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1 Effect of Indacaterol, a Novel Long-Acting Beta 2
ERJ Express. Published on November 29, 2006 as doi: 10.1183/09031936.00032806 EFFECT OF INDACATEROL, A NOVEL LONG-ACTING BETA 2-AGONIST, ON HUMAN ISOLATED BRONCHI Emmanuel Naline (1), Alexandre Trifilieff (2), Robin A. Fairhurst (2), Charles Advenier (1), Mathieu Molimard (3) (1) Research Unit EA220, Université de Versailles, Faculté de Médecine, Pharmacology, Hôpital Foch, 40 rue Worth, 92150 Suresnes, France (2) Novartis Institute for BioMedical Research, Horsham, England (3) Département de Pharmacologie, Université Victor Segalen Bordeaux 2; CHU Pellegrin; INSERM U657, Bordeaux, France Correspondence: Mathieu Molimard Département de Pharmacologie CHU de Bordeaux - Université Victor Segalen-INSERM U657 33076 Bordeaux cedex, France Phone: 33 (0)5 57 57 15 60 Fax: 33 (0)5 57 57 46 71 E-mail: [email protected] Short title: Indacaterol effect on isolated human bronchi 1 Copyright 2006 by the European Respiratory Society. Abstract Indacaterol is a novel β2-adrenoceptor agonist in development for the once-daily treatment of asthma and COPD. This study evaluated the relaxant effect of indacaterol on isolated human bronchi obtained from lungs of patients undergoing surgery for lung carcinoma. Potency (-logEC50), intrinsic efficacy (Emax) and onset of action were determined at resting tone. Duration of action was determined against cholinergic neural contraction induced by electrical field stimulation (EFS). At resting tone, -logEC50 and Emax values were, respectively, 8.82±0.41 and 77±5% for indacaterol, 9.84±0.22 and 94±1% for formoterol, 8.36±0.16 and 74±4% for salmeterol, and 8.43±0.22 and 84±4% for salbutamol. In contrast to salmeterol, indacaterol did not antagonize the isoprenaline response. -
Us Anti-Doping Agency
2019U.S. ANTI-DOPING AGENCY WALLET CARDEXAMPLES OF PROHIBITED AND PERMITTED SUBSTANCES AND METHODS Effective Jan. 1 – Dec. 31, 2019 CATEGORIES OF SUBSTANCES PROHIBITED AT ALL TIMES (IN AND OUT-OF-COMPETITION) • Non-Approved Substances: investigational drugs and pharmaceuticals with no approval by a governmental regulatory health authority for human therapeutic use. • Anabolic Agents: androstenediol, androstenedione, bolasterone, boldenone, clenbuterol, danazol, desoxymethyltestosterone (madol), dehydrochlormethyltestosterone (DHCMT), Prasterone (dehydroepiandrosterone, DHEA , Intrarosa) and its prohormones, drostanolone, epitestosterone, methasterone, methyl-1-testosterone, methyltestosterone (Covaryx, EEMT, Est Estrogens-methyltest DS, Methitest), nandrolone, oxandrolone, prostanozol, Selective Androgen Receptor Modulators (enobosarm, (ostarine, MK-2866), andarine, LGD-4033, RAD-140). stanozolol, testosterone and its metabolites or isomers (Androgel), THG, tibolone, trenbolone, zeranol, zilpaterol, and similar substances. • Beta-2 Agonists: All selective and non-selective beta-2 agonists, including all optical isomers, are prohibited. Most inhaled beta-2 agonists are prohibited, including arformoterol (Brovana), fenoterol, higenamine (norcoclaurine, Tinospora crispa), indacaterol (Arcapta), levalbuterol (Xopenex), metaproternol (Alupent), orciprenaline, olodaterol (Striverdi), pirbuterol (Maxair), terbutaline (Brethaire), vilanterol (Breo). The only exceptions are albuterol, formoterol, and salmeterol by a metered-dose inhaler when used -
COPD Agents Review – October 2020 Page 2 | Proprietary Information
COPD Agents Therapeutic Class Review (TCR) October 1, 2020 No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, recording, digital scanning, or via any information storage or retrieval system without the express written consent of Magellan Rx Management. All requests for permission should be mailed to: Magellan Rx Management Attention: Legal Department 6950 Columbia Gateway Drive Columbia, Maryland 21046 The materials contained herein represent the opinions of the collective authors and editors and should not be construed to be the official representation of any professional organization or group, any state Pharmacy and Therapeutics committee, any state Medicaid Agency, or any other clinical committee. This material is not intended to be relied upon as medical advice for specific medical cases and nothing contained herein should be relied upon by any patient, medical professional or layperson seeking information about a specific course of treatment for a specific medical condition. All readers of this material are responsible for independently obtaining medical advice and guidance from their own physician and/or other medical professional in regard to the best course of treatment for their specific medical condition. This publication, inclusive of all forms contained herein, is intended to be educational in nature and is intended to be used for informational purposes only. Send comments and suggestions to [email protected]. October 2020 -
Analysis of the Indacaterol-Regulated Transcriptome in Human Airway
Supplemental material to this article can be found at: http://jpet.aspetjournals.org/content/suppl/2018/04/13/jpet.118.249292.DC1 1521-0103/366/1/220–236$35.00 https://doi.org/10.1124/jpet.118.249292 THE JOURNAL OF PHARMACOLOGY AND EXPERIMENTAL THERAPEUTICS J Pharmacol Exp Ther 366:220–236, July 2018 Copyright ª 2018 by The American Society for Pharmacology and Experimental Therapeutics Analysis of the Indacaterol-Regulated Transcriptome in Human Airway Epithelial Cells Implicates Gene Expression Changes in the s Adverse and Therapeutic Effects of b2-Adrenoceptor Agonists Dong Yan, Omar Hamed, Taruna Joshi,1 Mahmoud M. Mostafa, Kyla C. Jamieson, Radhika Joshi, Robert Newton, and Mark A. Giembycz Departments of Physiology and Pharmacology (D.Y., O.H., T.J., K.C.J., R.J., M.A.G.) and Cell Biology and Anatomy (M.M.M., R.N.), Snyder Institute for Chronic Diseases, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada Received March 22, 2018; accepted April 11, 2018 Downloaded from ABSTRACT The contribution of gene expression changes to the adverse and activity, and positive regulation of neutrophil chemotaxis. The therapeutic effects of b2-adrenoceptor agonists in asthma was general enriched GO term extracellular space was also associ- investigated using human airway epithelial cells as a therapeu- ated with indacaterol-induced genes, and many of those, in- tically relevant target. Operational model-fitting established that cluding CRISPLD2, DMBT1, GAS1, and SOCS3, have putative jpet.aspetjournals.org the long-acting b2-adrenoceptor agonists (LABA) indacaterol, anti-inflammatory, antibacterial, and/or antiviral activity. Numer- salmeterol, formoterol, and picumeterol were full agonists on ous indacaterol-regulated genes were also induced or repressed BEAS-2B cells transfected with a cAMP-response element in BEAS-2B cells and human primary bronchial epithelial cells by reporter but differed in efficacy (indacaterol $ formoterol . -
Long-Acting Beta-Agonists in the Management of Chronic Obstructive Pulmonary Disease: Current and Future Agents
UCLA UCLA Previously Published Works Title Long-acting beta-agonists in the management of chronic obstructive pulmonary disease: current and future agents Permalink https://escholarship.org/uc/item/7s74p6sc Journal Respiratory Research, 11(1) ISSN 1465-9921 Authors Tashkin, Donald P Fabbri, Leonardo M Publication Date 2010-10-29 DOI http://dx.doi.org/10.1186/1465-9921-11-149 Peer reviewed eScholarship.org Powered by the California Digital Library University of California Tashkin and Fabbri Respiratory Research 2010, 11:149 http://respiratory-research.com/content/11/1/149 REVIEW Open Access Long-acting beta-agonists in the management of chronic obstructive pulmonary disease: current and future agents Donald P Tashkin1*, Leonardo M Fabbri2 Abstract Chronic obstructive pulmonary disease (COPD) is characterized by progressive airflow limitation and debilitating symptoms. For patients with moderate-to-severe COPD, long-acting bronchodilators are the mainstay of therapy; as symptoms progress, guidelines recommend combining bronchodilators from different classes to improve efficacy. Inhaled long-acting b2-agonists (LABAs) have been licensed for the treatment of COPD since the late 1990s and include formoterol and salmeterol. They improve lung function, symptoms of breathlessness and exercise limita- tion, health-related quality of life, and may reduce the rate of exacerbations, although not all patients achieve clini- cally meaningful improvements in symptoms or health related quality of life. In addition, LABAs have an acceptable safety profile, and are not associated with an increased risk of respiratory mortality, although adverse effects such as palpitations and tremor may limit the dose that can be tolerated. Formoterol and salmeterol have 12-hour durations of action; however, sustained bronchodilation is desirable in COPD. -
Medicines for COPD
American Thoracic Society PATIENT EDUCATION | INFORMATION SERIES Medicines for COPD Chronic obstructive pulmonary disease (COPD) is a chronic disease of the lungs that damages both the airways and the lung tissue, making it difficult to breathe. A person with COPD may have obstructive bronchiolitis (bron-kee-oh-lite-is), emphysema, or a combination of both conditions. People with COPD often use several kinds of medicines to help control symptoms. While there is no cure, medicines can help improve your quality of life. This fact sheet explains different types of medicines used for COPD. For more information on COPD, see the ATS Patient Information Series at www.thoracic.org/patients. BRONCHODILATORS These side effects often last for only a few minutes after taking the Bronchodilators are medications that relax the muscles that wrap medicine and may totally go away after a few days of regular use. around your breathing tubes (airways), allowing the tubes to If the side effects do not go away, talk to your healthcare provider. become larger and easier to breathe through. Each bronchodilator You may need to try a lower dose, change to another type or brand is different, based on its: 1) chemical make-up, 2) how fast it works, of beta2-agonist, or stop the beta2-agonist. If you have difficulty and 3) how long it lasts. Your healthcare provider will decide with going to sleep after taking your beta2-agonist, take it an hour or you which of these medications or combinations work best for you. two before bedtime. Types of bronchodilators: Anticholinergics ■■ beta2-agonists Anticholinergic bronchodilators are also inhaled medicines. -
Indacaterol/Glycopyrronium Versus Salmeterol/Fluticasone in the Prevention of Clinically Important Deterioration in COPD: Results from the FLAME Study Antonio R
Anzueto et al. Respiratory Research (2018) 19:121 https://doi.org/10.1186/s12931-018-0830-z RESEARCH Open Access Indacaterol/glycopyrronium versus salmeterol/fluticasone in the prevention of clinically important deterioration in COPD: results from the FLAME study Antonio R. Anzueto1*, Konstantinos Kostikas2, Karen Mezzi2, Steven Shen3, Michael Larbig2, Francesco Patalano2, Robert Fogel3, Donald Banerji3 and Jadwiga A. Wedzicha4 Abstract Background: Chronic obstructive pulmonary disease (COPD) is a progressive disease and a composite endpoint could be an indicator of treatment effect on disease worsening. This post-hoc analysis assessed whether indacaterol/glycopyrronium (IND/GLY) 110/50 μg once daily reduced the risk of clinically important deterioration (CID) versus salmeterol/fluticasone (SFC) 50/500 μg twice daily in moderate-to-very severe COPD patients from the FLAME study. Methods: CID was defined as ≥100 mL decrease in forced expiratory volume in 1 s (FEV1)or≥ 4-unit increase in St. George’s Respiratory Questionnaire (SGRQ) total score or a moderate-to-severe COPD exacerbation. Changes from baseline in the rate of moderate and severe exacerbations, time to first moderate-to-severe exacerbation, and change from baseline in the SGRQ score, measured after Week 12 up to Week 52, were assessed by presence of early CID (CID+) or absence of CID (CID−) at Week 12. Results: IND/GLY significantly delayed the time to CID (hazard ratio [HR] (95% confidence interval [CI]), 0.72 [0.67–0.78]; P < 0.0001), and reduced the incidences of CID versus SFC. Additionally, IND/GLY delayed the time to CID in all patient subgroups. After 12 weeks until 52 weeks, CID+ patients had a significantly higher rate of moderate-to-severe exacerbations versus CID− patients (P < 0.0001); moreover, CID+ patients experienced moderate-to-severe exacerbations significantly earlier versus CID− patients (P < 0.0001). -
Formoterol Versus Salmeterol/Fluticasone: a Phase 3 COPD Study
ERJ Express. Published on August 4, 2016 as doi: 10.1183/13993003.00216-2016 ORIGINAL ARTICLE IN PRESS | CORRECTED PROOF Efficacy and safety of aclidinium/ formoterol versus salmeterol/fluticasone: a phase 3 COPD study Claus Vogelmeier1, Pier Luigi Paggiaro2, Jordi Dorca3, Pawel Sliwinski4, Marcel Mallet5, Anne-Marie Kirsten6, Jutta Beier7, Beatriz Seoane8, Rosa Maria Segarra8 and Anne Leselbaum9 Affiliations: 1Dept of Medicine, Pulmonary and Critical Care Medicine, University Medical Center Giessen and Marburg, Member of the German Center for Lung Research (DZL), Philipps-University Marburg, Marburg, Germany. 2Respiratory Pathophysiology, University Hospital of Pisa, Pisa, Italy. 3Hospital Universitari de Bellvitge, University of Barcelona, and Institut d’Investigació Biomèdica de Bellvitge (IDIBELL), Barcelona, Spain. 42nd Dept of Respiratory Medicine, Institute of Tuberculosis and Lung Diseases, Warsaw, Poland. 5Moncton Respirology Clinic, Moncton, NB, Canada. 6Pulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North, Member of the Germany Center for Lung Research (DZL), Grosshansdorf, Germany. 7insaf Respiratory Research Institute, Wiesbaden, Germany. 8AstraZeneca, Barcelona, Spain. 9Almirall SA, Barcelona, Spain. Correspondence: Claus Vogelmeier, Universitätsklinikum Gießen und Marburg, Standort Marburg, Baldingerstraße, D-35043 Marburg, Germany. E-mail: [email protected] ABSTRACT The efficacy and safety of twice-daily aclidinium bromide/formoterol fumarate was compared with that of salmeterol/fluticasone propionate in patients with stable, moderate-to-severe chronic obstructive pulmonary disease (COPD). AFFIRM COPD (Aclidinium and Formoterol Findings in Respiratory Medicine COPD) was a 24-week, double-blind, double-dummy, active-controlled study. Patients were randomised (1:1) to aclidinium/ formoterol 400/12 µg twice-daily via Genuair/Pressair or salmeterol/fluticasone 50/500 µg twice-daily via Accuhaler. -
Pharmacology and Therapeutics of Bronchodilators
1521-0081/12/6403-450–504$25.00 PHARMACOLOGICAL REVIEWS Vol. 64, No. 3 Copyright © 2012 by The American Society for Pharmacology and Experimental Therapeutics 4580/3762238 Pharmacol Rev 64:450–504, 2012 ASSOCIATE EDITOR: DAVID R. SIBLEY Pharmacology and Therapeutics of Bronchodilators Mario Cazzola, Clive P. Page, Luigino Calzetta, and M. Gabriella Matera Department of Internal Medicine, Unit of Respiratory Clinical Pharmacology, University of Rome ‘Tor Vergata,’ Rome, Italy (M.C., L.C.); Department of Pulmonary Rehabilitation, San Raffaele Pisana Hospital, Istituto di Ricovero e Cura a Carattere Scientifico, Rome, Italy (M.C., L.C.); Sackler Institute of Pulmonary Pharmacology, Institute of Pharmaceutical Science, King’s College London, London, UK (C.P.P., L.C.); and Department of Experimental Medicine, Unit of Pharmacology, Second University of Naples, Naples, Italy (M.G.M.) Abstract............................................................................... 451 I. Introduction: the physiological rationale for using bronchodilators .......................... 452 II. -Adrenergic receptor agonists .......................................................... 455 A. A history of the development of -adrenergic receptor agonists: from nonselective  Downloaded from adrenergic receptor agonists to 2-adrenergic receptor-selective drugs.................... 455  B. Short-acting 2-adrenergic receptor agonists........................................... 457 1. Albuterol........................................................................ 457 -
Chronic Obstructiv Chronic Obstructive Pulmonary Disease
pat hways Chronic obstructive pulmonary disease: beclometasone, formoterol and glycopyrronium (Trimbow) Evidence summary Published: 3 May 2018 nice.org.uk/guidance/es17 Key points The content of this evidence summary was up-to-date in May 2018. See summaries of product characteristics (SPCs), British national formulary (BNF) or the Medicines and Healthcare products Regulatory Agency (MHRA) or NICE websites for up-to-date information. Regulatory status: Beclometasone/formoterol/glycopyrronium (Trimbow, Chiesi Limited) received a European marketing authorisation in July 2017. This triple-therapy inhaler contains an inhaled corticosteroid (ICS), long-acting beta-2 agonist (LABA) and long-acting muscarinic antagonist (LAMA). It is licensed for maintenance treatment of adults with moderate-to-severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an ICS and a LABA. Overview This evidence summary discusses 3 randomised controlled trials (TRILOGY, TRINITY and TRIBUTE) looking at the safety and efficacy of beclometasone/formoterol/glycopyrronium in people with COPD with severe or very severe airflow limitation, symptoms despite treatment and a history of exacerbations. © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 1 of conditions#notice-of-rights). 78 Chronic obstructive pulmonary disease: beclometasone, formoterol and glycopyrronium (Trimbow) (ES17) Overall, the studies found small, statistically significant improvements in lung function, rates of moderate-to-severe exacerbations of COPD and health-related quality-of-life scores with beclometasone/formoterol/glycopyrronium compared with beclometasone/formoterol or indacaterol/glycopyrronium dual therapy, or tiotropium alone. The improvements may be of limited clinical importance. In TRILOGY and TRINITY, improvements in primary outcomes relating to lung function and exacerbation rates just reached the level considered to be clinically important. -
TRELEGY ELLIPTA Safely and Effectively
HIGHLIGHTS OF PRESCRIBING INFORMATION • Hypercorticism and adrenal suppression may occur with very high These highlights do not include all the information needed to use dosages or at the regular dosage in susceptible individuals. If such TRELEGY ELLIPTA safely and effectively. See full prescribing changes occur, discontinue TRELEGY ELLIPTA slowly. (5.8) information for TRELEGY ELLIPTA. • If paradoxical bronchospasm occurs, discontinue TRELEGY ELLIPTA and institute alternative therapy. (5.10) TRELEGY ELLIPTA (fluticasone furoate, umeclidinium, and vilanterol • Use with caution in patients with cardiovascular disorders because of inhalation powder), for oral inhalation use beta-adrenergic stimulation. (5.12) Initial U.S. Approval: 2017 • Assess for decrease in bone mineral density initially and periodically --------------------------- RECENT MAJOR CHANGES --------------------------- thereafter. (5.13) Indications and Usage, Maintenance Treatment of Asthma (1.2) 9/2020 • Glaucoma and cataracts may occur with long-term use of ICS. Worsening Dosage and Administration, Recommended Dosage for 9/2020 of narrow-angle glaucoma may occur. Use with caution in patients with Maintenance Treatment of Asthma (2.3) narrow-angle glaucoma and instruct patients to contact a healthcare Contraindications (4) 9/2020 provider immediately if symptoms occur. Consider referral to an Warnings and Precautions, Serious Asthma-Related Events – 9/2020 ophthalmologist in patients who develop ocular symptoms or use Hospitalizations, Intubations, Death (5.1) TRELEGY ELLIPTA long term. (5.14) Warnings and Precautions, Effect on Growth (5.18) 9/2020 • Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct --------------------------- INDICATIONS AND USAGE ---------------------------- patients to contact a healthcare provider immediately if symptoms occur. -
Fluticasone Furoate, Umeclidinium and Vilanterol (Trelegy)
pat hways Chronic obstructive pulmonary disease: fluticasone furoate, umeclidinium and vilanterol (Trelegy) Evidence summary Published: 14 June 2018 nice.org.uk/guidance/es18 Key points The content of this evidence summary was up-to-date in June 2018. See summaries of product characteristics (SPC), British national formulary (BNF) or the MHRA or NICE websites for up- to-date information. Regulatory status: Fluticasone furoate/umeclidinium/vilanterol (Trelegy, GlaxoSmithKline UK) received a European marketing authorisation in November 2017. This triple-therapy inhaler contains an inhaled corticosteroid (ICS), long-acting beta-2 agonist (LABA) and long-acting muscarinic antagonist (LAMA). It is licensed for maintenance treatment of adults with moderate- to-severe chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an ICS and a LABA (summary of product characteristics). Overview This evidence summary discusses 2 randomised controlled trials (RCTs) looking at the safety and efficacy of fluticasone furoate/umeclidinium/vilanterol (an ICS/LAMA and LABA combination inhaler) in people with COPD who were symptomatic despite regular maintenance treatment and who either had a history, or were at risk, of exacerbations. © NICE 2018. All rights reserved. Subject to Notice of rights (https://www.nice.org.uk/terms-and- Page 1 of conditions#notice-of-rights). 54 Chronic obstructive pulmonary disease: fluticasone furoate, umeclidinium and vilanterol (Trelegy) (ES18) Fluticasone furoate/umeclidinium/vilanterol (Trelegy) is licensed for maintenance treatment of adults with moderate-to severe COPD who are not adequately treated by a combination of an ICS and a LABA. Fluticasone furoate/umeclidinium/vilanterol has been shown to reduce the annual rate of moderate or severe exacerbations by 15% compared with fluticasone furoate/vilanterol.