4 An Open Label, Multicentre Study to Evaluate Patient Satisfaction with Fluticasone/Salmeterol HFA MDI with Counter in Adult Subjects (18 years of age and older) with Asthma or COPD. Completed 109315 phase 4 A Retrospective Study of Healthcare Utilization and Costs of Step-Down Therapy in Asthma Patients Receiving Fluticasone Propionate/Salmeterol Combination Completed 109780 phase 4 Follow-up survey to compare stable dosing (SERETIDE) with SYMBICORT SMART, maintenance and reliever therapy in one inhaler in moderate and severe asthmatics. Completed 110099 Phase 3 A study to compare GW815SF HFA MDI with concomitant treatment with salmeterol xinafoate DPI plus fluticasone propionate DPI and to assess long-term safety of GW815SF HFA MDI Completed 110101 Phase 3 Clinical assessment of GW815SF HFA MDI in pediatric patients with bronchial asthma -A long term (24-week) study- Completed 111114 phase 4 A 24-Week Study to Evaluate the Efficacy and Safety of ADVAIR DISKUS (Fluticasone Propionate/Salmeterol Combination Product 250/50mcg Inhalation Powder) BID Plus Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder 18mcg) QD Versus Spiriva QD Plus Placebo DISKUS BID Completed 111116 phase 4 Prevalence of Chronic Airway Onstruction in a Subject Population with a History of Cigarette Smoking in a Primary care Setting Completed 111117 phase 4 A Randomized, Double-Blind, Double-Dummy, Parallel Group 12-Week Comparison of the Efficacy and Safety of Fluticasone Propionate/Salmeterol Hydrofluoroalkane 134a Metered-Dose-Inhaler 230/42mcg twice-daily with Fluticasone Propionate/Salmeterol DISKUS 250/50mcg twice-daily in subjects with COPD Completed 111266 phase 4 Impact of initiating tiotropium alone versus initiating tiotropium in combination with fluticasone propionate/salmeterol xinafoate combination (FSC) on Chronic Obstructive Pulmonary Disease-related outcomes in patients with pre-existing exacerbations Completed 111267 phase 4 Outcomes from Initial Maintenance Therapy With Fluticasone Propionate 250/Salmeterol 50 (FSC) or Tiotropium in Chronic Obstructive Pulmonary Disease Completed 112277 phase 4 Drug Use Investigation for ADOAIR (fluticasone/salmeterol) Completed 112278 phase 4 Special Drug Use Investigation for ADOAIR (fluticasone/salmeterol) Active not recruiting 112355 phase 4 A Randomized, Double-Blind, Parallel-Group, 16-Week Study to Evaluate the Effect of Fluticasone Propionate/Salmeterol DISKUS® 250/50mcg BID and Placebo on Arterial Stiffness in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Completed 112604 phase 4 Comparison of Healthcare Utilization and Costs in Patients with Asthma who Fluticasone/Salmeterol Inhalation Powder versus other Inhaled Corticosteroid(s) in Typical Clinical Practice Using Health Insurance Claims Data. Completed 112605 phase 4 Outcomes for Medicare asthma patients taking fluticasone propionate/salmeterol xinafoate combination versus Inhaled Corticosteroids or other combination therapy Completed 112606 phase 4 Use of Fluticasone Propionate/Salmeterol Combination Post Emergency Department Visit Completed 112607 phase 4 Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients Completed 112608 phase 4 Comparison of Asthma-related Outcomes and Costs in Pediatric Subjects that Received Fluticasone Propionate, Budesonide or Montelukast in a Large Managed Care Population Completed 112609 phase 4 Chronic Obstructive Pulmonary Disease (COPD)-Related Healthcare Utilization and Costs After Discharge From a Hospitalization or Emergency Department Visit on a Regimen of Fluticasone Propionate–Salmeterol Combination Versus Other Maintenance Therapies Completed 112646 phase 4 Outcomes and Costs Associated with initiating Maintenance Treatment with Fluticasone Propionate 250mcg/Salmeterol xinafoate 50mcg Combination (FSC) Versus Anticholinergics including Tiotropium (TIO) in Patients with Chronic Obstructive Pulmonary Disease (COPD) Completed 112708 Phase 4 Control of Asthma With Addition of Long-Acting Beta-Agonists to Inhaled Corticosteroid Regimens Systematic Review A Meta-analysis of Observational Studies Completed 112989 phase 4 Validation of a New Shortness of Breath with Daily Activities Questionnaire in patients with Chronic Obstructive Pulmonary Disease Completed 113095 phase 4 Special Drug Use Investigation for ADOAIR DISKUS COPD Active not recruiting 113865 phase 4 Fluticasone propionate-salmeterol combination adherence in Patients with Chronic Obstructive Pulmonary Disease (COPD) Completed 113872 phase 4 A Randomized, Double-Blind, Parallel Group study of ADVAIR™ DISKUS™ 100/50 and FLOVENT™DISKUS™ 100, both twice daily, in a Pediatric Population during the Fall Viral Season. Completed 113874 phase 4 A Randomized, Double-Blind, Parallel Group, Multicenter Study of the Effects of Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID (ADVAIR DISKUS™) in Comparison to Salmeterol 50mcg BID (SEREVENT DISKUS™) on the Rate of Exacerbations of COPD Following Hospitalization Completed 113877 phase 4 A study of fluticasone propionate/salmeterol DISKUS combination product 250/50 mcg twice daily plus tiotropium 18 mcg daily versus placebo DISKUS twice daily plus tiotropium 18 mcg daily on exercise time and physiological parameters in subjects with Chronic Obstructive Pulmonary Disease Completed 113898 phase 4 Outcomes Associated with Early or Delayed Maintenance Treatment Post-Chronic Obstructive Pulmonary Disease Exacerbation Completed 113899 phase 4 Differences in the risk of re-hospitalization and other COPD-related (Chronic Obstructive Pulmonary Disease) exacerbations and costs for patients receiving fluticasone propionate-salmeterol xinafoate combination 250/50mcg (FSC) versus anticholinergics [i.e. tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (IPR) post-hospitalization or ED visit for the treatment of COPD. Completed 113900 phase 4 Clinical and Economic Burden of Patients with Chronic Obstructive Pulmonary Disease in a Medicaid Population Completed 113901 phase 4 Outcomes for Chronic Obstructive Pulmonary Disease moderate exacerbators initiating treatment Completed 113902 phase 4 Chronic Obstructive Pulmonary Disease (COPD)-Related Outcomes and Costs for Patients on Combination Fluticasone Propionate-Salmeterol Xinafoate 250/50mcg versus Anticholinergics in a Comorbid COPD-Depression/Anxiety Population Completed 113903 phase 4 Observed outcomes associated with fluticasone propionate/salmeterol xinafoate or inhaled corticosteroids in asthma patients Completed 114334 phase 2 A comparative bioavailability study to compare the pharmacokinetic (PK)and pharmacodynamic (PD) effects of Fluticasone propionate and Salmeterol delivered by Fluticasone propionate/ Salmeterol combination in a capsule-based inhaler and a multi-dose dry powder inhaler, in moderate asthma patients and moderate to severe COPD patients. Completed 114937 Burden of Frequent and Infrequent Exacerbating Patients with Chronic Obstructive Pulmonary Disease (COPD) Active not recruiting 114940 n\a USHO-11-3281: Predictors of stepping down asthma therapy: observational study and Fluticasone propionate-Salmeterol Combination Therapy outcomes study Active not recruiting 114941 Assessment of asthma-related resources after initiation of an inhaled corticosteroid switch: Observational study Active not recruiting 115358 phase 4 A 6-month safety and benefit study of inhaled fluticasone propionate/ salmeterol combination versus inhaled fluticasone propionate in the treatment of 6,200 pediatric subjects 4-11 years old with persistent asthma Recruiting 115359 phase 4 SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects with Asthma Recruiting 116516 Community based patient questionnaire survey to assess asthma control in 4 Indian cities Not yet recruiting 116717 phase 4 Evaluating the control of COPD symptoms in patients treated with tiotropium bromide 18mcg once daily alone, ADOAIR 50/250mcg twice daily alone or ADOAIR 50/250mcg plus tiotropium bromide 18mcg Recruiting ACE104325 phase 4 A randomized, open label comparative study to determine the proportion of asthma patients on SERETIDE Diskus 50/250 mcg b.i.d. achieving Total Control when given medication and compliance enhancement training compared to those receiving medication only. Completed ADA103575 phase 4 See Detailed Description Completed ADA103578 Phase 4 See Detailed Description Completed ADA109055 phase 4 A 52-week, Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP) DISKUS 250 mcg BID in Treatment of Subjects with Asthma Completed ADA109057 phase 4 A 52-week, Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP) DISKUS 250 mcg BID in Treatment of Subjects with Asthma Completed ADC105931 Phase 4 A Randomized, Double-Blind, Parallel-Group, 12-Week Study to Evaluate the Anti-Inflammatory Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID Compared with Salmeterol DISKUS 50mcg BID in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Terminated HZA109895 Phase 4 An exploratory study to evaluate the response of salmeterol plus fluticasone propionate vs fluticasone propionate alone to experimental nasal inoculation with rhinovirus Terminated HZA109912 Phase 4 See Detailed Description Completed SAM 106538 Phase 4 Reaching Asthma control with Salmeterol/Fluticasone 50/250 µg bd combination in steroid naive or low dose inhaled corticoid steroid patients by using asthma control test (ACT) comparison of patient self rating with diary card data. Completed SAM101667 phase 4 See Detailed Description Completed SAM103848 phase 3 See Detailed Description Completed SAM103976 phase 4 SERETIDE vs FLIXOTIDE in mild persistent asthma (GINAII) Completed SAM104926 phase 4 See Detailed Description Completed SAM108037 Phase 4 See Detailed Description Terminated SAM109352 Phase 4 Rationale for therapy with low dose steroids combined with long-acting beta2-agonists in patients with allergic asthma: redirecting innate immune responses by long-term treatment with high doses of inhaled steroids Terminated SAM40056 phase 4 See Detailed Description Completed SAM40065 phase 4 A multicenter, randomized, double-blind, parallel group, 40-week comparison of asthma control using bronchial hyperresponsiveness as an additional guide to long-term treatment in adolescents and adults receiving either fluticasone propionate/salmeterol DISKUSTM BID or fluticasone propionate DISK ... Completed SAM40086 phase 4 A multicenter, randomized, double-blind, parallel group, 40-week comparison of asthma control using bronchial hyperresponsiveness as an additional guide to long-term treatment in adolescents and adults receiving either fluticasone propionate/salmeterol DISKUSTM BID or fluticasone propionate DISK ... Completed SAM40100 Phase 4 Comparator study to demonstrate superiority of salmeterol/fluticasone propionate 50/100mcg bd over fluticasone propionate 200mcg bd with respect to airway physiology in children treated for 6 weeks. Completed SAM40104 Phase 4 See Detailed Description Completed SAM49071 Phase 4 See Detailed Description Completed SAS10019 Phase 1 A repeat dose, randomised, double blind, 2-way crossover study to assess the safety and systemic exposure of SERETIDE/VIANI 50/50 COA compared to concurrent administration of individual Fluticasone Propionate 50 and Salmeterol 50 DISKUS inhalers in subjects aged 18 - 55 years with mild asthma Completed SAS104449 Phase 2 See Detailed Description Completed SAS105519 phase 4 See Detailed Description Completed SAS107541 phase 4 A long term follow up study for a comparison of stepwise treatment of asthmatic children with Salmeterol/Fluticasone propionate combination product (SERETIDE®) and/or Fluticasone propionate (FLIXOTIDE (TM)) based on PD20 methacholine and symptoms or based on symptoms only. Completed SAS30018 Phase 3 Comparison of stepwise treatment of asthmatic children with Salmeterol/Fluticasone propionate combination product (Seretide®) and/or Fluticasone propionate (Flixotide®) based on PD20 methacholine and symptoms or based on symptoms only (Children Asthma Therapy Optimal) Completed SAS30021 phase 3 A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic ... Completed SCO100250 phase 4 See Detailed Description Completed SCO100646 phase 3 See Detailed Description Completed SCO104925 phase 4 See Detailed Description Completed SCO104962 Phase 2 See Detailed Description Completed SCO105782 Phase 3 A randomized, double-blind, parallel-group study of fluticasone propionate/salmeterol combination (FSC 250/50mcg) twice daily and salmeterol (SAL 50mcg) twice daily to validate a new shortness of breath questionnaire in patients with chronic obstructive pulmonary disease (COPD) Terminated SCO107227 phase 4 A 12 month open-label randomized parallel group study to investigate the influence of salmeterol xinafoate/fluticasone propionate either in fixed combination or separately via Diskus inhalers on the course of the disease and frequency of exacerbations in subjects with severe and very severe COPD. Completed SCO30003 phase 3 See Detailed Description Completed SCO30005 Phase 3 A 13-week, double-blind, parallel group, multi-centre study to compare the bronchial anti-inflammatory activity of the combination of salmeterol/fluticasone propionate 50/500mcg twice daily compared with placebo twice daily in patients with Chronic Obstructive Pulmonary Disease (COPD) Completed SCO40036 phase 4 See Detailed Description Completed SCO40041 Phase 4 A Randomized, Double-Blind, Parallel-Group Clinical Trial Evaluating the Effect of the fluticasone propionate/salmeterol Combination Product 250/50mcg BID via DISKUS versus salmeterol 50mcg BID via DISKUS on Bone Mineral Density in Subjects with Chronic Obstructive Pulmonary Disease (COPD) Completed SCO40043 phase 4 See Detailed Description Completed SCO40055 phase 3 See Detailed Description Completed SFA100062 phase 4 See Detailed Description Completed SFA100314 phase 4 A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects with Activity-Induced Bronchospasm Completed SFA100316 phase 4 A Stratified, Multicenter, Randomized, Double-Blind, Parallel Group, 4-Week Comparison of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID versus Fluticasone Propionate DISKUS 100mcg BID in Pediatric and Adolescent Subjects with Activity-Induced Bronchospasm Completed SFA103153 phase 4 A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone Completed SFA106484 phase 3 A randomized, double-blind, parallel group study evaluating the safety of fluticasone propionate/salmeterol 100/50mcg HFA (2 inhalations of 50/25mcg) twice daily compared with fluticasone propionate 100mcg HFA (2 inhalations of 50mcg) twice daily in subjects 4-11 years of age with persistent asthma Completed
