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LABA safety

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https://www.readbyqxmd.com/read/28008228/spotlight-on-fluticasone-furoate-vilanterol-trifenatate-for-the-once-daily-treatment-of-asthma-design-development-and-place-in-therapy
#1
REVIEW
Timothy E Albertson, Samuel W Bullick, Michael Schivo, Mark E Sutter
The use of inhaled corticosteroids (ICSs) plays a key role in the treatment of asthmatic patients, and international guidelines have designated ICSs as an early maintenance therapy in controlling asthma symptoms. When asthmatic patients remain symptomatic on ICSs, one common option is to add a long-acting beta2 agonist (LABA) to the maintenance treatment. Fixed combination inhalers that contain both an ICS and a LABA have been popular for both chronic obstructive pulmonary disease (COPD) and asthma. Historically, these inhalers have been dosed twice daily...
2016: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/27965773/treatment-of-asthma-in-young-children-evidence-based-recommendations
#2
REVIEW
Jose A Castro-Rodriguez, Adnan Custovic, Francine M Ducharme
: In the present review, we focus on evidence-based data for the use of inhaled corticosteroids (ICS), leukotriene receptor antagonist (LTRA), long-acting beta2-agonits (LABA) and oral corticosteroids (OCS), with a special emphasis on well-performed randomized clinical trials (RCTs) and meta-analyses of such trials for the chronic management of asthma/wheeze in infants and preschoolers. RESULTS: Seven meta-analyses and 14 RCTs were reviewed. Daily ICS should be the preferred drug for infants/preschoolers with recurrent wheezing, especially in asthmatics...
2016: Asthma research and practice
https://www.readbyqxmd.com/read/27957746/the-impact-of-olodaterol-on-the-risk-of-mortality-and-serious-adverse-events-a-systematic-review-and-meta-analysis
#3
Hyun Woo Lee, Hyung-Jun Kim, Chang-Hoon Lee
AIMS: Olodaterol is a novel inhaled long-acting beta-agonist (LABA) that showed efficacy as a bronchodilator for patients with chronic obstructive pulmonary disease (COPD) and asthma. However, it is unclear whether olodaterol reduces mortality; the safety issues of olodaterol have not been fully evaluated. METHODS: Randomized controlled trials comparing olodaterol with placebo for patients with COPD or asthma, which evaluated mortality or serious adverse events, were included...
December 13, 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27938358/high-strength-extrafine-pmdi-beclometasone-formoterol-200-6%C3%A2-%C3%AE-g-is-effective-in-asthma-patients-not-adequately-controlled-on-medium-high-dose-of-inhaled-corticosteroids
#4
Pierluigi Paggiaro, Massimo Corradi, Manuela Latorre, Helene Raptis, Annamaria Muraro, Christian Gessner, Zenon Siergiejko, Mario Scuri, Stefano Petruzzelli
BACKGROUND: A high strength of beclomethasone/formoterol fumarate (BDP/FF) in a pressurised metered dose inhaler (pMDI), which contains extrafine BDP (200 μg/actuation) and FF (6 μg/actuation) has been developed to treat those asthmatics who are not adequately controlled on previous treatments. METHODS: A 12-week, randomized, double-blind, parallel group study was performed to compare the efficacy and safety of pMDI BDP/FF 200/6 (two actuations bid) with BDP 100 μg (four actuation bid) in a population of 376 randomized adult asthmatics not adequately controlled with high dose of inhaled corticosteroids (ICS) or medium dose of ICS plus long acting β2agonists (LABA)...
December 9, 2016: BMC Pulmonary Medicine
https://www.readbyqxmd.com/read/27932872/randomized-controlled-trials-and-real-world-observational-studies-in-evaluating-cardiovascular-safety-of-inhaled-bronchodilator-therapy-in-copd
#5
Peter Kardos, Sally Worsley, Dave Singh, Miguel Román-Rodríguez, David E Newby, Hana Müllerová
Long-acting muscarinic antagonist (LAMA) or long-acting β2-agonist (LABA) bronchodilators and their combination are recommended for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Although the efficacy of LAMAs and LABAs has been well established through randomized controlled trials (RCTs), questions remain regarding their cardiovascular (CV) safety. Furthermore, while the safety of LAMA and LABA monotherapy has been extensively studied, data are lacking for LAMA/LABA combination therapy, and the majority of the studies that have reported on the CV safety of LAMA/LABA combination therapy were not specifically designed to assess this...
2016: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/27931291/effects-of-the-addition-of-tiotropium-on-airway-dimensions-in-symptomatic-asthma
#6
Makoto Hoshino, Junichi Ohtawa, Kenta Akitsu
BACKGROUND: Tiotropium, a once-daily, long-acting anticholinergic bronchodilator, has shown efficacy and safety as an add-on to maintenance therapy in patients with symptomatic asthma. OBJECTIVE: The aim of the present study was to assess the effect of tiotropium on airway geometry and airway inflammation in patients with asthma who were symptomatic despite treatment with inhaled corticosteroid (ICS) plus a long-acting beta 2agonist (LABA). METHODS: In total, 53 patients with symptomatic asthma who received ICS plus LABA and who had a prebronchodilator forced expiratory volume in 1 second of 6090% of the predicted value were randomized to the addition of tiotropium 5 g once daily (n = 25) or no add-on (n = 28) to maintenance therapy for 48 weeks...
November 2016: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/27916620/efficacy-and-safety-of-glycopyrrolate-formoterol-mdi-formulated-using-co-suspension%C3%A2-delivery-technology-in-patients-with-copd
#7
Fernando J Martinez, Klaus F Rabe, Gary T Ferguson, Leonardo M Fabbri, Stephen Rennard, Gregory J Feldman, Sanjay Sethi, Selwyn Spangenthal, Gregory M Gottschlich, Roberto Rodriguez-Roisin, Samir Arora, Thomas M Siler, Shahid Siddiqui, Patrick Darken, Tracy Fischer, Andrea Maes, Michael Golden, Chad Orevillo, Colin Reisner
BACKGROUND: Long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) combinations are a treatment option for patients with chronic obstructive pulmonary disease (COPD) who continue to have symptoms despite treatment with a LAMA or LABA alone. OBJECTIVES: The PINNACLE-1 (NCT01854645) and -2 (NCT01854658) trials investigated the efficacy and safety of a novel GFF MDI (glycopyrrolate [GP]/formoterol [FF] 18/9.6 μg metered dose inhaler [MDI]) formulated using Co-Suspension™ Delivery Technology, in patients with moderate-to-very severe COPD...
December 1, 2016: Chest
https://www.readbyqxmd.com/read/27826703/leukotriene-receptor-antagonists-and-antiallergy-drugs
#8
Tsutomu Tamada, Masakazu Ichinose
As one of the candidates of the therapeutic strategy for asthma in addition to inhaled corticosteroids (ICS), leukotriene receptor antagonists (LTRAs) are known to be useful for long-term management of asthma patients complicated by allergic rhinitis (AR) or exercise-induced asthma (EIA). Currently available LTRAs are pranlukast hydrate, zafirlukast, and montelukast. These LTRAs have a bronchodilator action and inhibit airway inflammation, resulting in a significant improvement of asthma symptoms, respiratory function, inhalation frequency of as-needed inhaled β2-agonist, airway inflammation, airway hyperresponsiveness, dosage of ICSs, asthma exacerbations, and patients' QOL...
November 9, 2016: Handbook of Experimental Pharmacology
https://www.readbyqxmd.com/read/27817819/efficacy-and-safety-comparison-fluticasone-furoate-and-fluticasone-propionate-after-step-down-from-fluticasone-furoate-vilanterol-in-japanese-patients-with-well-controlled-asthma-a-randomized-trial
#9
Mitsuru Adachi, Caroline Goldfrad, Loretta Jacques, Yoshie Nishimura
BACKGROUND: For patients with well-controlled asthma, 'step down' of therapy is recommended. We evaluated Japanese patients switching from inhaled corticosteroid (ICS)/long-acting beta2-agonists (LABA; equivalent to fluticasone propionate [FP]/salmeterol [SAL] 250/50 μg twice daily [BD]) to fluticasone furoate (FF)/vilanterol (VI) 100/25 μg, then stepping down to ICS alone. METHODS: This phase III trial had two treatment periods (P): P1, patients with well-controlled asthma on FP/SAL 250/50 μg BD equivalent stepped across to once daily (OD) FF/VI 100/25 μg (open-label, eight weeks); P2, patients remaining 'well controlled' after P1 stepped down to FF 100 μg OD/FP 100 μg BD/FP 250 μg BD (randomized 1:1:1, double-blind, 12 weeks)...
November 2016: Respiratory Medicine
https://www.readbyqxmd.com/read/27789954/use-of-ics-laba-extra-fine-and-non-extra-fine-in-elderly-asthmatics
#10
REVIEW
Alida Benfante, Marco Basile, Salvatore Battaglia, Mario Spatafora, Nicola Scichilone
Age represents an exclusion criterion in randomized clinical trials designed to test the efficacy and safety of inhaled drugs in asthma. As a consequence, data on efficacy and safety of inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) combinations in elderly asthmatics are scanty. Older age is associated with an increased proportion of comorbid conditions; in addition, all organ functions undergo a process of senescence, thus reducing their ability to metabolize the agents. Overall, these age-associated conditions may variably, and often unpredictably, affect the metabolism and excretion of respiratory drugs...
2016: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/27787709/muscarinic-receptor-antagonists
#11
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
https://www.readbyqxmd.com/read/27759640/combined-inhaled-corticosteroid-and-long-acting-%C3%AE-2-adrenergic-agonist-therapy-for-noncystic-fibrosis-bronchiectasis-with-airflow-limitation-an-observational-study
#12
Ping Wei, Jia-Wei Yang, Hai-Wen Lu, Bei Mao, Wen-Lan Yang, Jin-Fu Xu
BACKGROUND AND OBJECTIVE: There is presently no clear evidence on the effect of combined treatment for non-cystic fibrosis (non-CF) bronchiectasis with inhaled corticosteroid (ICS) and long-acting β2-adrenergic agonist (LABA). The objective of this study is to assess the efficacy and safety of salmeterol-fluticasone combined inhaled therapy for non-CF bronchiectasis with airflow limitation. METHODS: An observational study was performed in 120 non-CF bronchiectasis patients diagnosed by high-resolution computed tomography (HRCT) scanning of the chest...
October 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27735927/inappropriate-asthma-therapy-a-tale-of-two-countries-a-parallel-population-based-cohort-study
#13
Manon Belhassen, Anjan Nibber, Eric Van Ganse, Dermot Ryan, Carole Langlois, Francis Appiagyei, Derek Skinner, Laurent Laforest, Joan B Soriano, David Price
Against recurrent controversies around the safety of short- and long-acting β2-agonists (SABA and LABA), and the National Review of Asthma Deaths inquiry in the United Kingdom, we investigated the prevalence of inappropriate therapy in asthma. Our study aimed to determine the prevalence of inappropriate use of asthma therapy in the United Kingdom and in France. Two interval, parallel, population-based cohorts (2007 and 2013) were developed in each country by using the UK OPCRD and the French EGB databases...
October 13, 2016: NPJ Primary Care Respiratory Medicine
https://www.readbyqxmd.com/read/27730192/cardiac-impact-of-inhaled-therapy-in-the-largest-randomised-placebo-controlled-trial-in-copd-history-have-we-reached-the-summit
#14
Stefan Andreas, Christer Janson, Maarten van den Berge, Lies Lahousse
SUMMIT supports the efficiency and cardiovascular safety of LABA and ICS in COPD patients at cardiovascular risk http://ow.ly/p6Is300ffoc.
April 2016: ERJ Open Research
https://www.readbyqxmd.com/read/27715335/efficacy-and-safety-of-indacaterol-glycopyrronium-ind-gly-versus-salmeterol-fluticasone-in-chinese-patients-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-the-chinese-cohort-from-the-lantern-study
#15
Nanshan Zhong, Changzheng Wang, Xiangdong Zhou, Nuofu Zhang, Michael Humphries, Linda Wang, Francesco Patalano, Donald Banerji
Inhaled indacaterol/glycopyrronium fixed-dose combination (IND/GLY) is approved in over 80 countries, including the EU, Japan, Australia and Switzerland and the US. The LANTERN study evaluated the efficacy of IND/GLY compared with inhaled long-acting β2-agonist (LABA)/inhaled corticosteroid (ICS) or salmeterol/fluticasone (SFC) in patients with moderate-to-severe COPD with a history of ≤1 exacerbation in the previous year. Here we present the efficacy and safety of IND/GLY versus SFC in the Chinese cohort from the LANTERN study...
December 2016: COPD
https://www.readbyqxmd.com/read/27679681/tiotropium-in-asthma-what-is-the-evidence-and-how-does-it-fit-in
#16
REVIEW
David M G Halpin
Despite current therapeutic approaches asthma remains uncontrolled in a significant proportion of patients. Short-acting anticholinergic bronchodilators have a very long history of use in asthma, and recent data confirms the importance of acetylcholine as both a bronchoconstrictor and as a regulator of inflammation and remodeling in the lungs. Data from a comprehensive clinical trial programme, as well as use in primary care, show the efficacy and safety of tiotropium in adults with mild to moderate asthma when it is added to ICS and in severe asthma when it is added to high doses of ICS plus LABA, as well as in adolescents...
2016: World Allergy Organization Journal
https://www.readbyqxmd.com/read/27612491/tiotropium-in-the-add-on-treatment-of-asthma-in-adults-clinical-trial-evidence-and-experience
#17
REVIEW
Christian Vogelberg
Asthma is a chronic inflammatory airway disease, and its treatment is frequently challenging despite detailed national and international guidelines. While basic anti-inflammatory therapy usually consists of inhaled corticosteroids in doses adapted to the asthma severity, add-on treatment with bronchodilators is essential in more severe asthma. Only recently, the long-acting anticholinergic tiotropium was introduced into the GINA guidelines. This review reports on the studies that have been performed with tiotropium in adult asthmatic patients...
December 2016: Therapeutic Advances in Respiratory Disease
https://www.readbyqxmd.com/read/27609408/efficacy-and-safety-of-benralizumab-for-patients-with-severe-asthma-uncontrolled-with-high-dosage-inhaled-corticosteroids-and-long-acting-%C3%AE-2-agonists-sirocco-a-randomised-multicentre-placebo-controlled-phase-3-trial
#18
Eugene R Bleecker, J Mark FitzGerald, Pascal Chanez, Alberto Papi, Steven F Weinstein, Peter Barker, Stephanie Sproule, Geoffrey Gilmartin, Magnus Aurivillius, Viktoria Werkström, Mitchell Goldman
BACKGROUND: Eosinophilia is associated with worsening asthma severity and decreased lung function, with increased exacerbation frequency. We assessed the safety and efficacy of benralizumab, a monoclonal antibody against interleukin-5 receptor α that depletes eosinophils by antibody-dependent cell-mediated cytotoxicity, for patients with severe, uncontrolled asthma with eosinophilia. METHODS: We did a randomised, double-blind, parallel-group, placebo-controlled phase 3 study at 374 sites in 17 countries...
October 29, 2016: Lancet
https://www.readbyqxmd.com/read/27609406/benralizumab-an-anti-interleukin-5-receptor-%C3%AE-monoclonal-antibody-as-add-on-treatment-for-patients-with-severe-uncontrolled-eosinophilic-asthma-calima-a-randomised-double-blind-placebo-controlled-phase-3-trial
#19
J Mark FitzGerald, Eugene R Bleecker, Parameswaran Nair, Stephanie Korn, Ken Ohta, Marek Lommatzsch, Gary T Ferguson, William W Busse, Peter Barker, Stephanie Sproule, Geoffrey Gilmartin, Viktoria Werkström, Magnus Aurivillius, Mitchell Goldman
BACKGROUND: Benralizumab is a humanised, afucosylated, anti-interleukin-5 receptor α monoclonal antibody that induces direct, rapid, and nearly complete depletion of eosinophils. We aimed to assess the efficacy and safety of benralizumab as add-on therapy for patients with severe, uncontrolled asthma and elevated blood eosinophil counts. METHODS: In this randomised, double-blind, parallel-group, placebo-controlled, phase 3 study (CALIMA) undertaken at 303 sites in 11 countries, we enrolled patients aged 12-75 years with severe asthma uncontrolled by medium-dosage to high-dosage inhaled corticosteroids plus long-acting β₂-agonists (ICS plus LABA) and a history of two or more exacerbations in the previous year...
October 29, 2016: Lancet
https://www.readbyqxmd.com/read/27585384/effect-of-roflumilast-and-inhaled-corticosteroid-long-acting-%C3%AE-2-agonist-on-chronic-obstructive-pulmonary-disease-exacerbations-re-2-spond-a-randomized-clinical-trial
#20
Fernando J Martinez, Klaus F Rabe, Sanjay Sethi, Emilio Pizzichini, Andrew McIvor, Antonio Anzueto, Vijay K T Alagappan, Shahid Siddiqui, Ludmyla Rekeda, Christopher J Miller, Sofia Zetterstrand, Colin Reisner, Stephen I Rennard
RATIONALE: Moderate and severe exacerbations are incompletely prevented by maximal inhalation therapy in patients with severe chronic obstructive pulmonary disease. OBJECTIVES: To determine whether roflumilast reduces moderate and/or severe chronic obstructive pulmonary disease exacerbations in patients at risk for exacerbations despite treatment with inhaled corticosteroid/long-acting β2-agonist with or without a long-acting muscarinic antagonist (LAMA). METHODS: In this 52-week, phase 4, double-blind, placebo-controlled RE(2)SPOND (Roflumilast Effect on Exacerbations in Patients on Dual [LABA/ICS] Therapy) trial (NCT01443845), participants aged 40 years or older with severe/very severe chronic obstructive pulmonary disease, chronic bronchitis, two or more exacerbations and/or hospitalizations in the previous year, and receiving inhaled corticosteroid/long-acting β2-agonist with or without LAMA daily for 3 or more months were equally randomized to once-daily roflumilast, 500 μg (n = 1,178), or placebo (n = 1,176)...
September 1, 2016: American Journal of Respiratory and Critical Care Medicine
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