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Julia Paik, Lesley J Scott, Roy A Pleasants
The novel, easy-to-use, breath-actuated fluticasone propionate/salmeterol multidose dry powder inhaler (MDPI) (AirDuo RespiClick® ) was recently approved in the USA for twice-daily treatment of asthma in patients aged ≥ 12 years. This inhaled corticosteroid (ICS) and long-acting β2 -adrenoreceptor agonist (LABA) combination treatment is available in low-, mid- and high-dosage formulations (55/14, 113/14 and 232/14 μg, respectively). In 12-week, phase III trials in patients aged ≥ 12 years with persistent asthma, all three dosages of fluticasone propionate/salmeterol MDPI treatment produced significant improvements in lung function and other asthma symptoms compared with fluticasone propionate MDPI monotherapy or placebo MDPI...
March 26, 2018: Clinical Drug Investigation
John M Weiler, Christine A Sorkness, Leslie Hendeles, Sara Nichols, Yaping Zhu
This was a randomized, double-blind, crossover, clinical-end-point pilot study examining the hypothesis that inhaled fluticasone propionate decreases exhaled nitric oxide (eNO) concentrations within a week of beginning treatment and shows evidence of dose separation across the marketed dose range. Subjects had a ≥6-month history of asthma and screening eNO ≥60 parts per billion. At the start of each treatment period, eNO was ≥55 parts per billion, and forced expiratory volume in 1 second was ≥50% predicted...
November 28, 2017: Journal of Clinical Pharmacology
Kristen Kiernicki, Donald W Helme
Although direct-to-consumer (DTC) prescription drug advertising is regulated by the U.S. Food and Drug Administration, content analyses suggest advertisers may not disclose drug risks in the same way they describe drug benefits. This study tests the relationship between image congruency in televised DTC advertisements, recall of risks/benefits, and perceived persuasiveness. Advertisements for Nasonex, Advair, and Lunesta were shown to college students in either their original (image incongruent) or modified (image neutral) form...
October 2017: Health Marketing Quarterly
Martin W Jetzer, Bradley D Morrical, David P Fergenson, Georgios Imanidis
Particle co-associations between the active pharmaceutical ingredients fluticasone propionate and salmeterol xinafoate were examined in dry powder inhaled (DPI) and metered dose inhaled (MDI) combination products. Single Particle Aerosol Mass Spectrometry was used to investigate the particle interactions in Advair Diskus(®) (500/50 mcg) and Seretide(®) (125/25 mcg). A simple rules tree was used to identify each compound, either alone or co-associated at the level of the individual particle, using unique marker peaks in the mass spectra for the identification of each drug...
August 31, 2017: International Journal of Pharmaceutics
Jeffrey T Kullgren, Joel E Segel, Timothy A Peterson, A Mark Fendrick, Simone Singh
OBJECTIVES: To examine how often retail prices for prescription drugs are available on state public reporting websites, the variability of these reported prices, and zip code characteristics associated with greater price variation. STUDY DESIGN: Searches of state government-operated websites in Michigan, Missouri, New York, and Pennsylvania for retail prices for Advair Diskus (250/50 fluticasone propionate/salmeterol), Lyrica (pregabalin 50 mg), Nasonex (mometasone 50 mcg nasal spray), Spiriva (tiotropium 18 mcg cp-handihaler), Zetia (ezetimibe 10 mg), atorvastatin 20 mg, and metoprolol 50 mg...
July 2017: American Journal of Managed Care
Anne C Melzer, Bijan J Ghassemieh, Suzanne E Gillespie, Peter K Lindenauer, Mary Ann McBurnie, Richard A Mularski, Edward T Naureckas, William M Vollmer, David H Au
BACKGROUND: Inhaled therapies are the cornerstone of pharmacologic management for COPD. Each device requires a unique series of steps to be most effective, making appropriate instruction in inhaler technique a key part of the management of COPD. OBJECTIVES: Examine characteristics of patients and devices associated with poor technique among patients with COPD. METHODS: Cross-sectional study of subjects with COPD using at least one of: metered dose inhaler, Advair Diskus, Spiriva Handihaler, identified from the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT) registry...
February 2017: Respiratory Medicine
Malinda V Longphre, Elise Burmeister Getz, Rick Fuller
RATIONALE: OT329 SOLIS is a generic candidate for the branded asthma treatment, ADVAIR DISKUS (fluticasone propionate/salmeterol xinafoate), and, as such, the manufacturer is required to provide evidence of clinical "bioequivalence" as a condition for regulatory approval. OBJECTIVES: The objective of the current study was to determine if SOLIS and DISKUS provided bioequivalent improvements in lung function at two time points: Day 1 and Week 4. METHODS: This study was a randomized, multiple-dose, placebo-controlled, parallel-group design conducted in the United States (NCT02260492) with a 2-week run-in followed by a 4-week treatment period...
February 2017: Annals of the American Thoracic Society
E Burmeister Getz, K J Carroll, J Mielke, L Z Benet, B Jones
We previously demonstrated pharmacokinetic differences among manufacturing batches of a US Food and Drug Administration (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 the FDA's current two-way crossover design recommendation...
March 2017: Clinical Pharmacology and Therapeutics
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January 2017: 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
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