Fluticasone propionate/salmeterol xinafoate has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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Fluticasone propionate/salmeterol xinafoate Studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
100614 IV SUCCESS study: SUccessful Control and Clinical Effectiveness of Salmeterol/fluticasone propionate combination in asthma Study, a randomised controlled study to investigate the clinical effectiveness and health outcomes of salmeterol/fluticasone propionate combination in patients with moderate and severe persistent asthma in Korea.
105700 IV A Post-Marketing Surveillance to monitor the safety of SeretideTM (salmeterol-fluticasone propionate; SFC) administered in Korean subjects according to the prescribing information
FS12004 IV Seretide efficacy and safety monitoring in Slovenia
ADA103575 IV Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
ADA103578 IV Multicenter, Randomized, Double-Blind, Triple-Dummy, Placebo-Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving ADVAIR DISKUS® 100/50mcg BID or Placebo BID
ADC105931 IV 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)
ADC109043 IV An evaluation of the prevalence of airway obstruction consistent with chronic obstructive pulmonary disease (COPD) in subjects with a history of cigarette smoking and symptoms of chronic bronchitis in a primary care setting
ADERE ADULT IV A randomized, parallel group, open study to evaluate the impact of additional guidance provided by health care professionals on treatment compliance among asthmatic patients with persistent asthma (ADERE)
ADERE PEDIATRIC 1 IV Prospective, parallel-group, randomized, open label study to evaluate the impact of additional guidance from the health professionals team on treatment compliance of children aged between 6 and 14 years old with persistent moderate or severe asthma, receiving the combination salmeterol/fluticasone propionate 50/250 mcg (Seretide) twice a day. ADERE PROJECT (Pediatric)
EPIP181 IV A modified prescription-event monitoring study to assess the introduction of Seretide EvohalerTM into general practice in England
FAS40008 double blind period (1 year) IV An interventional three year study for asthma control - In what way and in what kind of population is it possible to get asthmatic patients free from symptoms, keep the patients in work, restore a normal lung function, diminish hyperreactivity and normalise quality of life?
FAS40008 whole study period (3 years) IV An interventional three year study for asthma control - In what way and in what kind of population is it possible to get asthmatic patients free from symptoms, keep the patients in work, restore a normal lung function, diminish hyperreactivity and normalise quality of life?
IND/SEREACC/PMS IV Post Marketing Surveillance (PMS) of salmeterol and fluticasone in fixed dose combination (Seretide® Accuhaler) in the Treatment of Bronchial Asthma.
SAM 30020 IV Efficacy and tolerability of the salmeterol/fluticasone 50/100 mcg combination Diskus, inhaled once daily in the evening, in comparison to the p.r.n. inhalation from the reproterol/sodium cromoglycate 0.5/ 1 mg combination MDI, as initial therapy for patients with mild asthma – a multicentre, randomised, open, parallel trial
SAM 3802 IV An observational study to assess the health related quality of life impact of treating poorly controlled asthmatic children with SeretideÔ 50/100mcg
SAM100456 IV Pilot study: A Single-Centre, Randomised, Open-Label, Cross Over Trial, Assessing Ease of use, Correctness of use and Patient Preference of Seretide (Salmeterol Xinafoate/Fluticasone Propionate Combination) via the Diskus versus Seretide via the Metered Dose Inhaler in Subjects at Least 55 Years of Age with Persistent Asthma or Chronic Obstructive Pulmonary Disease (COPD) Requiring Combination Therapy.
SAM101563/ SFCP4001 IV Tomodensitometric evaluation using multi-detector computerised tomography (MDCT) of bronchial and parenchymatous structures in asthmatic subjects before and after treatment with salmeterol/fluticasone propionate 50/250 Diskus one inhalation twice daily. Open-label, 3-month study
SAM104926 IV A multicentre, randomised, double-blind, double dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE™) at a dose of 50/100mg twice daily and fluticasone propionate (FLIXOTIDE™) at a dose of 200mg twice daily, both delivered via a dry powder inhaler (DISKUS™) for 12 weeks in asthma in children aged 4-11 years not controlled by inhaled corticosteroids alone at medium dose.
SAM30001 (SER9802 / SETET) IV Compliance in asthma and COPD treatment.
SAM30007 IV A multicentre, randomised, double-blind, controlled, parallel-group, comparative investigation of the corticosteroid-saving potential of the combination therapy fluticasone propionate and salmeterol (SERETIDE) compared with fluticasone propionate alone, given to adult asthmatic subjects, when reducing the inhaled corticosteroid dose from an initially high level of 500 mg bd.
SAM30010 IV A Randomized, Single-centre, Double-blind, Parallel-group Comparison of Seretide Accuhaler (50/250 µg Strength) bd with Fluticasone Accuhaler 250 µg bd in Subjects with Reversible Airways Obstruction
SAM30012 IV An open study to assess the efficacy and safety of Seretide DiskusÔ (salmeterol/fluticasone propionate 50/500mg strength) bd in subjects with reversible airways obstruction
SAM30022 IV A phase IV, multi-centre, double-blind, double-dummy, parallel group, randomised study comparing Seretide (25/50 2 puffs bd) via the Evohaler (MDI-HFA) with Beclometasone dipropionate (200mcg 2 puffs bd) via the MDI-CFC in adolescents and adults experiencing moderate symptoms of reversible airways obstruction.
SAM40004 IV A multi-centre, randomised, double-blind, placebo-controlled parallel group study to compare the effect on airway inflammation and remodelling of treatment with salmeterol/fluticasone propionate combination product (50/100mg strength) bd via the Accuhaler inhaler, or fluticasone propionate 100mg bd via the Accuhaler inhaler or placebo via the Accuhaler inhaler for 16 weeks, followed by double-blind treatment for 52 weeks with the salmeterol/fluticasone propionate combination product (50/100mg strength) bd via the Accuhaler inhaler or fluticasone propionate 100mg bd via the Accuhaler inhaler, in adults with reversible airways obstruction (SIRIAS - Seretide in Inflammation and Remodelling In Asthma Study)
SAM40008 IV A Multicentre, Randomised, Double-Blind, Parallel Group Comparison of the Efficacy of SERETIDE* bd and Fluticasone Propionate bd (Both Via DISKUS*/ACCUHALER*, Inhaler) when Tapering the Inhaled Corticosteroid Dose in Asthmatic Adults
SAM40010 IV A randomised, double blind, double-dummy, parallel-group, twelve week comparison of salmeterol/fluticasone propionate (FP) DISKUS/ACCUHALER 50/100mcg bd. with budesonide 200mcg bd. plus formoterol 4.5mcg bd. (both via breath-actuated dry powder inhaler [BADPI]) in Adult and Adolescent Asthmatics
SAM40012 IV A multicentre, randomised, double-blind, double-dummy, parallel group comparison of three treatments : 1) salmeterol/fluticasone propionate (SFC) (50/100mcg strength) bd via DISKUS/ACCUHALER inhaler, 2) fluticasone propionate 200mcg bd via DISKUS/ACCUHALER inhaler, 3) fluticasone propionate 100mcg bd via DISKUS/ACCUHALER inhaler in children aged 4-11 years with asthma
SAM40027 IV Gaining Optimal Asthma ControL (GOAL): A multi-centre, stratified, randomised, double-blind, parallel-group, step-up comparison of the level of asthma control achieved with salmeterol/fluticasone propionate combination DISKUS (ACCUHALER) dry powder inhaler compared with fluticasone propionate DISKUS (ACCUHALER) alone in adults and adolescents
SAM40030 IV A phase IV, multicentre, randomised, double blind, single dummy, parallel group study to compare the anti-inflammatory action of Seretide 50/100 bd via MDI with Flixotide 100mg bd via MDI plus montelukast 10mg od for 12 weeks in adults with mild to moderate asthma who are currently taking inhaled corticosteroids but have a requirement for further therapy
SAM40031 IV A 13 month, randomised, double-blind, parallel-group comparison of the efficacy of Seretide™ (fluticasone propionate/salmeterol combination Accuhaler™) and Flixotide™(fluticasone propionate Accuhaler™) when down-titrating the inhaled corticosteroid dose in asthmatic adults who have previously received Seretide™ 500/50 mg twice daily for at least 4 weeks.
SAM40032 IV A multi-centre, open label study to demonstrate the efficacy and tolerability of Seretide Accuhaler 50/100, 50/250 or 50/500mg twice daily after substituting for budesonide or beclomethasone dipropionate in doses of 500mg up to 2000mg daily in subjects with reversible airways obstruction.
SAM40034 IV A double-blind, randomised, parallel group, 12-week comparison of fluticasone propionate/salmeterol combination Diskus 100/50mcg BID with fluticasone propionate (FP) 250mcg BID as initial maintenance treatment in persistent asthma (Seretide Nordic Jump-Up Study)
SAM40036 IV A 12-week multicentre, randomised, double-blind, double-dummy, parallel group study to compare the efficacy and tolerability of once daily (QD) salmeterol/fluticasone propionate combination (salm/FP) 50/100mcg at night via the DISKUS/ACCUHALER with QD budesonide (BUD) 400mcg at night via a breath-actuated dry powder inhaler (BADPI) as initial maintenance therapy in mild-to-moderate asthmatic subjects
SAM40040 IV A twenty-four week, randomised, double-dummy, double-blind, parallel group study to compare the rate of asthma exacerbations between SERETIDE DISKUS 50/250mg 1 inhalation bd and formoterol/budesonide Breath-Actuated Dry Powder Inhaler (BADPI) 4.5/160mg 2 inhalations bd in subjects with moderate to severe asthma.
SAM40042 IV A double-blind, double-dummy, randomised, cross-over study to compare the bronchodilator effect of SERETIDE* ACCUHALER* 50/100mcg and formoterol/budesonide combination breath-actuated dry powder inhaler 6/200mcg in subjects with asthma following a single dose and after 4 weeks of regular treatment.
SAM40047 IV Duration of action of single inhalations of the salmeterol/ fluticasone combination product (50/250 µg) in comparison with the formoterol/ budesonide combination product (4.5/160 µg) in patients with moderate asthma - a randomised, double-blind, double-dummy, cross over study.
SAM40048 IV Randomised, double-blind, parallel group study on the efficacy and tolerability of the salmeterol 50 mcg / fluticasone 250 mcg combination Diskus compared to the formoterol 6 mcg / budesonide 200 mcg combination turbohaler administered twice daily in patients with moderate bronchial asthma.
SAM40049 (150905) IV A Danish, multi-centre, comparative, parallel-group study to determine whether initiation of combination treatment with Seretide™ (salmeterol + fluticasone propionate) 50/100 mg bd offers better asthma control than monotherapy with Flixotide™ (fluticasone propionate) 100 mg bd to adult asthmatic subjects uncontrolled on short-acting bronchodilator alone.
SAM40056 IV A randomised, double-blind, double-dummy, 52 week, parallel group study of a standard dosing regimen with salmeterol/fluticasone combination 50/250mcg bid (via the DISKUS/ACCUHALER inhaler) versus a symptom-driven, variable dosing regimen with formoterol/budesonide combination 6/200mcg (via a breath-actuated dry powder reservoir inhaler) in adult asthmatics.
SAM40058 IV A double-blind, randomised, parallel group study to evaluate the safety and tolerability of administering two inhalations b.i.d. (double dose) of the salmeterol/fluticasone propionate combination (SERETIDE) in subjects with asthma over two weeks.
SAM40062 IV A single-centre, single-dose, double-blind, double-dummy, placebo-controlled, randomised, three-way crossover study to compare the duration of action of SERETIDE* DISKUS* 50/100mcg versus formoterol/budesonide combination 4.5/160mcg Breath-Actuated Dry Powder Inhaler (BADPI) in subjects with asthma
SAM40065 IV 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 DISKUSTM BID (or placebo BID if asymptomatic)
SAM40066 IV A Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel Group, Four-Week Study Assessing the Efficacy of Fluticasone Propionate Aqueous Nasal Spray 200mcg QD versus Montelukast 10mg QD in Adolescent and Adult Subjects with Asthma and Seasonal Allergic Rhinitis Who are Receiving Concurrent Open-Label ADVAIR DISKUS 100/50mcg BID
SAM40067 IV A multicentre, randomized, open-label, parallel-group, six-week treatment study to evaluate the efficacy and safety of Seretide (Salmeterol/Fluticasone propionate combination product) 50/100 mg strength bd via Accuhaler™ inhaler vs Pulmicort Turbuhaler™ 400 mg bd in Chinese adults with asthma
SAM40086 IV 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 DISKUSTM BID (or placebo BID if asymptomatic)
SAM40090 IV A Twelve Week Multi-Centre, Randomized, Double-Blind, Parallel Group, Comparative Trial of Advair 50/100 mcg Diskus Inhalation Device BID versus Flovent 250 mcg Diskus Inhalation Device BID in Adolescents and Adults with Persistent Asthma (Program of Advair Control and Effectiveness – Advair Low Dose [PACE-ALD]
SAM40092 IV Effect of salmeterol/fluticasone propionate combination product on seasonal changes in airway responsiveness and exhaled nitric oxide in subjects with pollen-induced asthma.
SAM40100 IV Randomised, double-blind, comparator study to demonstrate the superiority of salmeterol/fluticasone propionate combination DISKUS™ 50/100mcg bd over fluticasone propionate DISKUS™/ACCUHALER™ 200mcg bd with respect to airway physiology in asthmatic children treated for 6 weeks.
SAM40101 IV A pilot single centre, randomized, double-blind crossover study to demonstrate the superiority of Salmeterol/fluticasone propionate combination product 50/100mcg bd versus fluticasone propionate 100mcg bd when treated for two weeks with respect to activity levels in children aged 7-15 years.
SAM40104 IV Single centre, randomised, double-blind, comparator study to demonstrate superiority of salmeterol/fluticasone propionate combination product 50/100mcg bd over fluticasone propionate 100mcg bd with respect to improvements in airway physiology in adults with persistent asthma treated for 4 weeks.
SAM40114 IV A post-marketing surveillance study on the real world use of SFC (Salmeterol /Fluticasone Propionate Combination) in Ireland
SAM40120 IV A phase IV, multi-centre, double-blind, parallel group, randomised study comparing Seretide (50/100mcg bd) via the Evohaler (MDI-HFA) with Flixotide (250mcg bd) via the Evohaler (MDI-HFA) in asthmatics with significant smoking history
SAM40121 IV Summary of the efficacy and safety and safety of salmeterol 50mcg and fluticasone propionate 100mcg administered in Diskus Dry Powder Inhaler twice daily in steroid experienced children with reversible airways obstruction
SAM49071 IV A multi-centre, randomised, double blind, stratified, parallel group study to evaluate whether a treatment strategy based on aiming for ‘Total control’ results in better airway hyper-responsiveness than a treatment strategy based on maintaining the treatment level at which ‘Well-controlled’ asthma was achieved
SAS 40030 IV A study to investigate switching from usual therapy to the salmeterol/ fluticasone (50/500 µg) combination DiskusŇ, followed by a reduction of inhaled steroid dosage in patients with moderate to severe asthma
SAS 40032 IV A randomised, parallel-group study of Viani (Salmeterol 50 mcg plus Fluticasone 250 mcg b.i.d.) inhaled from the Diskus® inhaler compared to Budesonide (800-1600 mcg) inhaled from Turbuhaler® plus a long-acting inhaled beta-2-agonist, in subjects with asthma
SAS105519 IV A repeat-dose, open-label, randomized, incomplete block design in pediatric subjects with asthma, ages 4 - 11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following Advair® HFA 45/21 mcg (2 inhalations), Advair HFA 45/21 mcg (2 inhalations) with Aerochamber Plus Spacer and Advair Diskus 100/50 twice daily
SAS20008 IV A 12 week open study to assess the efficacy and safety of Seretide Diskus 50/250mcg, 1 inhalation twice daily in patients with reversible airway obstruction compatible with the diagnosis of asthma.
SAS30013 IV A study to compare the long term effects on airway inflammation of Seretide versus Flixotide in adult subjects with asthma.
SAS30014/SER9803 IV A single-centre, double-blind, randomised, cross-over study to compare the short term effects on airway inflammation after allergen challenge of salmeterol/fluticasone propionate combination product (Seretide) versus fluticasone propionate (Flixotide) in adult subjects with asthma.
SAS30025 (protocol number : SEREBEL 01) IV Seretide for COntrol of REspiratory symptoms (SCORE): Switching inhaled steroids to Seretide in persistent asthma in general practice. An open label, sequential trial.
SAS40006 IV A Randomised, Double-Blind, Double-Dummy, Parallel-Group Comparison of Seretide DISKUS/ACCUHALER (50/250µg Strength) b.i.d. with Budesonide 800µg b.i.d. in Adolescents and Adults with Reversible Airways Obstruction
SAS40007 IV A Randomised, Double-Blind, Double-Dummy, Parallel-Group Comparison of SERETIDE DISKUS/ACCUHALER (50/100µg Strength) twice daily (bid) with Budesonide 400µg bid in Adolescents and Adults with Reversible Airways Obstruction
SAS40009 IV A multi-centre, randomised, double-blind, parallel group comparison of the salmeterol/ fluticasone propionate combination product (50/250µg) via Diskus twice daily versus fluticasone propionate (500µg) via Diskus twice daily in patients with moderate asthma (SAS 40009 local German study)
SAS40011 IV Efficacy and Safety of salmeterol/fluticasone propionate (VIANI®) 50/250µg twice daily via Diskus in patients with mild to moderate asthma
SAS40013 IV Can the serum level of eosinophil cationic protein (ECP) give directions for the choice between increasing the dose of fluticasone propionate or the addition of salmeterol in patients with symptomatic asthma?
SAS40014 (SER9801/SAFE) IV A multi-centre study examining the use of salmeterol xinafoate / fluticasone propionate via Diskus in relation to controlling asthma in moderate to severe patients: identifying risk factors contributing to an exacerbation of asthma and modification of treatment during exacerbations.
SAS40015 IV A multicentre, randomised, double-blind, double-dummy, parallel-group, 12-week, active control comparison of the salmeterol/fluticasone propionate combination product (50/100mcg strength) bd via the DISKUS/ACCUHALER inhaler with fluticasone propionate (100mcg strength) bd via the DISKUS/ACCUHALER inhaler plus oral montelukast 10mg od in adolescents and adults with reversible airways obstruction
SAS40018 IV A Multi-Center, Randomized, Double-Blind, Double Dummy, Parallel-Group, 12 Week Active Control Comparison of Salmeterol/Fluticasone Propionate Combination Product (50/100mcg BID) via the DISKUS inhaler with Fluticasone Propionate (100mcg BID) via the DISKUS plus Oral Montelukast (10mg QD) in Adults and Adolescents with Persistent Asthma Experiencing Symtoms on Inhaled Corticosteroid Therapy
SAS40019 (SER9806) IV A randomised, double blind, parallel group comparison of the effect of the salmeterol/fluticasone propionate combination product (50/250 mcg strength) bd via the Diskus inhaler with placebo bd via the Diskus inhaler in young adults who are in clinical remission of allergic asthma
SAS40020 IV A Randomized, Double-Blind, Double-Dummy, Parallel Group, 12-Week Comparative Trial of Salmeterol/Fluticasone Propionate Combination Product 50/100mcg BID Via the DISKUS Inhaler Versus Oral Montelukast 10mg QD in Adolescents and Adults with Persistent Asthma
SAS40021 IV A Randomized, Double-Blind, Double-Dummy, Parallel Group, 12-Week Comparative Trial of Salmeterol/Fluticasone Propionate Combination Product 50/100mcg BID Via the DISKUS Inhaler Versus Oral Montelukast 10mg QD in Adolescents and Adults with Persistent Asthma
SAS40023 IV A multi-centre, prospective study of Viani® 50/250µg twice daily via Diskus® in patients with mild to moderate asthma Viani and Diskus are registered trademarks of the GlaxoSmithKline group of companies.
SAS40024 IV A Randomized, Double-Blind, Parallel-Group Study Evaluating the Protective Effects of the Fluticasone Propionate/Salmeterol Combination Product (FSC, 100/50mcg BID via DISKUS) Against Bronchospasms Induced by Activity as Measured by Exercise Challenge Testing in Adolescent and Adult Subjects who Require Chronic Inhaled Corticosteroid Therapy for the Treatment of Persistent Asthma
SAS40025 IV A Randomized, Double-Blind, Parallel-Group Study Evaluating the Protective Effects of the Fluticasone Propionate/Salmeterol Combination Product (FSC 250/50mcg BID via DISKUS) Against Bronchospasms Induced by Activity as Measured by Exercise Challenge Testing in Adolescent and Adult Subjects who Require Chronic Inhaled Corticosteroid Therapy for the Treatment of Persistent Asthma
SAS40026 IV A randomized, double-blind, parallel group, comparative trial of fluticasone propionate/salmeterol combination product 100/50mcg DISKUS† inhaler BID versus fluticasone propionate 250mcg DISKUS inhaler BID in adolescents and adults with moderate persistent asthma.
SAS40027 IV A Randomized, Double-Blind, Parallel Group, Comparative Trial of Fluticasone Propionate/Salmeterol Combination Product 100/50mcg DISKUS Inhaler BID versus Fluticasone Propionate 250mcg DISKUS Inhaler BID in Adolescents and Adults with Moderate Persistent Asthma
SAS40028 IV An open-label, 12-week study to evaluate the effects of a corticosteroid-sparing dose of salmeterol/fluticasone propionate combination product 50/100mcg BID via the DISKUS inhaler on airway inflammation, airway remodeling, and bronchial hyperresponsiveness in adults with persistent asthma.
SAS40036 IV A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, 16-Week Comparison of Asthma Control in Adolescents and Adults Receiving Either Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID, Fluticasone Propionate DISKUS 100mcg BID, Salmeterol Xinafoate DISKUS 50mcg BID, or Oral Montelukast 10mg QD
SAS40037 IV A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, 16-Week Comparison of Asthma Control in Adolescents and Adults Receiving Either Fluticasone Propionate/Salmeterol DISKUS™ Combination Product 100/50mcg BID, Fluticasone Propionate DISKUS™ 100mcg BID, Salmeterol Xinafoate DISKUS™ 50mcg BID, or Oral Montelukast 10mg QD
SAS40039 IV Fluticasone propionate 250 µg plus salmeterol 50 µg (Seretide 50/250 µg bd) combined in a single inhaler (Diskus) in symptomatic patients with mild to moderate asthma previously not treated by maintenance therapy with inhaled corticosteroids and/or long acting beta agonists in adults and children above 12 years of age.
SAS40066 IV A Randomized, Open-Label, Crossover Pilot Trial, Assessing Patient Preference for ADVAIR DISKUS 100/50 BID (Fluticasone Propionate/Salmeterol Combination Product 100/50mcg) versus Singulair QD (Montelukast 10mg) in Subjects ł 15 years of age with Persistent Asthma.
SAS40067 IV Gaining asthma control with Seretide 50/500 in patients with moderate to severe persistent asthma in general practice.
SAS40068 IV A 24 week, multicentre, randomized, double-blind, parallel group trial to compare the efficacy and tolerability of salmeterol/fluticasone propionate (ADVAIRŇ) DISKUSŇ inhalation device 50/100 mcg bid with fluticasone propionate DISKUSŇ inhalation device 100 mcg bid as initial maintenance treatment in adult and adolescent subjects with symptomatic, persistent asthma not controlled on short-acting bronchodilators alone. (Program of ADVAIRŇ Control and Effectiveness - Initial Maintenance Treatment, PACE – IMT study).
SCO100250 IV A Randomized, Double-Blind, Parallel-Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS 250/50mcg BID with Salmeterol DISKUS 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
SCO104925 IV Evaluation of Novel Endpoints in Subjects with Chronic Obstructive Pulmonary Disease (COPD) in a Randomized, Double-Blind, Placebo-Controlled Study of Treatment with Fluticasone Propionate/Salmeterol 500/50mcg combination and its individual components, Fluticasone Propionate 500mcg and Salmeterol 50mcg
SCO104962 IV A randomized, double-blind, double dummy, 3 way cross-over study evaluating the effects of SERETIDE™ 50/500mcg twice daily plus tiotropium bromide 18mcg once daily compared with the individual treatments (tiotropium bromide 18mcg alone and SERETIDE™ 50/500mcg alone) in the treatment of subjects with COPD.
SCO30005 IV A 13-week, double-blind, parallel-group, multicentre study to compare the bronchial anti-inflammatory activity of the combination of salmeterol/ fluticasone propionate (SERETIDE™/ADVAIR™/VIANI™) 50/500 mcg twice daily compared with placebo twice daily in patients with Chronic Obstructive Pulmonary Disease SERETIDE, ADVAIR and VIANI are registered trademarks of the GlaxoSmithKline group of companies.
SCO30006 IV A randomised, double-blind, parallel-group study to investigate the protective effect of the combination of fluticasone and salmeterol (500/50µg bid via the DISKUS) compared with salmeterol (50µg bid via the DISKUS) on the incidence of moderate to severe exacerbations in patients with severe chronic obstructive pulmonary disease (COPD) (GOLD III/IV)
SCO30008 IV A single centre, randomised, double-blind, double dummy, parallel group 3-week study to compare the effect of the salmeterol/fluticasone propionate combination 50/500mcg bd via the DISKUS™/ACCUHALER™ inhaler with tiotropium bromide 18 mcg od via the Handihaler inhaler on mucociliary clearance rate in patients with Chronic Obstructive Pulmonary Disease (COPD).
SCO40002/SER9602/COSMIC IV SCO400002/SER9602/COSMIC: One year withdrawal of fluticasone propionate after three months treatment with combined salmeterol/fluticasone propionate in COPD: the COSMIC study.
SCO40011 IV A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparative Clinical Trial Evaluating Fluticasone Propionate/Salmeterol 250/50mcg BID via DISKUS) to Ipratropium Bromide/Albuterol Sulfate (36mcg/206mcg QID) Inhalation Aerosol in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
SCO40012 IV A Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparative Clinical Trial Evaluating Fluticasone Propionate/Salmeterol (250/50mcg BID via DISKUS) to Ipratropium Bromide/Albuterol Sulfate (36mcg/206mcg QID) Inhalation Aerosol in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
SCO40030 IV A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Clinical Trial Evaluating the Effect of the Fluticasone Propionate/Salmeterol Combination Product 250/50mcg BID via DISKUS and Salmeterol 50mcg BID via DISKUS on Lung Hyperinflation in Subjects with Chronic Obstructive Pulmonary Disease (COPD).
SCO40034 IV A multicentre, randomised, double-blind, double dummy, parallel group 12-week exploratory study to compare the effect of the salmeterol/fluticasone propionate combination product (SERETIDE™) 50/500mcg bd via the DISKUS™/ACCUHALER™ inhaler with tiotropium bromide 18 mcg od via the Handihaler inhalation device on efficacy and safety in patients with Chronic Obstructive Pulmonary Disease (COPD).
SCO40036 IV Multicentre, Randomised, Double-Blind, Double Dummy, Parallel Group, 104-week Study to Compare the Effect of the Salmeterol/Fluticasone Propionate Combination Product (SERETIDE*) 50/500mcg Delivered Twice Daily via the DISKUS*/ACCUHALER* Inhaler with Tiotropium Bromide 18 mcg Delivered Once Daily via the HandiHaler Inhalation Device on the Rate of Health Care Utilisation Exacerbations in Subjects with Severe Chronic Obstructive Pulmonary Disease (COPD)
SCO40041 IV 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)
SCO40043 IV A Randomized, Double-Blind, Parallel-Group, 52-Week Study to Compare the Effect of Fluticasone Propionate/Salmeterol DISKUS® 250/50mcg BID with Salmeterol DISKUS® 50mcg BID on the Annual Rate of Moderate/Severe Exacerbations in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
SFA100062 IV A Randomized, Parallel Group, Double-Blind, Comparative Trial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Asthma, Who Have Either a B16-Arg/Arg, a B16-Gly/Gly or a B16-Arg/Gly Genotype and are Treated With Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg or Salmeterol DISKUS 50mcg BID
SFA100314 IV 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 in Adolescent Subjects with Activity-Induced Bronchospasm
SFA100316 IV 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 in Adolescent Subjects with Activity-Induced Bronchospasm
SFA103081 IV An Open-Label, Multi-centre, Randomized, Parallel Group Clinical Effectiveness Study to Determine the Level of Asthma Control in Adolescent and Adult Patients Treated with ADVAIR versus Usual Care for 24 Weeks
SFA103153 IV 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.
SFCF 4002 IV Asthma controlled by SeretideŇ in adults with persistent moderate asthma : efficacy in preventing exacerbations and quality of life
SFCF 4026/SAM40088 IV Maintenance of asthma control in adults: comparison of three therapeutic strategies in patients whose asthma is controlled by a medium dose of inhaled corticosteroid and a long-acting inhaled beta2-agonist
SFCF4001 IV Uncontrolled asthma in adults: comparison of combination FP/salmeterol (administered via Diskus) with doubling the dosage of inhaled corticosteroid + long acting ß2-mimetic or adding long acting ß2-mimetic to corticosteroid previously inhaled.
SFCF4006 IV Study of control of moderate to severe asthma with Seretide in general practice.
SFCF4007 (SAM40051) IV Comparison of the efficacy and safety of Seretide and beclomethasone dipropionate plus montelukast in asthma.
SFCF4020 IV Asthma control: evaluation in adults during treatment with Seretide
SFCF4021 IV Research of predictive factors for the response to Seretide® in chronic obstructive pulmonary disease patients with FEV1<50%
SLGA5021 IV A randomized, double-blind clinical trial comparing the efficacy and safety of salmeterol xinafoate 42mcg b.i.d.* plus fluticasone propionate 88mcg b.i.d.* versus fluticasone propionate 220mcg b.i.d.* alone in subjects with asthma not well controlled on fluticasone propionate 88mcg b.i.d.* (*Doses quoted are ex-actuator: equivalent ex-valve doses are 50mcg, 100mcg and 250mcg, respectively)
SLGA5022 IV A randomised, double-blind clinical trial comparing the efficacy and safety of salmeterol xinafoate 42mcg b.i.d.* plus fluticasone propionate 88mcg b.i.d.* versus fluticasone propionate 220mcg b.i.d.* alone in subjects with asthma not well controlled on fluticasone propionate 88mcg b.i.d.*(*Doses quoted are ex-actuator: equivalent ex-valve doses are 50mcg, 100mcg and 250mcg, respectively)
VIA-001 IV Cost-effectiveness of a combination of Fluticasone Propionate and Salmeterol Xinafoate in comparison with conventional therapies of bronchial asthma (VIANI® Real life).
VIA-002 IV Viani® forte Discus® Post Marketing Surveillance Study.
VIAPAED 102318 IV Steroid-sparing with the salmeterol/fluticasone propionate 50/100µg b.i.d. combination compared to fluticasone propionate 200µg b.i.d. alone in the management of children and adolescents with moderate persistent asthma.
WEUKBRE1157 / EPI#40472 IV Assessment of the Risk of Pneumonia among COPD Patients on Seretide or Inhaled Corticosteroids in the UK primary care
WEUKSTV1076 IV Assessment of incidence of pneumonia among COPD patients with or without exposure to inhaled steroids in the General Practice Research Database (GPRD)
815DA-02 (SAS30035) III A 52-week multi-centre, open-labelled, non-comparative study assessing the safety of salmeterol xinafoate/fluticasone propionate bid in adult patients with bronchial asthma
RPS30001_SFCF3002 III A Multicentre, Randomised, Double-Blind, Double-Dummy, Parallel-Group Study to establish Equivalence of the Fluticasone propionate/Salmeterol Combination (FSC) Product (100/50µg) via either the Reservoir Powder Inhalation Device (RPID) or via the Diskus* Inhaler over 12 Weeks in Children with Asthma
RPS30002_SFCF3001 III A Multicentre, Randomised, Double-Blind, Double-Dummy, Parallel-Group Study to Establish Equivalence of the Salmeterol/Fluticasone propionate Combination Product (50/250µg) via either the Reservoir Powder Inhalation Device (RPID) or via the Diskus™ Inhaler over 12 Weeks in Adolescents and Adults with moderate Asthma
SAM30002 III A randomised, multi-centre, double blind, double-dummy, parallel-group comparison of Seretide RPID (50/100µg strength) bd with budesonide BADPI 400µg bd in steroid experienced adolescents and adults with reversible airways obstruction.
SAM30003 III A multicentre, randomised , open-label, parallel group comparison of Seretide Accuhaler TM (50/250 or 50/500mg strength salmeterol/fluticasone propionate) bd with salmeterol 50mg twice daily via one Accuhaler and either fluticasone propionate 250mg or 500mg twice daily via a separate Accuhaler in adults with reversible airways disease.
SAM30008 III A multi-centre, randomized, open-label, parallel-group, comparison study of the salmeterol/fluticasone propionate combination product via one Diskus/Accuhaler inhaler with salmeterol via one Diskus/Accuhaler inhaler and fluticasone propionate via another Diskus/Accuhaler inhaler in adults with asthma
SAM30013 III A 12 week, randomized, double-blind, parallel group study to compare the efficacy and safety of salmeterol/fluticasone propionate/GR106642X (25/50 µg x 2 inhalations) bid with fluticasone propionate (125 µg x 2 inhalations) bid in adolescent and adult patients with mild to moderate asthma.
SAM30021 III A multi-centre, randomised, open-label, parallel group clinical trial to assess the efficacy and safety of Salmeterol/Fluticasone Propionate combination product (2x 25/125mg/actuation, bd) via a hydrofluoroalkane metered-dose inhaler compared with Salmeterol/Fluticasone Propionate AccuhalerÔ (50/250mg bd) in adult Chinese patients with mild to moderate asthma.
SAM40116 / Dutch code SER0203 III A 12-week multi-centre, randomised, double blind, parallel group study to compare the efficacy of salmeterol/fluticasone propionate (Seretide TM) 50/100 mcg or 50/250 mcg twice daily and fluticasone propionate (Flixotide TM) 250 mcg or 500 mcg twice daily via the Diskus TM in subjects with asthma/COPD symptoms.
SAS110099 III Clinical Assessment of GW815SF (SLM/FP) HFA MDI in Paediatric Patients With Bronchial Asthma – A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate Dry Powder Inhaler (DPI) Plus Fluticasone Propionate DPI and to Assess Long-Term Safety of GW815SF HFA MDI
SAS110101 III Clinical Assessment of GW815SF (SLM/FP) HFA MDI in Paediatric Patients With Bronchial Asthma – A Long Term (24-Week) Study
SAS30001 III A Randomized, Double-Blind, Active-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol/Fluticasone Propionate Combination in HFA 134a MDI, 42/88mcg BID, and Salmeterol in Propellant 11/12 MDI, 42mcg BID, and Fluticasone Propionate in Propellant 11/12 MDI, 88mcg BID, in Adolescent and Adult Subjects with Asthma
SAS30003 III A Stratified, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol/Fluticasone Propionate Combination in HFA 134a MDI, 42/88mcg BID, and Salmeterol in Propellant 11/12 MDI, 42mcg BID, Fluticasone Propionate in Propellant 11/12 MDI, 88mcg BID, and Placebo Propellant HFA 134a MDI in Adult and Adolescent Subjects with Asthma
SAS30004 III A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol/Fluticasone Propionate Combination in GR106642X MDI, 50/250mcg BID, and Salmeterol in Propellant 11/12 MDI, 50mcg BID, Fluticasone Propionate in Propellant 11/12 MDI, 250mcg BID, and Placebo Propellant GR106642X MDI in Adult and Adolescent Subjects with Asthma
SAS30005 III A 12-Month, Open-Label, Stratified Study to Assess the Long-Term Safety of Salmeterol/Fluticasone Propionate/HFA134a Inhalation Aerosol at Doses of 50/100mcg, 50/250mcg, and 50/500mcg BID in Adolescent and Adult Subjects with Asthma
SAS30015 III A phase IIIB, multi-centre, double-blind, parallel group, randomised study to compare the efficacy of the salmeterol/fluticasone propionate combination (25/50 mcg strength), 2 inhalations bd via HFA-MDI with beclomethasone dipropionate (BDP) 200mcg bd via metered dose inhaler (MDI) in adolescents and adults with asthma
SAS30017 III A Randomized, Double-Blind, Active-Controlled, Parallel-Group, 12-Week Trial Evaluating the Safety and Efficacy of the Salmeterol 50mcg/Fluticasone Propionate 100mcg DISKUS Combination Product BID Compared with Salmeterol 50mcg via DISKUS BID and Fluticasone Propionate 100mcg via DISKUS BID in Symptomatic Adult and Adolescent Subjects with Asthma on Short-Acting Beta2-Agonist Therapy
SAS30018 III Comparison of stepwise treatment of asthmatic children with salmeterol/fluticasone propionate (FP) combination product (Seretide) and/or fluticasone propionate (Flixotide) based on PD20 methacholine plus symptoms or based on symptoms only (Children Asthma Therapy Optimal”)
SAS30019 III A multicentre, randomised, double-blind, double-dummy, parallel group study to compare the salmeterol/fluticasone propionate combination (SERETIDE/VIANI/ADVAIR) delivered via either a dry powder inhaler (DISKUS/ACCUHALER) or via a non-chlorofluorocarbon (CFC) metered-dose inhaler (MDI), both at a dose of 50/100µg twice daily for 12 weeks, in the treatment of children aged 4-11 years with asthma
SAS30021 III 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 Pediatric Subjects (4-11 Years) With Asthma
SAS30022 III A randomized, double-blind, placebo-controlled, parallel-group, 12-week trial evaluating the efficacy and safety of the fluticasone propionate/salmeterol DISKUS combination product 250/50mcg once daily versus fluticasone propionate/salmeterol DISKUS combination product 100/50mcg twice daily versus fluticasone propionate DISKUS 250mcg once daily versus placebo in symptomatic adolescent and adult subjects with asthma that is not controlled on short acting beta2-agonists alone
SAS30023 III A 12-week multicentre, randomised, double-blind, placebo-controlled parallel group study to compare the efficacy and tolerability of fluticasone propionate/salmeterol combination (SERETIDE/VIANI/ADVAIR) 88/42mcg once daily in the morning with fluticasone propionate 88mcg once daily in the morning and placebo (short-acting ß2-agonist as required only) once daily in the morning, all via the HFA MDI as initial maintenance therapy in mild asthmatic subjects
SAS30024 III A 52-week multicentre, randomised, double-blind, double dummy, placebo-controlled parallel group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination (SERETIDE/VIANI/ADVAIR) 50/100mcg once daily in the morning with fluticasone propionate (FLIXOTIDE/FLOVENT) 100mcg twice daily and placebo twice daily, all via the DISKUS/ACCUHALER as initial maintenance therapy in mild asthmatic subjects
SAS30031 III A Randomized, Double-Blind, 12-Week Trial Evaluating the Safety of the Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg BID Versus Fluticasone Propionate DISKUS 100mcg BID in Symptomatic Pediatric Subjects (4-11 Years) With Asthma
SAS30033 III An Open-Label, Multi-Center Study to Evaluate the Performance and Patient Satisfaction of Fluticasone Propionate/Salmeterol HFA with Counter in Asthma or COPD Subjects at Least 12 Years of Age
SAS30036 III A Double-Blind, Comparative Study to Compare Salmeterol/Fluticasone Propionate Combination Product (50/250mcg BID) with Concomitant Treatment with Fluticasone Propionate 250mcg BID Plus Sustained Release Theophylline 200mg bid in Patients with Bronchial Asthma
SAS30038 III Clinical assessment of GW815SF (SLM/FP) for bronchial asthma - An open-labelled study of GW815SF (SLM/FP) 50/100mcg in patients with bronchial asthma (uncontrolled trial).
SAS30039 III A 12-week, multi-centre, randomised, double-blind, parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination (SERETIDE™/VIANI™/ADVAIR™) 50/250µg twice-daily with fluticasone propionate 250µg twice-daily, all via the DISKUS®/ACCUHALER® as initial maintenance therapy in moderate persistent asthma.
SAS30040 III A 12-week, randomised, double-blind, parallel-group study to compare the efficacy and tolerability of salmeterol/fluticasone propionate combination 50/100mcg bd with fluticasone propionate 250mcg bd, all via the DISKUS™/ACCUHALER™ on maintaining asthma control in moderate persistent asthmatic subjects whose symptoms have been well-controlled following an initial maintenance therapy with salmeterol/fluticasone propionate 50/250mcg combination twice-daily for 12 weeks
SAS40002 (SERL05) III A Randomised, Double-Blind, Double-Dummy, Parallel-Group Comparison of Seretideä Diskus/Accuhalerä 250/50 mg bid with Budesonide 800 mg bid plus Formoterol 12.0 mg bid (both via Breath-Actuated Dry Powder Inhaler) in Adolescent and Adult Moderate-Severe Asthmatics
SB-207499/125 III A Randomized, 12-Week, Double-blind, Placebo-controlled, Parallel-group Pilot Study to Evaluate the Safety and Additional Efficacy of Adding a New Chemical Entity (NCE) to Treatment with ADVAIR 250/50 Twice Daily in Patients with Chronic Obstructive Pulmonary Disease (COPD).
SCO100470 III A multicentre, randomised, double-blind, parallel group, 24-week study to compare the effect of the salmeterol/fluticasone propionate combination product 50/250mcg, with salmeterol 50mcg both delivered twice daily via the DISKUS/ACCUHALER inhaler on lung function and dyspnoea in subjects with Chronic Obstructive Pulmonary Disease (COPD).
SCO100540 III A multi-centre, randomised, double-blind, parallel group study to investigate the efficacy and safety of the Salmeterol/fluticasone propionate combination at a strength of 50/500µg BD, compared with placebo via Accuhaler™, added to usual chronic obstructive pulmonary disease (COPD) therapy, in subjects with COPD for 24 weeks
SCO100646 III Clinical Evaluation of SFC for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) – Assessment of the Effect of Addition of Fluticasone Propionate to Salmeterol Xinafoate 50µg after Switching under Double-blinded Conditions to SFC 50/250µg in Chronic Obstructive Pulmonary Disease
SCO100648 III Clinical Evaluation of salmeterol xinafoate/fluticasone propionate combination (SFC) for Chronic Obstructive Pulmonary Disease (Chronic Bronchitis, Emphysema) - A Long-term Treatment Study of SFC 50/500µg in Chronic Obstructive Pulmonary Disease (COPD)
SCO30003 III A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (SERETIDE®/VIANI®/ADVAIR®) 50/500mcg bd, salmeterol 50mcg bd and fluticasone propionate 500mcg bd, all delivered via the DISKUS®/ACCUHALER® inhaler, on the survival of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment.
SFA106484 III A randomized, double-blind, double-dummy, 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.
SFCA3002 III A Randomized, Double-Blind, Parallel-Group Trial Evaluating Safety and Efficacy of Salmeterol 50mcg BID and Fluticasone Propionate 100mcg BID Individually and in Combination and Placebo in Subjects with Asthma
SFCA3003 III A Randomized, Double-Blind, Parallel-Group Trial Evaluating Safety and Efficacy of Salmeterol 50mcg BID and Fluticasone Propionate 250mcg BID Individually and in Combination and Placebo in Subjects with Asthma
SFCA3006 III A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Evaluating the Safety and Efficacy of the DISKUS Formulations of Salmeterol (SAL) 50mcg BID and Fluticasone Propionate (FP) 500mcg BID Individually and in Combination as Salmeterol 50mcg/Fluticasone Propionate 500mcg BID (SFC 50/500) Compared to Placebo in COPD Subjects
SFCA3007 III A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial Evaluating the Safety and Efficacy of the DISKUS Formulations of Salmeterol (SAL) 50mcg BID and Fluticasone Propionate (FP) 250mcg BID Individually and in Combination as Salmeterol 50mcg/Fluticasone Propionate 250mcg BID (SFC 50/250) Compared to Placebo in COPD Subjects
SFCB3017 III A multicentre randomised, double-blind, double-dummy, parallel group comparison of the salmeterol/fluticasone propionate combination product (50/100mcg strength) BID via one DISKUS/ACCUHALER inhaler with salmeterol 50mcg BID via one DISKUS/ACCUHALER inhaler and fluticasone propionate 100mcg BID via a second DISKUS/ACUHALER inhaler in adolescents and adults with reversible airways obstruction
SFCB3018 III A multicentre randomised, double-blind, double-dummy, parallel group six-month comparison of the salmeterol/fluticasone propionate combination product (50/250mcg strength) BID via one DISKUS/ACCUHALER inhaler with salmeterol 50mcg BID via one DISKUS/ACCUHALER inhaler and fluticasone propionate 250mcg BID via a second DISKUS/ACUHALER inhaler in adolescents and adults with reversible airways obstruction
SFCB3019 III A multicentre randomized, double-blind, double-dummy, parallel-group comparison of the salmeterol/fluticasone propionate combination product (50/500mcg strength) BD via one DISKUS/Accuhaler inhaler with salmeterol 50mcg BD via one DISKUS/Accuhaler and fluticasone propionate 500mcg BD via another DISKUS/Accuhaler and with fluticasone propionate 500mcg BD via one DISKUS/Accuhaler in adolescents and adults with reversible airways obstruction
SFCB3020 III A Multicentre, Randomized, Double-Blind, Double-Dummy, Parallel-Group, Comparison of the Salmeterol/Fluticasone Propionate Combination Product (50/100mcg strength)BD Via One DISKUS/ACCUHALER Inhaler with Salmeterol 50mcg BD Via One DISKUS/ACCUHALER and Fluticasone Propionate 100mcg BD Via a Second DISKUS/ACCUHALER Inhaler in Children Aged 4-11 Years with Reversible Airways Obstruction
SFCB3022 III A multicentre, randomised, double-blind, double-dummy, parallel-group, three-month comparison of the salmeterol/fluticasone propionate combination product (2x25/50mcg strength) bd via the pressurised metered dose inhaler with salmeterol/fluticasone propionate combination product (1x50/100mcg strength) bd via the Diskus/Accuhaler™ inhaler and with fluticasone propionate (2x 50mcg strength) alone bd via the pressurised metered dose inhaler in adolescents and adults with reversible airways obstruction
SFCB3023 III A multicentre, randomised, double-blind, double-dummy, parallel-group, three-month comparison of the salmeterol/fluticasone propionate combination product (2x25/250mcg strength) bd via the pressurised metered dose inhaler with salmeterol/fluticasone propionate combination product (1x50/500mcg strength) bd via the Diskus/Accuhaler™ inhaler and with fluticasone propionate (2x 250mcg strength) alone bd via the pressurised metered dose inhaler in adolescents and adults with reversible airways obstruction
SFCB3024 III A multicentre, randomised, double-blind, parallel group, placebo-controlled study to compare the efficacy and safety of the salmeterol/FP combination product at a strength of 50/500mcg bd with salmeterol 50mcg bd alone and FP 500mcg bd alone, delivered via the DISKUS™/ACCUHALER™, in the treatment of subjects with chronic obstructive pulmonary disease (COPD) for 12 months
SFCT01 (SCO30002) III A Multicentre, Randomised, Double-Blind, Parallel Group, Placebo-Controlled Study to Compare the Efficacy and Safety of Inhaled Salmeterol/Fluticasone Propionate Combination Product 25/250 µg Two Puffs Bd and Fluticasone Propionate 250µg Two Puffs Bd Alone, All Administered Via Metered Dose Inhalers (MDI), in the Treatment of Subjects with Chronic Obstructive Pulmonary Disease (COPD) for 52 Weeks
C92_029 I A study to evaluate the safety, tolerability and systemic pharmacodynamics effects of salmeterol in the salmeterol/fluticasone propionate (FP)/HFA134a inhaler
RPS10001/SFCF1001 I A phase I, monocentric, randomised, double-blind, double-dummy, cross-over study to compare the pharmacokinetics and the pharmacodynamic effects of Seretide 50 mg/250 mg bid after repeat dosing, delivered by Diskus™ versus RPID in patients with moderate asthma.
SAS10001 I Systemic pharmacodynamic effects of salmeterol, delivered over 3 hours in a cumulative dosing series, from salmeterol/fluticasone propionate/HFA134A metered-dose inhaler (MDI) to total dose 400/2000mcg, in comparison with salmeterol/P 11/12 MDI to total dose 400mcg, and placebo, in a randomised, double-blind, placebo-controlled, three-way cross-over study in healthy subjects
SAS10002 I A Four-Period Crossover, Placebo Controlled Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects of Salmeterol/Fluticasone Propionate/HFA134A via MDI in Combination Compared With Salmeterol/P11/12 and Fluticasone Propionate/P11/12 via MDI Administered Individually
SAS10003 I A Double-Blind, Placebo-Controlled Four Way Crossover Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Fluticasone Propionate and Salmeterol With Increasing Dose Strengths of the Fluticasone Propionate/Salmeterol/HFA134A MDI Combination Product
SAS10005 I A part-randomized, single-blind, placebo-controlled, five-way crossover study to assess the absolute bioavailability, relative bioavailability and comparative pharmacodynamics of fluticasone propionate from ADVAIR HFA MDI, ADVAIR DISKUS, FP CFC MDI and intravenous FP and to assess the relative bioavailability and comparative pharmacodynamics of salmeterol from ADVAIR HFA MDI to ADVAIR DISKUS
SAS10006 I A 12-week, randomized, double-blind, placebo-controlled, 3-way crossover study in adult subjects with asthma aged 18-55 years to examine the pharmacodynamics and pharmacokinetics of fluticasone propionate (FP) administered twice daily via the DISKUS™ (FP 100mcg) and the FP/Salmeterol (SALM) combination product (FP 100mcg/SALM 50mcg) administered twice daily via the DISKUS
SAS10007 I A 16-week, randomized, double-blind, double-dummy, placebo-controlled, 4 way crossover study in adult subjects with asthma aged 18-55 years to examine the pharmacodynamics and pharmacokinetics of fluticasone propionate and salmeterol administered via FP/Salmeterol (SALM) combination product DISKUS (FP 250mcg/SALM 50mcg), FP/Salmeterol combination metered dose inhaler (MDI) (FP 110mcg/SALM 21mcg) containing the hydrofluoroalkane (HFA) propellant, GR106642X, and FP MDI (FP 110mcg) containing HFA propellant.
SAS10013 I An open, parallel group, repeat dose study to determine the pharmacokinetics (PK) and pharmacodynamics (PD) of salmeterol and fluticasone propionate delivered as SERETIDE DISKUS (50/250mcg twice daily [b.i.d.]) in Japanese and Caucasian asthmatic subjects. Seretide and Diskus are registered trademarks of the GlaxoSmithKline group of companies.
SAS10014 I A study to compare the systemic pharmacodynamic effects and pharmacokinetics of SERETIDE DISKUS/ACCUHALER Inhaler (200/1000mcg) with salmeterol alone (200mcg) and fluticasone propionate alone (1000mcg) in healthy Japanese subjects
SAS10015 I A randomised, double-blind, double-dummy, cross-over, repeat dose study to compare the effects of SERETIDE DISKUS (salmeterol/fluticasone propionate combination; 50/250mcg) with co-administered salmeterol (50mcg) and fluticasone propionate (250mcg) DISKUS on lung function in Japanese and Caucasian asthmatic subjects
SAS10016 I A 2-week, randomized, double-blind, parallel-group study in pediatric subjects with asthma aged 4 to11 years to examine the pharmacokinetics (PK) of fluticasone propionate (FP) and salmeterol (SALM) from the FP/SALM combination product administered twice daily via the DISKUS (FP 100mcg/SALM 50mcg) and the FP DISKUS (FP 100mcg) – Incorporating a population pharmacokinetic analysis with additional data provided from study SAS30031
SAS10017 I A randomised, double-blind, single-dose, replicated 4-way crossover study to compare systemic exposure and pharmacodynamics of fluticasone propionate (FP) and salmeterol (SALM) from two batches of SALM/FP MDI with different in vitro characteristics.
SAS10019 I A repeat dose, randomised, double blind, two-way crossover study to assess the safety and systemic exposure of an investigational formulation compared to concurrent administration of individual fluticasone propionate 50 and salmeterol 50 DISKUS™ inhalers in subjects aged 18– 55 years with mild asthma.
SAS10020 I A single dose, randomised, double-blind, 2-way crossover study to assess the safety, tolerability, pharmacodynamics and pharmacokinetic profile of SERETIDE™ 50/50 compared to concurrent administration of individual FP 50 and SALM 50 inhalers in healthy subjects aged 18 – 55 years.
SAS101877 I A randomised, open label, five-.way crossover study to assess the systemic exposure of fluticasone propionate (FP) and salmeterol (SALM) from SERETIDE™/ADVAIR™ 250 HFA MDI without spacer, with AeroChamber-Plus spacer, with AeroChamber-Max spacer, with VOLUMATIC™ spacer and SERETIDE™/ADVAIR™ 500 DISKUS™/ACCUHALER™ in adult subjects with mild or intermittent asthma
SAS104449 I A randomised, open label, five-way crossover study to assess the systemic exposure of fluticasone propionate and salmeterol from salmeterol/fluticasone propionate (SALM/FP) 25/250 MDI without spacer and with AeroChamber-Max spacer and VOLUMATIC both in their washed and unwashed states in adult asthmatics with mild or intermittent asthma.
SCO100807 I Randomised, open label, two period, crossover study to compare the steroid systemic exposure of Fluticasone Propionate (FP) from FP/Salmeterol (SALM) (500/50) DISKUS and Budesonide (BUD) from BUD/formoterol (FOR). (200/6) Turbuhaler in patients with severe Chronic Obstructive Pulmonary Disease.
SFCB1001 I A study to evaluate the safety, tolerability and systemic pharmacodynamic effects of salmeterol in the salmeterol/FP DISKUS™ inhaler
SFCB1002 I A study to evaluate the safety, tolerability, pharmacokinetics and systemic pharmacodynamic effects of fluticasone propionate in the salmeterol/fluticasone propionate DISKUS™ inhaler
SFCB1004 I The systemic pharmacodynamic effects and pharmacokinetics of salmeterol and fluticasone propionate when given alone and in combination, after repeat dosing from DISKUS™ inhalers in healthy volunteers
SFCB1005 I The systemic pharmacodynamic effects and pharmacokinetics of salmeterol and fluticasone propionate when given together, from either a single or two separate DISKUS™ inhalers, in single doses