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Chronic-obstructive pulmonary disease (COPD) is a global public health problem and its impact is increasing. Although only smoking cessation has been shown to alter the natural history of the disease, current treatment guidelines recommend the use of inhaled bronchodilators to decrease symptoms, improve lung function and quality of life and to prevent exacerbations. For a subset of patients with more severe disease, inhaled corticosteroids may also have a role in achieving these goals. Fluticasone propionate/salmeterol (Advair) or Seretide), GlaxoSmithKline) is a combination inhaled steroid and long-acting bronchodilator that is delivered by a dry-powder inhaler and was recently approved for use in COPD in the US. Fluticasone propionate/salmeterol is a potent bronchodilator and also appears to have important effects on the frequency of exacerbations and overall quality of life for some patients with COPD. Issues of patient selection as well as the pharmacology, efficacy and safety of the drug ...
Long-term use of fluticasone propionate/salmeterol fixed-dose combination and incidence of cataracts and glaucoma among chronic obstructive pulmonary disease patients in the UK General Practice Research Database David P Miller, Stephanie E Watkins, Tim Sampson, Kourtney J Davis WorldWide Epidemiology, GlaxoSmithKline, Durham, NC, USA Objectives: Some large population-based studies have reported a dose-related increased risk of cataracts and glaucoma associated with use of inhaled corticosteroids (ICS) in patients with asthma or chronic obstructive pulmonary disease (COPD). We evaluated the association between use of ICS-containing products, specifically fluticasone propionate/salmeterol fixed-dose combination (FSC), and incidence of cataracts and glaucoma among patients with COPD in a large electronic medical record database in the United Kingdom. Methods: We identified a cohort of patients aged 45 years and over with COPD in the General Practice Research Database (GPRD) between 2003 and 2006. Cases of
Evaluation of Fluticasone Propionate and Fluticasone Propionate/Salmeterol Combination on Exercise in Pediatric and Adolescent Patients with Asthma
A prescription event monitoring study to assess safety and health outcomes of Airtec SF® (salmeterol fluticasone propionate combination) in Indian population
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Absorption Fluticasone Propionate: Healthy Subjects: Fluticasone propionate acts locally in the lung; therefore, plasma levels do not predict therapeutic effect. Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of fluticasone propionate is negligible (,1%), primarily due to incomplete absorption and presystemic metabolism in the gut and liver. In contrast, the majority of the fluticasone propionate delivered to the lung is systemically absorbed.. Three (3) single-dose, placebo-controlled, crossover trials were conducted in healthy subjects: (1) a trial using 4 inhalations of ADVAIR HFA 230/21, salmeterol CFC inhalation aerosol 21 mcg, or fluticasone propionate CFC inhalation aerosol 220 mcg, (2) a trial using 8 inhalations of ADVAIR HFA 45/21, ADVAIR HFA 115/21, or ADVAIR HFA 230/21, and (3) a trial using 4 inhalations of ADVAIR HFA 230/21; 2 inhalations of ADVAIR DISKUS 500/50; 4 inhalations of fluticasone propionate CFC inhalation ...
Key clinical point: Patients with chronic obstructive pulmonary disease (COPD) fared better on an inhaled fixed-dose long-acting muscarinic antagonist/long-acting β2-agonist vs. an inhaled corticosteroid.Major finding: Patients who began umeclidinium/vilanterol (62.5/25 msg) therapy were less likely to progress to multiple-inhaler triple therapy (hazard ratio = 0.65; 95% CI, 0.47-0.89; P = .008) vs. fluticasone propionate/salmeterol (250/50 msg).
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Anti-inflammatory effects of salmeterol/fluticasone propionate 50/250 mcg combination therapy in Japanese patients with chronic obstructive pulmonary disease Kazuhisa Asai,1 Akihiro Kobayashi,2 Yukio Makihara,3 Malcolm Johnson4 1Department of Respiratory Medicine, Graduate School of Medicine, Osaka City University, Osaka, Japan; 2Biomedical Data Sciences, 3Medical Affairs Respiratory Department, GlaxoSmithKline, Tokyo, Japan; 4Respiratory Global Franchise, GlaxoSmithKline, Uxbridge, UK Purpose: Using sputum neutrophils as the primary measure, and other inflammation biomarkers, this study evaluated the anti-inflammatory effects of the combination salmeterol 50 mcg and fluticasone propionate 250 mcg (SFC 250) in Japanese patients with chronic obstructive pulmonary disease (COPD). Patients and methods: Patients were treated in a randomized, double-blind, parallel group, placebo-controlled trial with SFC 250 twice daily (n=26) or placebo (n=26) for 12 weeks. At the start and end of treatment, inflammation
OBJECTIVE: To compare risk of hospitalization or emergency department (ED) visit and healthcare costs in patients with chronic bronchitis initiating inhaled maintenance therapy with fluticasone propionate/salmeterol 250/50 mcg combination (FSC) versus other inhaled maintenance therapies.. DESIGN AND METHODS: This retrospective cohort study assessed 9,217 patients from the PharMetrics administrative claims database enrolled from July 1997 to January 2005. Study subjects were persons with medical claims with diagnoses of chronic bronchitis (ICD-9-CM 491.xx) who also had pharmacy claims for FSC, salmeterol (SAL), inhaled corticosteroid (ICS), ipratropium (IPR), or ipratropium/albuterol combination (IAC). Persons with ,12 months of continuous eligibility after the first prescription for initial maintenance therapy (index date) were excluded as were those receiving fluticasone propionate/salmeterol 100/50 mcg or 500/50 mcg (not indicated for patients with chronic bronchitis). For remaining persons, ...
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Local Lung Function And Airway Size Response During Methacholine Challenge And Salbutamol Treatment Measured Using High-Resolution Dynamic CT And Functional Lung Imaging
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In a double-blind randomised placebo-controlled trial, we showed that sustained treatment with intravenous salbutamol considerably reduced extravascular lung water in humans with ALI/ARDS.19 In contrast with our initial hypothesis and supporting data from animal studies,27 the response was not evident until 48 h after the initiation of treatment. Our study sought to identify whether salbutamol was having an effect on pulmonary neutrophil accumulation and alveolar inflammation. Our study confirms previous observations that there is increased neutrophil accumulation and inflammation in the alveolar space in people with ALI/ARDS. The novel finding of a positive association between the intensity of neutrophilic infiltration and an in vivo measurement of alveolar-capillary permeability adds additional support to the hypothesis that the neutrophil is a key inflammatory mediator in ARDS. Contrary to in vitro, animal and healthy volunteer studies, we found no evidence that intravenous salbutamol ...
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1. Airway responses to inhaled salbutamol were measured in two groups of six normal non-atopic subjects. In each group there was a dose-dependent increase in specific airways conductance after salbutamol inhaled in cumulative doses from 25 to 600 μg.. 2. In the first group these studies were repeated weekly during and after the subjects had taken regular inhaled salbutamol for 4 weeks, in doses increasing to 500 μg four times daily by week 4. Then, while subjects were continuing to receive regular salbutamol, the studies were repeated after 48 h of inhaled sodium cromoglycate (20 mg four times daily) and again after 48 h of beclomethasone dipropionate (200 μg four times daily).. 3. In the second group the studies were repeated after 10 days of regular inhaled salbutamol (500 μg four times daily).. 4. There was no change in airway response to inhaled salbutamol after 4 weeks or 10 days regular salbutamol therapy, or after 48 h of sodium cromoglycate or beclomethasone dipropionate ...
Aims: To investigate whether aerosol-type fluticasone propionate/formoterol combination (FFC) controls residual eosinophilic inflammation in the distal airways of well-controlled asthmatic patients more effectively than salmeterol/fluticasone propionate combination (SFC).. Methods: Subjects comprised 32 outpatients (61.9±17.0 years) with well-controlled moderate asthma who had used SFC for more than 4 weeks. Evidence of eosinophilic cationic protein (ECP) in 10% hypertonic saline-induced sputum was assessed, together with pulmonary function tests, respiratory resistance, exhaled nitric oxide (FeNO) and an Asthma Control Questionnaire (ACQ-5).. Results: ECP levels in late-phase sputum (117.6±144.7 mg/L at study entry) were significantly decreased 65.7±89.5 (p=0.019) at 4 weeks in the FFC group, but not in the SFC group. FeNo levels (44.8±23.5 ppb at study entry) were also significantly decreased to 37.8±23.5 (p=0.025) at 4 weeks in the FFC group. None of the indexes of pulmonary function ...
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The combination of salmeterol and fluticasone propionate has a broad spectrum of antiinflammatory effects in both current and former smokers with chronic obstructive pulmonary disease, which may contribute to clinical efficacy.
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TY - JOUR. T1 - Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. AU - Bailey, William. AU - Castro, Mario. AU - Matz, Jonathan. AU - White, Martha. AU - Dransfield, Mark. AU - Yancey, Steve. AU - Ortega, Hector. PY - 2008/6/1. Y1 - 2008/6/1. N2 - Objective: This long-term prospective study was conducted in African Americans with persistent asthma to examine the safety and effectiveness of the combination of the inhaled corticosteroid, fluticasone propionate (FP), and the long-acting beta-agonist, salmeterol, compared with FP alone. Research and design methods: This was a randomized, double-blind, parallel group, multi-center trial in adolescent and adult subjects ≥12 years of age symptomatic on a low dose of an inhaled corticosteroid (ICS). The study consisted of a 2-week screening period on low dose ICS; a 4-week open-label FP 250 mcg twice daily (BID) run-in; a 52-week double-blind period ...
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COPD patients have challenges for effective use of inhalers due to advanced age, fixed airflow obstruction and comorbid medical conditions. Published clinical trials investigate drug efficacy but rarely consider the inhaler device. This trial investigates device efficacy, comparing clinical outcomes for the same medication via two different devices. Our intention was to communicate the results and to critically appraise the study protocol to inform planning of future device comparison research. Subjects with spirometry confirming at least moderate COPD were randomly assigned to inhaler sequence; starting with Accuhaler or metered dose inhaler and spacer (MDI/s). After baseline testing, subjects were assigned to fluticasone propionate/salmeterol xinafoate (SFC) 500/50 mcg twice daily via the first device for 6 weeks duration, then changed to the alternate device for the following 6 weeks. Subjects were reassessed in terms of health-related quality of life (HRQL), exercise endurance and lung function
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Participants received a single dose of each treatment from Period I - V in the following order, separated by a washout period of 4-7 days: Indacaterol 150 μg (Ind 150μg), Salmeterol/fluticasone 50/500 μg (Salm/flut), Indacaterol 300 μg (Ind 300μg), Placebo, Salbutamol 200 μg (Salbut). At each treatment visit, participants received the specified treatment and 2 placebo inhalations (one inhalation from the SDDPI, and one inhalation from each of the two MDDPIs) to maintain blinding. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study ...