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Protocol Summaries: fluticasone propionate/salmeterol

Protocol Summaries for fluticasone propionate/salmeterol
GSK
Study 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
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 Safety and Efficacy of ADVAIR DISKUS 250/50mcg Plus SPIRIVA HANDIHALER Versus SPIRIVA HANDIHALER Plus Placebo DISKUS in Subjects with Chronic Obstructive Pulmonary Disease (COPD). SPIRIVA and HANDIHALER are trade marks of Boehringer Ingelheim 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
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. Not yet recruiting
112605 Phase 4 Outcomes for Medicare asthma patients taking fluticasone propionate/salmeterol combination versus Inhaled Corticosteroid (ICS) or other combination therapy Completed
112606 Phase 4 Risk of Emergency Department or Inpatient Readmission Among Asthma Patients with An Initial Event Not yet recruiting
112607 Phase 4 Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients Not yet recruiting
112608 Phase 4 Outcomes Study of the Use of Fluticasone Propionate in Pediatric Asthmatics Completed
112609 Phase 4 Assessment of COPD-related Outcomes Post Hospitalization in a managed care setting. Completed
112646 Phase 4 Advair versus other initial maintenance therapies (IMT) in an elderly COPD population 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
113244 Phase 4 Prospective, parallel-group, randomized study to evaluate the compliance to the treatment of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the association Fluticasone 250 mcg/dose and Salmeterol 50 mcg/dose (Seretide) twice a day. ADERE PROJECT Completed
113553 EU-COAST STUDY: European cost of asthma treatment economic impact of asthma control Recruiting
113865 phase 4 Advair Adherence in Patients with Chronic Obstructive Pulmonary Disease 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. Active not recruiting
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 Recruiting
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 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
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
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
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

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