Salmeterol Xinafoate

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G Steinkamp - One of the best experts on this subject based on the ideXlab platform.

  • Salmeterol fluticasone propionate 50 250 microg combination is superior to double dose fluticasone 500 microg for the treatment of symptomatic moderate asthma
    Swiss Medical Weekly, 2004
    Co-Authors: Karlchristian Bergmann, L Lindemann, R Braun, G Steinkamp
    Abstract:

    QUESTIONS UNDER STUDY if patients with asthma remain symptomatic in spite of chronic treatment with inhaled corticosteroids (ICS), increasing the ICS dosage or adding another drug to the treatment regimen are possible therapeutic alternatives. We compared the efficacy and safety of combined Salmeterol fluticasone therapy (SFC, 50/250 microg twice daily) with twice the dose of fluticasone propionate (FP, 500 microg b.i.d.) in symptomatic asthmatics. METHODS this prospective, double-blind study was conducted in 76 study centres. 365 symptomatic patients with moderate asthma aged >18 years and receiving ICS in a dose equivalent to 1000 microg beclomethasone propionate per day were randomly assigned to receive either Salmeterol Xinafoate (50 microg) and fluticasone propionate (250 microg) in a single dry powder inhaler (Diskus) or 500 microg FP twice daily. The primary efficacy endpoint was morning peak expiratory flow rate (PEFR). Secondary measurements included forced expiratory volume in 1 second (FEV1), asthma symptom scores, and use of rescue medication. RESULTS combined Salmeterol fluticasone therapy resulted in significantly greater improvements in PEFR and symptom control than doubling the dose of FP. At week 12, morning PEFR had increased by 52 L/min from baseline in patients on SFC and by 36 L/min in subjects receiving FP. The adjusted difference between groups was 16.6 L/min (95% confidence interval, 1.1 to 32.0 L/min). In the SFC group, the percentage of symptom-free days increased from baseline by 49% of days as compared with 38% of days after FP (adjusted difference: 12.6% of days, 95% CI 4.0 to 20.7). Quality of life improved to a greater degree after SFC therapy, and patients regarded study drugs as superior to their previous asthma medication. Adverse event profiles were similar between groups. CONCLUSIONS the combination of Salmeterol 50 microg and fluticasone 250 microg in a single dry powder inhaler was superior to twice the dose of FP (500 microg). It seems justified to add Salmeterol rather than increasing the ICS dose if symptomatic asthmatics require supplementary therapy.

Nicolas Roche - One of the best experts on this subject based on the ideXlab platform.

  • an innovative corticosteroid long acting β2 agonist breath triggered inhaler facilitating lung delivery of fluticasone propionate formoterol fumarate for the treatment of asthma
    Expert Opinion on Drug Delivery, 2019
    Co-Authors: Omar S. Usmani, Nicolas Roche, Jonathan Marshall, Helen Danagher, David Price
    Abstract:

    Introduction: Incorrect inhaler technique is one reason why the efficacies of inhaled asthma treatments in clinical trials and effectiveness in the real world differ. Inhaler technique is critical for drug delivery to the lungs; incorrect technique negatively impacts asthma control and long-term outcomes. Breath-triggered inhalers (BTIs) can simplify drug administration and are suitable for most patients, including those with reduced inspiratory flow. Until recently, no inhaled corticosteroid/long-acting β2-agonist combination BTI was available in Europe. The flutiform® (fluticasone propionate/formoterol fumarate [FP/FORM]) k-haler® is the first combination BTI now approved in Europe for asthma maintenance treatment.Areas covered: We review studies examining the challenges posed to patients by different inhaler types and explore evidence demonstrating the clinical efficacy of FP/FORM administered via a pressurized metered-dose inhaler. We also review the pharmacokinetic/pharmacodynamic studies supporting FP/FORM k-haler use, and consider data showing high lung deposition with the device. Finally, we review patient experiences using the BTI, device characteristics, and health economic aspects.Expert opinion: Despite the availability of therapies, asthma control levels remain low, and there is a clear need for easy-to-use inhalers. Research to increase our understanding of critical errors with each inhaler and how to overcome them is important for improving care.Abbreviations: AUCt: area under the plasma concentration-time curve from the time of dosing to the last measurable concentration; BDP: beclometasone dipropionate; BTI: breath-triggered inhaler; BUD: budesonide; CI: confidence interval; Cmax: maximum observed plasma concentration; DPI: dry powder inhaler; FDC: fixed-dose combination; FEV1: forced expiratory volume in 1 s; FORM: formoterol fumarate; FP: fluticasone propionate; HCP: health-care professional; ICS: inhaled corticosteroid; LABA: long-acting β2-agonist; OR: odds ratio; PIL: patient information leaflet; pMDI: pressurized metered-dose inhaler; SAL: Salmeterol Xinafoate.

  • real life use of fluticasone propionate Salmeterol in patients with chronic obstructive pulmonary disease a french observational study
    BMC Pulmonary Medicine, 2014
    Co-Authors: Nicolas Roche, C Pribil, Eric Van Ganse, Philippe Serrier, B Housset, Deborah Poirier, Nathalie Texier, S Schuck, I Boucot
    Abstract:

    Background In Europe, administration of an inhaled corticosteroid (ICS) combined with a long-acting β2 agonist is approved in chronic obstructive pulmonary disease (COPD) patients with a pre-bronchodilator FEV1 < 60% predicted normal, a history of repeated exacerbations, and who have significant symptoms despite regular bronchodilator therapy. Minimal data are available on the use of the fluticasone propionate/Salmeterol Xinafoate combination (FSC) in the real-life COPD setting and prescription compliance with the licensed specifications.

Kathleen Rickard - One of the best experts on this subject based on the ideXlab platform.

  • Salmeterol powder provides significantly better benefit than montelukast in asthmatic patients receiving concomitant inhaled corticosteroid therapy
    Chest, 2001
    Co-Authors: James E Fish, Amanda Emmett, Elliot Israel, John J Murray, Rebecca Boone, Steven W Yancey, Kathleen Rickard
    Abstract:

    Study objectives: Comparison of inhaled Salmeterol powder vs oral montelukast treatment in patients with persistent asthma who remained symptomatic while receiving inhaled corticosteroids. Design: Randomized, double-blind, double-dummy, parallel-group, multicenter trials of 12-week duration. Setting: Outpatients in private and university-affiliated clinics. Patients: Male and female patients > 15 years of age with a diagnosis of asthma (baseline FEV1 of 50 to 80% of predicted) and symptomatic despite receiving inhaled corticosteroids. Interventions: Inhaled Salmeterol Xinafoate powder, 50 mg bid, or oral montelukast, 10 mg qd. Measurements and results: Treatment with Salmeterol powder resulted in significantly greater improvements from baseline compared with montelukast for most efficacy measurements, including morning peak expiratory flow (35.0 L/min vs 21.7 L/min; p < 0.001), percentage of symptom-free days (24% vs 16%; p < 0.001), and the percentage of rescue-free days (27% vs 20%; p 5 0.002). Total supplemental albuterol use was decreased significantly more in the Salmeterol group compared with the montelukast group (2 1.90 puffs per day vs 2 1.66 puffs per day; p 5 0.004) and nighttime awakenings per week decreased significantly more with Salmeterol than with montelukast (2 1.42 vs 2 1.32; p 5 0.015). Patients treated with inhaled Salmeterol were significantly more satisfied with their treatment regimen and how well, how fast, and how long it worked than were patients who were treated with oral montelukast. The safety profiles for the two treatments were similar. Conclusion: In patients with persistent asthma who remain symptomatic while receiving inhaled corticosteroids, adding inhaled Salmeterol powder provided significantly greater improvement in lung function and asthma symptoms and was preferred by patients over oral montelukast. (CHEST 2001; 120:423‐430)

  • efficacy safety and effects on quality of life of Salmeterol versus albuterol in patients with mild to moderate persistent asthma
    Annals of Allergy Asthma & Immunology, 1998
    Co-Authors: Sally E Wenzel, William R Lumry, Michael E Manning, Chris Kalberg, Fred M Cox, Amanda Emmett, Kathleen Rickard
    Abstract:

    Background Salmeterol Xinafoate is a long-acting, highly selective, beta 2 -adrenergic agonist that produces bronchodilation and clinically significant improvement in pulmonary function for up to 12 hours in patients with asthma. Objectives To evaluate the impact on asthma-specific quality of life, efficacy, and safety of Salmeterol versus albuterol in adult patients with mild-to-moderate persistent asthma. Methods A randomized, double-blind, double-dummy, parallel-group, multi-center study was conducted in 539 adult asthma patients over 12 weeks. Patients were randomized to receive either Salmeterol 42 micrograms via metered-dose inhaler twice daily or albuterol 180 micrograms four times daily. Upon entry into the study, 46% of patients were being treated with an inhaled corticosteroid and were allowed to continue treatment throughout the study. Pulmonary function and asthma symptoms were monitored daily, and patients completed the Asthma Quality of Life Questionnaire (AQLQ) at baseline and after 4, 8, and 12 weeks of treatment. Results Treatment with Salmeterol twice daily produced significantly greater improvements from baseline in all quality of life domains ("Activity Limitation," "Asthma Symptoms," "Emotional Function," "Environmental Function," "Environmental Exposure") scores and in the global AQLQ score at 12 weeks P Conclusions Salmeterol 42 micrograms administered twice daily is significantly more effective than albuterol 180 micrograms four times daily for improving asthma-specific quality of life, controlling asthma symptoms, and improving pulmonary function in patients with mild-to-moderate persistent asthma. Furthermore, those improvements were maintained over a 12-week period.

Christopher Marriott - One of the best experts on this subject based on the ideXlab platform.

  • aerodynamic deposition of combination dry powder inhaler formulations in vitro a comparison of three impactors
    International Journal of Pharmaceutics, 2010
    Co-Authors: Mohammed Taki, Christopher Marriott, Xian Ming Zeng, Gary P Martin
    Abstract:

    Abstract Inertial impaction is generally regarded as the ‘gold standard’ for the in vitro assessment of aerodynamic deposition of inhaled formulations. Despite the availability of several impactors, few studies have compared measurements of aerodynamic deposition using multiple impactors and none employed a combination formulation. The aerodynamic deposition of the combination dry powder inhaler (DPI) Seretide ® Accuhaler ® , which contains Salmeterol Xinafoate (SX) and fluticasone propionate (FP), was assessed using the Andersen cascade impactor (ACI), multi-stage liquid impinger (MSLI) and next generation impactor (NGI) and the results were compared. Two Seretide products were tested at flow rates of 30 and Q  L min −1 , the latter corresponding to a pressure drop of 4 kPa across the device. Significant differences in the particle size distributions were observed when the same formulation was tested using various impactors. The ACI was found to be less suitable for DPI testing at flow rates considerably higher than 28.3 L min −1 due to the significant overlap in the cut-off curves of the pre-separator and stage 0. This was not the case with the MSLI but the data derived were limited by the relatively small number of stages. Deposition data determined by the three impactors were significantly different. The NGI produced good resolution and minimal inter-stage overlap and was regarded as the impactor of choice for DPI testing.

  • investigations into the formulation of metered dose inhalers of Salmeterol Xinafoate and fluticasone propionate microcrystals
    Pharmaceutical Research, 2008
    Co-Authors: Darragh Murnane, Gary P Martin, Christopher Marriott
    Abstract:

    Purpose To investigate the aerosolization and behaviour of microparticles of Salmeterol Xinafoate (SX) and fluticasone propionate (FP) suspended in hydrofluoroalkane (HFA) propellant.

Daniela Traini - One of the best experts on this subject based on the ideXlab platform.

  • particle synergy and aerosol performance in non aqueous liquid of two combinations metered dose inhalation formulations an afm and raman investigation
    Journal of Colloid and Interface Science, 2011
    Co-Authors: Philippe Rogueda, Paul M Young, Robert Price, Timothy J Smith, Daniela Traini
    Abstract:

    Abstract The drug–drug interaction of two pMDI (pressure metered dose inhaler) combination products budesonide–formoterol fumarate dihydrate and Salmeterol Xinafoate–fluticasone propionate were investigated using in situ atomic force microscopy (AFM), equipped with a liquid cell filled with model a propellant, and Raman spectroscopy. Electron microscopy images of the budesonide–formoterol formulation suggested discrete particulates while the Salmeterol–fluticasone formulation appeared agglomerated. Based on the analysis of the AFM curves, it is proposed that interactions in the budesonide–formoterol system (cohesion and adhesion) are dominated by van der Waals forces while interactions between Salmeterol and fluticasone are of a chemical nature. Such observations are further substantiated by analysis of the Raman maps produced from pMDI actuations deposited on Andersen cascade impactor plates. The relevance of such synergy between particulates of different chemical nature is discussed. In particular, it is anticipated that strong interactions between particles could lead to heteroflocculation, increase aerosol particle size and consequently reduction of the respirable fine particle fraction.

  • the influence of flow rate on the aerosol deposition profile and electrostatic charge of single and combination metered dose inhalers
    Pharmaceutical Research, 2009
    Co-Authors: Susan Hoe, Daniela Traini, Hakkim Chan, Paul M Young
    Abstract:

    Purpose The capability of the electrostatic next generation impactor (eNGI) has been investigated as a tool capable of measuring the electrostatic charge of single (Flixotide™; containing fluticasone propionate (FP)) and combination (Seretide™; FP and Salmeterol Xinafoate (SX)) pressurised metered dose inhalers (pMDIs) at different flow rates.