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E Burmeister Getz, K J Carroll, J Mielke, L Z Benet, B Jones
We previously demonstrated pharmacokinetic differences among manufacturing batches of an FDA-approved dry powder inhalation product (Advair Diskus(®) 100/50) large enough to establish between-batch bio-inequivalence. Here, we provide independent confirmation of pharmacokinetic bio-inequivalence among Advair Diskus 100/50 batches, and quantify residual and between-batch variance component magnitudes. These variance estimates are used to consider the Type I error rate of FDA's current two-way crossover design recommendation...
October 11, 2016: Clinical Pharmacology and Therapeutics
John M Weiler, Christine A Sorkness, Leslie Hendeles, Yaping Zhu, Sara Nichols
This was a pilot, randomized, double-blind, crossover, proof-of-concept, clinical endpoint study to examine the hypothesis that exhaled nitric oxide (eNO) in asthmatic subjects can demonstrate bioequivalence of fluticasone propionate in Test and Reference combination products. Subjects had ≥6-month history of asthma and screening eNO was ≥60 parts per billion. eNO was ≥55 parts per billion and forced expiratory volume in 1 second (FEV1) was ≥50% predicted, at start of each treatment period. Subjects presented once each consecutive morning in the clinic during each of three weekly treatment periods to measure eNO and receive once-daily doses of 100/50, 250/50, or 500/50 Advair® combination product...
September 1, 2016: Journal of Clinical Pharmacology
E Burmeister Getz, K J Carroll, B Jones, L Z Benet
Current pharmacokinetic (PK) bioequivalence guidelines do not account for batch-to-batch variability in study design or analysis. Here we evaluate the magnitude of batch-to-batch PK variability for Advair Diskus 100/50. Single doses of fluticasone propionate and salmeterol combinations were administered by oral inhalation to healthy subjects in a randomized clinical crossover study comparing three different batches purchased from the market, with one batch replicated across two treatment periods. All pairwise comparisons between different batches failed the PK bioequivalence statistical test, demonstrating substantial PK differences between batches that were large enough to demonstrate bio-inequivalence in some cases...
September 2016: Clinical Pharmacology and Therapeutics
Matthew Daubresse, Susan Hutfless, Yoonsang Kim, Rachel Kornfield, Dima M Qato, Jidong Huang, Kay Miller, Sherry L Emery, G Caleb Alexander
RATIONALE: The United States is one of only two countries that permit direct-to-consumer advertising (DTCA) of prescription drugs, and many questions remain regarding its effects. OBJECTIVES: To quantify the association between asthma-related DTCA, pharmacy sales, and healthcare use. METHODS: This was an ecological study from 2005 through 2009 using linked data from Nielsen (DTCA television ratings), the IMS Health National Prescription Audit (pharmacy sales), and the MarketScan Commercial Claims data (healthcare use) for 75 designated market areas in the United States...
July 1, 2015: American Journal of Respiratory and Critical Care Medicine
Kathryn Blake, Janet T Holbrook, Holly Antal, David Shade, H Timothy Bunnell, Suzanne M McCahan, Robert A Wise, Chris Pennington, Paul Garfinkel, Tim Wysocki
INTRODUCTION: Phase III/IV clinical trials are expensive and time consuming and often suffer from poor enrollment and retention rates. Pediatric trials are particularly difficult because scheduling around the parent, participant and potentially other sibling schedules can be burdensome. We are evaluating using the internet and mobile devices to conduct the consent process and study visits in a streamlined pediatric asthma trial. Our hypothesis is that these study processes will be non-inferior and will be less expensive compared to a traditional pediatric asthma trial...
May 2015: Contemporary Clinical Trials
Makoto Hoshino, Junichi Ohtawa, Kenta Akitsu
BACKGROUND: Current guidelines recommend combining long-acting bronchodilators with different modes of action in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). We evaluated the effects of airway dimensions and pulmonary function with tiotropium plus indacaterol versus Advair(®). METHODS: Subjects (n = 46) were randomized to receive tiotropium (18 μg once daily) plus indacaterol (150 μg once daily) or Advair(®) (50/250 μg twice daily) for 16 weeks...
February 2015: Pulmonary Pharmacology & Therapeutics
Afisi S Ismaila, Nancy Risebrough, Chunmei Li, Diane Corriveau, Neil Hawkins, J Mark FitzGerald, Zhen Su
OBJECTIVE: To evaluate the cost-utility of the treatment with a long acting beta-agonist (LABA) and inhaled corticosteroid (ICS) combination inhaler [salmeterol xinafoate (SAL)/fluticasone propionate (FP) combination inhaler (SFC) (Advair(®))] to continuing on current ICS dose (no ICS dose change) or increased ICS dose [fluticasone propionate (FP)] in patients with uncontrolled asthma in Canada. METHODS: A cost-utility analysis was conducted from a Canadian public healthcare perspective with a one year time horizon...
September 2014: Respiratory Medicine
Satish Kalanjeri, Hangjun Wang, Andre Moreira, Diane Stover, Robert Lee
SESSION TYPE: ILD Case Report PostersPRESENTED ON: Tuesday, October 23, 2012 at 01:30 PM - 02:30 PMINTRODUCTION: The common histopathologic features of pulmonary sarcoidosis consist of non-caseating, non-necrotizing granulomas with lymph node involvement. The presence of necrotizing granulomas raises concern for infectious or vasculitic processes. Although rare, necrotizing sarcoid granulomatosis (NSG) should be considered in the differential diagnosis. We present a case of NSG.CASE PRESENTATION: A 44 year-old lady with history of breast cancer and bilateral mastectomy in 10/2009 presented in 10/2010 with exertional dyspnea...
October 1, 2012: Chest
Lester I Harrison, Christopher C Novak, Michael J Needham, Paul Ratner
BACKGROUND: This report presents results of the first human study of a new dry powder inhaler (DPI-C). DPI-C uses reverse flow cyclone technology to retain larger particles in the device and to increase efficiency of respirable drug release. The study was conducted to determine comparative pharmacokinetics (not bioequivalence) of DPI-C and DPI-A (Advair Diskus®, GlaxoSmithKline) and to establish preliminary efficacy and safety of DPI-C. METHODS: Nineteen patients with mild-moderate asthma received two treatments (randomized crossover design)...
October 2011: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Piotr Kuna
BACKGROUND: Three fixed maintenance-dose inhaled corticosteroid/long-acting beta(2)-agonist (ICS/LABA) combinations for the treatment of asthma are currently available: salmeterol/fluticasone propionate (Seretide/Advair/Adoair) budesonide/formoterol (Symbicort) and beclometasone/formoterol (Foster). All of these combinations have proven efficacy in terms of controlling symptoms, improving lung function and reducing the rate of exacerbations compared with ICSs and LABAs administered separately...
2010: Clinical Drug Investigation
René Aalbers
BACKGROUND AND OBJECTIVE: Inhaled corticosteroid (ICS)/long-acting beta(2)-agonist (LABA) combinations are the preferred maintenance therapy for adult asthma patients uncontrolled by ICS alone. Supporting data are largely from mixed populations of adolescents and adults, although ICS/LABA combinations are not approved for adolescents in all countries. This analysis evaluates overall asthma control in asthma patients aged >or=16 years receiving ICS/LABA combinations. METHODS: This was a post hoc analysis of asthma patients aged >or=16 years in a randomized, double-blind/open-label extension, parallel-group study...
2010: Clinical Drug Investigation
Stefan Rustscheff, Louise Rydén
Chronic obstructive pulmonary disease (COPD) still poses a formidable challenge to patients and clinicians alike. A fixed-dose dry powder combination inhaler, Seretide/Advair, containing salmeterol and fluticasone, is licensed in the European Community for the treatment of moderate to severe COPD in the strength of 50/500 microg twice daily (BID). Several studies have investigated the effects of this combination and show improved forced expiratory volume in 1 s (FEV(1)), quality of life, and a decrease of exacerbations...
March 2010: Journal of Asthma: Official Journal of the Association for the Care of Asthma
Benoit Tano, Dev Pathak, Stephen Hoffmann
The National Heart, Lung and Blood Institute guidelines for the treatment of asthma suggest that inhaled corticosteroids, with the addition of a long-acting bronchodilator, may be the most effective long-term control medication for asthma. Five inhaled corticosteroids are approved for use in the USA, including beclomethasone dipropionate, budesonide, flunisolide, triamcinolone acetonide and fluticasone propionate. Fluticasone propionate (Flixotide) and the long-acting beta2 agonist salmeterol (Serevent), are now available in the USA together in an easy to use dry powder inhaler Advair...
December 2003: Expert Review of Pharmacoeconomics & Outcomes Research
Kate McKeage, Susan J Keam
Salmeterol/fluticasone propionate (Seretide/Advair Diskus [dry powder inhaler] or Seretide/Advair inhalation aerosol [metered-dose inhaler]) is a fixed-dose combination inhalation agent containing a long-acting beta2-adrenoceptor agonist (LABA) plus a corticosteroid. In patients with symptomatic asthma, twice-daily salmeterol/fluticasone propionate maintenance therapy improves lung function and asthma symptoms to a greater extent than monotherapy with inhaled corticosteroids (ICS), such as fluticasone propionate, oral montelukast with or without fluticasone propionate, or sustained-release theophylline plus fluticasone propionate...
2009: Drugs
Leandro Fritscher, Kenneth R Chapman
BACKGROUND: The costs of asthma and chronic obstructive pulmonary disease (COPD), the two most common chronic respiratory illnesses, are substantial and rising. The fixed-dose combination of fluticasone and salmeterol has been a safe and effective therapy for these diseases. OBJECTIVES: To review the pharmacoeconomic impact of the fixed-dose combination of inhaled fluticasone and salmeterol in asthma and COPD. METHODS: A systematic review of the literature was carried out to identify pharmacoeconomic studies with fixed-dose salmeterol and fluticasone (Seretide, Advair, Viani)...
2008: Journal of Medical Economics
Matthew Peters
When an adequate standard of asthma control is not achieved with maintenance treatment of inhaled corticosteroids, the addition of a long-acting beta(2)-adrenergic receptor agonist (LABA) bronchodilator is recommended. Using a combination product, salmeterol/fluticasone propionate (Seretide or Advair) or budesonide/formoterol (Symbicort) is preferred for convenience and avoids any risk that LABA might be used as monotherapy. As formoterol has a rapid onset of bronchodilator effect, the budesonide/formoterol combination can be used for both the maintenance and reliever components of asthma treatment (Symbicort SMART) and this is endorsed as an effective treatment by the Global Initiative for Asthma...
2009: Drugs
Anthony New, Dave Prime, Simeone Zomer, David Elder, Robert Donovan, Evelyn Freney
Aerosol Time-of-Flight Mass Spectrometry (AToFMS) was used to examine co-association between two inhaled drugs, fluticasone propionate (FP) and salmeterol xinofoate (SX), in fine aerosolised particles emitted from Seretide(R)/Advair(R) inhaled combination products. Principal Component Analysis (PCA) was used to identify fragmentation patterns indicative of either pure or co-associated particles (particles containing both drugs). A third component of the particles emitted from dry powder inhalers (DPIs), lactose, gave only a very weak mass spectral signal and no interpretable data was acquired for this compound; however, it was not found to interfere with the detection of the two drug substances...
December 2008: Rapid Communications in Mass Spectrometry: RCM
Sarah L Cutrona, Steffie Woolhandler, Karen E Lasser, David H Bor, David U Himmelstein, William H Shrank, Neal S LeLeiko
OBJECTIVES: Free drug samples frequently are given to children. We sought to describe characteristics of free sample recipients, to determine whether samples are given primarily to poor and uninsured children, and to examine potential safety issues. METHODS: We analyzed data on 10295 US residents <18 years of age from the 2004 Medical Expenditure Panel Survey, a nationally representative survey that includes questions on receipt of free drug samples. We performed bivariate and multivariate analyses to evaluate characteristics associated with receipt of >or=1 free drug sample in 2004...
October 2008: Pediatrics
Don D Sin, S F Paul Man, Darcy D Marciniuk, Gordon Ford, Mark FitzGerald, Eric Wong, Ernest York, Rajesh R Mainra, Warren Ramesh, Lyle S Melenka, Eric Wilde, Robert L Cowie, Dave Williams, Wen Q Gan, Roxanne Rousseau
RATIONALE: Small studies have suggested that inhaled corticosteroids can suppress systemic inflammation in chronic obstructive pulmonary disease (COPD). OBJECTIVES: To determine the effect of inhaled corticosteroids with or without long-acting beta(2)-adrenergic agonist on systemic biomarkers of inflammation. METHODS: We conducted a double-blind randomized placebo-controlled trial across 11 centers (n = 289 patients with FEV(1) of 47.8 +/- 16...
June 1, 2008: American Journal of Respiratory and Critical Care Medicine
Gillian M Keating, Paul L McCormack
Salmeterol/fluticasone propionate (Seretide, Advair, Viani) administered using a multidose dry powder inhaler (Diskus, Accuhaler) is approved for use in the treatment of chronic obstructive pulmonary disease (COPD) in numerous countries.Salmeterol/fluticasone propionate administered twice daily via dry powder inhaler is effective and generally well tolerated in patients with COPD. Although not associated with a statistically significant reduction in mortality versus placebo in the TORCH study (p = 0.052), salmeterol/fluticasone propionate reduced the rate of decline in lung function over the 3 years of the trial and was associated with lower exacerbation rates than the component monotherapies or placebo; other trials revealed clinically significant improvements in health status and dyspnoea scores with salmeterol/fluticasone propionate...
2007: Drugs
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