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The management of symptoms of chronic obstructive pulmonary disease (COPD) typically involves the use of inhaled long-acting bronchodilators. Previously, we have reviewed the long-acting muscarinic antagonists (LAMAs) ▼aclidinium,(1) ▼glycopyrronium,(2) tiotropium(3) and ▼umeclidinium,(4) and the long-acting beta2 agonists (LABAs) indacaterol,(5) ▼olodaterol,(6) and ▼vilanterol (in combination with fluticasone) in the management of COPD.(7) Four fixed-dose combinations of a LAMA with a LABA are now available, all indicated as maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD...
January 5, 2017: Drug and Therapeutics Bulletin
Mark A Mastrodicasa, Christopher A Droege, Aaron M Mulhall, Neil E Ernst, Ralph J Panos, Muhammad A Zafar
Long acting muscarinic receptor antagonists (LAMA) reverse airflow obstruction by antagonizing para-sympathetic bronchoconstricting effects within the airways. For years, tiotropium, has been the cornerstone LAMA for chronic obstructive pulmonary disease (COPD) management. Recently, new agents, aclidinium bromide, glycopyrronium bromide, and umeclidinium bromide, have been developed and introduced into clinical practice. Areas Covered: This article reviews the clinical efficacy and adverse effects of currently available LAMAs in COPD treatment as well as developing LAMAs in early clinical trials and preclinical studies (V0162, TD-4208, CHF 5407, AZD9164, AZD8683, bencycloquidium)...
December 22, 2016: Expert Opinion on Investigational Drugs
R Yagudina, A Kulikov, E Makarova
No abstract text is available yet for this article.
November 2016: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Timothy E Albertson, James A Chenoweth, Jason Y Adams, Mark E Sutter
Parasympathetic neurons utilize the neurotransmitter acetylcholine to modulate and constrict airway smooth muscles at the muscarinic acetylcholine receptor. Inhaled agents that antagonize the muscarinic (M) acetylcholine receptor, particularly airway M3 receptors, have increasing data supporting use in persistent asthma. Areas covered: Use of inhaled long-acting muscarinic antagonists (LAMA) in asthma is explored. The LAMA tiotropium is approved for maintenance in symptomatic asthma patients despite the use of inhaled corticosteroids (ICS), leukotriene receptor antagonists (LTRA) and/or long-acting beta2 agonists (LABA)...
January 2017: Expert Opinion on Investigational Drugs
Abigail Tebboth, Andrew Ternouth, Nuria Gonzalez-Rojas
OBJECTIVE: The aim of this study is to assess the cost-effectiveness of other long-acting muscarinic antagonist + long-acting β2 agonist combinations in comparison with Spiolto(®) Respimat(®) (tiotropium + olodaterol fixed-dose combination [FDC]) for maintenance treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease. METHODS: A previously published individual-level Markov model was adapted for the perspective of the UK health care system, in line with recommendations from the National Institute for Health and Care Excellence...
2016: ClinicoEconomics and Outcomes Research: CEOR
Javier Milara, Angela Cervera, Alfredo de Diego, Celia Sanz, Gustavo Juan, Amadeu Gavaldà, Montserrat Miralpeix, Esteban Morcillo, Julio Cortijo
BACKGROUND: Inhaled corticosteroid (ICS) with long-acting beta-2 agonists is a well-documented combination therapy for chronic obstructive pulmonary disease (COPD) based on its additive anti-inflammatory properties. By contrast, the recommendation of ICS in combination with long-acting muscarinic antagonist (LAMA) is not evidence-based. In this study, neutrophils obtained from COPD patients were used to compare the anti-inflammatory effects of aclidinium bromide (a long-acting muscarinic antagonist) with corticosteroids and their potential additive effect...
November 8, 2016: Respiratory Research
Maria Gabriella Matera, Mario Cazzola
Parasympathetic activity is increased in patients with chronic obstructive pulmonary disease (COPD) and asthma and appears to be the major reversible component of airway obstruction. Therefore, treatment with muscarinic receptor antagonists is an effective bronchodilator therapy in COPD and also in asthmatic patients. In recent years, the accumulating evidence that the cholinergic system controls not only contraction by airway smooth muscle but also the functions of inflammatory cells and airway epithelial cells has suggested that muscarinic receptor antagonists could exert other effects that may be of clinical relevance when we must treat a patient suffering from COPD or asthma...
October 28, 2016: Handbook of Experimental Pharmacology
Mafalda Ramos, John Haughney, Nathaniel Henry, Leandro Lindner, Mark Lamotte
PURPOSE: Aclidinium-formoterol 400/12 µg is a long-acting muscarinic antagonist (LAMA) and a long-acting β2-agonist in a fixed-dose combination used in the management of patients with COPD. This study aimed to assess the cost-effectiveness of aclidinium-formoterol 400/12 µg against the long-acting muscarinic antagonist aclidinium bromide 400 µg. MATERIALS AND METHODS: A five-health-state Markov transition model with monthly cycles was developed using MS Excel to simulate patients with moderate-to-severe COPD and their initial lung-function improvement following treatment with aclidinium-formoterol 400/12 µg or aclidinium 400 µg...
2016: ClinicoEconomics and Outcomes Research: CEOR
Marc Miravitlles, Kenneth R Chapman, Ferran Chuecos, Anna Ribera, Esther Garcia Gil
BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) experience respiratory symptoms, which impair quality of life. This pooled analysis of two Phase III studies assessed the impact of aclidinium/formoterol on patients with COPD categorized by symptom status. METHODS: Data were pooled from two 24-week, randomized, placebo-controlled studies of twice-daily aclidinium/formoterol 400/12 µg in moderate-to-severe COPD (ACLIFORM [NCT01462942] and AUGMENT [NCT01437397])...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Claus Vogelmeier, Pier Luigi Paggiaro, Jordi Dorca, Pawel Sliwinski, Marcel Mallet, Anne-Marie Kirsten, Jutta Beier, Beatriz Seoane, Rosa Maria Segarra, Anne Leselbaum
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...
October 2016: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
Peter Lange, Nina Skavlan Godtfredsen, Beata Olejnicka, Bo-Anders Paradis, Dan Curiac, Sjur Humerfelt, Gunilla Telg, Helene Nordahl Christensen, Magnus Alexander Bitsch, Elisabeth Wreford Andersen, Leif Bjermer
INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a progressive disease with symptoms that can have a major impact on patients' physical health. The aim of this study was to evaluate quality of life (QoL), symptom severity and dyspnoea in COPD patients treated with aclidinium up to 24 weeks. METHODS: In this prospective non-interventional multicentre study (198 centres in Sweden, Denmark, and Norway), COPD patients (age ≥40 years) who started treatment with aclidinium (initial therapy, change of treatment, or add-on therapy) could be included...
2016: European Clinical Respiratory Journal
James F Donohue, Weily Soong, Xiao Wu, Pomy Shrestha, Alejhandra Lei
TRIAL DESIGN: This was a one-year, Phase III randomized, double-blind, parallel-group, active-control study investigating the long-term safety and tolerability of twice-daily aclidinium 400 μg/formoterol 12 μg versus formoterol 12 μg. METHODS: Eligible patients were male or female, current or ex-smokers (history of ≥10 pack-years) aged ≥40 years with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD): post-bronchodilator forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) ratio <70%, and post-bronchodilator FEV1≥30% and <80% predicted...
July 2016: Respiratory Medicine
Hiroaki Kume
Long-acting β2-adrenergic receptor agonists (LABAs) and anticholinergics (LAMAs) are widely used clinically as therpy for COPD. Clinical reports have demonstrated that LABAs (salmeterol, formoterol, indacaterol, olodaterol, vilanterol) and LAMAs (tiotropium, glycopyrronium, umeclidinium, aclidinium) are useful to improving symptoms and lung function, and to reducing exacerbation and hospitarization. LABAs expect salmeterol are strong partial agonists, and LAMAs are non-specific antagonists. Ca2+ dynamics and Ca2+ sensitization contribute to relaxation of airway smooth muscle in these bronchodilators...
May 2016: Nihon Rinsho. Japanese Journal of Clinical Medicine
Paul W Jones, Nancy K Leidy, Asha Hareendran, Rosa Lamarca, Ferran Chuecos, Esther Garcia Gil
BACKGROUND: Reducing the severity of respiratory symptoms is a key goal in the treatment of chronic obstructive pulmonary disease (COPD). We evaluated the effect of aclidinium bromide 400 μg twice daily (BID) on respiratory symptoms, assessed using the Evaluating Respiratory Symptoms in COPD (E-RS(™): COPD) scale (formerly EXACT-RS). METHODS: Data were pooled from the aclidinium 400 μg BID and placebo arms of two 24-week, double-blind, randomized Phase III studies evaluating aclidinium monotherapy (ATTAIN) or combination therapy (AUGMENT COPD I) in patients with moderate to severe airflow obstruction...
May 23, 2016: Respiratory Research
Jadwiga A Wedzicha, Alvar Agusti, Gavin Donaldson, Ferran Chuecos, Rosa Lamarca, Esther Garcia Gil
We investigated the effect of the long-acting muscarinic antagonist aclidinium bromide on chronic obstructive pulmonary disease (COPD) exacerbations by pooling data from five randomized, placebo-controlled, parallel-group Phase III studies of 3-6 months' duration. Data were pooled from the aclidinium 400 μg twice-daily (BID) and placebo arms (N  =  2,521) and stratified by Global initiative for chronic Obstructive Lung Disease (GOLD) group (A, B, C and D). Results showed that fewer patients experienced ≥1 exacerbation with aclidinium (any severity: 12...
December 2016: COPD
Joshua S Cohen, Matthew C Miles, James F Donohue, Jill A Ohar
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity, mortality, and health care expenditure worldwide. Relaxation of airway smooth muscle with inhaled bronchodilators is the cornerstone of treatment for stable COPD, with inhaled corticosteroids reserved for those with a history of exacerbations. Tiotropium has occupied center stage in COPD treatment for over 10 years and improves lung function, quality of life, exercise endurance, and reduces the risk of COPD exacerbation. Long-acting β2-agonists (LABAs) improve lung function, reduce dynamic hyperinflation, increase exercise tolerance, health-related quality of life, and reduce acute exacerbation of COPD...
2016: International Journal of Chronic Obstructive Pulmonary Disease
Rainard Fuhr, Anne Leselbaum, Jordi Aubets
Inhaled, long-acting bronchodilators represent a cornerstone of maintenance treatment for chronic obstructive pulmonary disease (COPD). Aclidinium bromide/formoterol fumarate 400/12 μg fixed-dose combination (FDC) has recently been licensed for use in adults with COPD in the European Union. This phase 1, randomized, open-label, 3-way, complete crossover, single-dose study assessed the pharmacokinetics, safety, and tolerability of an FDC, aclidinium bromide 400 μg, and formoterol fumarate 12 μg, all administered via Genuair™ to 30 healthy subjects...
March 2016: Clinical Pharmacology in Drug Development
Donatella Mutolo, Elenia Cinelli, Ludovica Iovino, Tito Pantaleo, Fulvia Bongianni
Long-acting muscarinic receptor antagonists (LAMAs) have been reported to attenuate cough in preclinical and clinical studies. The present study was performed on rabbits to compare aclidinium and tiotropium efficacy in the downregulation of the cough reflex. This reflex was evoked by citric acid inhalation in unanesthetized animals and by both citric acid inhalation and mechanical stimulation of the tracheobronchial tree in anesthetized animals 90 min following the inhalation of each drug (nebulizer output always at 1 mL/min)...
April 11, 2016: Pulmonary Pharmacology & Therapeutics
Maria Gabriella Matera, Alessandro Sanduzzi, Roberto Alfano, Mario Cazzola
Aclidinium is a twice-daily long-acting muscarinic receptor antagonist (LAMA) with an interesting pharmacological profile. Recent evidence indicates that this LAMA, in addition to causing a significant improvement in lung function and other important supportive outcomes, such as health related quality of life, dyspnea and nighttime/early morning symptoms in patients suffering from COPD, is also able to significantly reduce the rate of exacerbations of any severity, is extremely effective in controlling the COPD symptoms, is able to reduce lung hyperinflation, and has an excellent cardiovascular safety profile...
June 2016: Expert Review of Clinical Pharmacology
Cristoforo Incorvaia, Marcello Montagni, Elena Makri, Erminia Ridolo
The current guidelines on chronic obstructive pulmonary disease (COPD) recommend the prominent use of bronchodilators, including long-acting β2-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs), while inhaled corticosteroids are recommended only in patients with severe disease or frequent exacerbations. LABA-LAMA combinations are indicated when single bronchodilators are insufficient to control COPD. A number of LABA-LAMA combinations are available, based on twice-daily or once-daily administration according to the 12- or 24-hour duration of action, respectively...
2016: Therapeutics and Clinical Risk Management
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