Read by QxMD icon Read


Edward M Kerwin, Selwyn Spangenthal, Christine Kollar, Earl St Rose, Colin Reisner
BACKGROUND: Long-acting muscarinic antagonist (LAMA) and long-acting β2 -agonist (LABA) bronchodilators are key to the pharmacologic treatment of chronic obstructive pulmonary disease (COPD). This Phase IIb study investigated the safety and efficacy of four doses of the LAMA glycopyrronium (GP) delivered using co-suspension delivery technology via metered dose inhaler (MDI). The study was part of a wider clinical trial program performed to determine the optimal dose of GP MDI, the LABA formoterol fumarate dihydrate (FF) MDI, and glycopyrronium/formoterol fumarate dihydrate (GFF) MDI fixed-dose combination to be taken forward into Phase III studies...
March 5, 2018: Respiratory Research
Jens M Hohlfeld, Jens Vogel-Claussen, Heike Biller, Dominik Berliner, Korbinian Berschneider, Hanns-Christian Tillmann, Simone Hiltl, Johann Bauersachs, Tobias Welte
BACKGROUND: Pulmonary hyperinflation in chronic obstructive pulmonary disease (COPD) is associated with reduced biventricular end-diastolic volumes and increased morbidity and mortality. The combination of a long-acting β agonist (LABA) and a muscarinic antagonist (LAMA) is more effective in reducing hyperinflation than LABA-inhaled corticosteroid combination therapy but whether dual bronchodilation improves cardiac function is unknown. METHODS: We did a double-blind, randomised, two-period crossover, placebo-controlled, single-centre study (CLAIM) at the Fraunhofer Institute of Toxicology and Experimental Medicine (Hannover, Germany), a specialty clinic...
February 21, 2018: Lancet Respiratory Medicine
Alberto Papi, Jørgen Vestbo, Leonardo Fabbri, Massimo Corradi, Hélène Prunier, Géraldine Cohuet, Alessandro Guasconi, Isabella Montagna, Stefano Vezzoli, Stefano Petruzzelli, Mario Scuri, Nicolas Roche, Dave Singh
BACKGROUND: Evidence is scarce on the relative risk-benefit of inhaled triple therapy, consisting of inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting β2 -agonist, versus dual bronchodilation for chronic obstructive pulmonary disease (COPD). We aimed to compare a single-inhaler triple combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G) versus a single-inhaler dual bronchodilator combination of indacaterol plus glycopyrronium (IND/GLY) in terms of the rate of moderate-to-severe COPD exacerbations over 52 weeks of treatment...
February 8, 2018: Lancet
Emmanuel Naline, Stanislas Grassin Delyle, Hélène Salvator, Marion Brollo, Christophe Faisy, Tatiana Victoni, Charlotte Abrial, Philippe Devillier
BACKGROUND AND PURPOSE: Long-acting muscarinic antagonists (LAMAs) have been recommended for the treatment of chronic obstructive pulmonary disease and (more recently) asthma. However, the in vitro pharmacological profiles of the four LAMAs currently marketed (tiotropium, umeclidinium, aclidinium and glycopyrronium) have not yet been compared (relative to ipratropium) by using the same experimental approach. EXPERIMENTAL APPROACH: With a total of 560 human bronchial rings, we investigated the antagonists' potency, onset and duration of action for inhibition of the contractile response evoked by electrical field stimulation...
January 11, 2018: Pulmonary Pharmacology & Therapeutics
Peter Kardos, Ina Hagedorn-Peinz
Background: The objective of the FAVOR study was to evaluate the effect of indacaterol/glycopyrronium (IND/GLY) versus tiotropium on peak forced expiratory volume in 1 s (FEV1) and also to investigate patient satisfaction and treatment preference. Methods: Patients with moderate-to-severe airflow limitation (FEV1/forced vital capacity ratio of <0.70), those with a COPD assessment test score of ≥10, and those who were maintained on tiotropium HandiHaler® therapy prior to enrollment were recruited for the study, and randomized (1:1) to receive either 4 weeks open-label IND/GLY (110/50 μg) once daily followed by 4 weeks of tiotropium (18 μg) once daily or vice versa...
2018: International Journal of Chronic Obstructive Pulmonary Disease
Yi-Han Hsiao, Ching-Min Tseng, Kang-Cheng Su, Wen-Chian Chen, Mo-Tzu Wu, Yu-Chung Wu, Shi-Chuan Chang, Yu-Chin Lee, Yu Ru Kou, Diahn-Warng Perng
The effects of long-acting muscarinic receptor antagonists (LAMAs) have not been evaluated in a model with simultaneous lung inflammation and small airway remodeling induced by cigarette smoke (CS). We exposed the mice to CS for four weeks with daily treatment with a LAMA (glycopyrronium bromide, NVA237) or its vehicle. Human bronchial epithelial cells (PBECs) and lung fibroblasts were exposed to CS extract (CSE) or acetylcholine with or without NVA237 treatment. We found that NVA237, but not its vehicle, suppressed elevations in inflammatory score, epithelial thickness, and peribronchial collagen deposition in CS-exposed mice...
December 28, 2017: Respiratory Physiology & Neurobiology
(no author information available yet)
The European Medicines Agency (EMA) has granted marketing authorisation for a pressurised metered dose inhaler (pMDI) containing beclometasone dipropionate, formoterol fumarate dihydrate and glycopyrronium bromide (Trimbow - Chiesi Pharmaceuticals) for the treatment of chronic obstructive pulmonary disease (COPD) in patients not adequately treated with a combination of an inhaled corticosteroid (ICS) and a long-acting beta2 agonist (LABA).1-3 The manufacturer claims that this is a significant treatment advance for COPD patients, and that the use of one inhaler should simplify therapy and, therefore, may improve adherence...
December 2017: Drug and Therapeutics Bulletin
Leif Bjermer, Job F M van Boven, Madlaina Costa-Scharplatz, Dorothy L Keininger, Florian S Gutzwiller, Karin Lisspers, Ronan Mahon, Petter Olsson, Nicolas Roche
BACKGROUND: This study assessed the cost-effectiveness of indacaterol/glycopyrronium (IND/GLY) versus salmeterol/fluticasone (SFC) in chronic obstructive pulmonary disease (COPD) patients with moderate to very severe airflow limitation and ≥1 exacerbation in the preceding year. METHODS: A previously published and validated patient-level simulation model was adapted using clinical data from the FLAME trial and real-world cost data from the ARCTIC study. Costs (total monetary costs comprising drug, maintenance, exacerbation, and pneumonia costs) and health outcomes (life-years (LYs), quality-adjusted life-years (QALYs)) were projected over various time horizons (1, 5, 10 years, and lifetime) from the Swedish payer's perspective and were discounted at 3% annually...
December 11, 2017: Respiratory Research
Jeremy R Parr, Emma Todhunter, Lindsay Pennington, Deborah Stocken, Jill Cadwgan, Anne E O'Hare, Catherine Tuffrey, Jane Williams, Mike Cole, Allan F Colver
OBJECTIVE: Investigate whether hyoscine patch or glycopyrronium liquid is more effective and acceptable to treat drooling in children with neurodisability. DESIGN: Multicentre, single-blind, randomised controlled trial. SETTING: Recruitment through neurodisability teams; treatment by parents. PARTICIPANTS: Ninety children with neurodisability who had never received medication for drooling (55 boys, 35 girls; median age 4 years)...
November 30, 2017: Archives of Disease in Childhood
Tadeusz Płusa, Group Of Physicians From Medical Centers In Poland
Indacaterol, as well glycopyronium has been reimbursed lately in Poland, so patients have a greater access to this treatment in medical practice. Physicians do not realize the potential benefit of once daily ultra-LABA indacaterol and/or modern LAMA with fast-acting glycopyrronium on treatment results. AIM: The aim of the study was to evaluate the impact of routinely administered treatment with either indacaterol (Onbrez) or glycopyrronium (Seebri) or both on patient reported outcomes in form of the health status (CCQ score - clinical COPD questionnaire) and level of dyspnoea (mMRC - modified Medical Research Council) in treatment naive COPD patients after the change of treatment as addon from any other COPD treatment in "real life" settings...
October 23, 2017: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
Donald Banerji, Robert Fogel, Francesco Patalano
Indacaterol/glycopyrronium (IND/GLY) 110/50mcg was the first once-daily, long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combination (FDC) approved in Europe for the treatment of chronic obstructive pulmonary disease (COPD). Development of IND/GLY was driven by the need to improve the standard of care for patients with this disease, in terms of symptom control and exacerbation frequency. IGNITE, an adaptive, comprehensive, and innovative Phase 3 development program, demonstrated the efficacy of IND/GLY in optimising bronchodilation, reducing symptoms, and reducing exacerbations in patients with COPD...
October 24, 2017: Drug Discovery Today
Dave Singh, Massimo Corradi, Monica Spinola, Alberto Papi, Omar S Usmani, Mario Scuri, Stefano Petruzzelli, Jørgen Vestbo
The goals of COPD therapy are to prevent and control symptoms, reduce the frequency and severity of exacerbations, and improve exercise tolerance. The triple combination therapy of inhaled corticosteroids (ICSs), long-acting beta2 agonists (LABAs), and long-acting muscarinic antagonists (LAMAs) has become an option for maintenance treatment of COPD and as a "step-up" therapy from single or double combination treatments. There is evidence that triple combination ICS/LABA/LAMA with different inhalers improves lung function, symptoms, and health status and reduces exacerbations...
2017: International Journal of Chronic Obstructive Pulmonary Disease
Glyn Taylor, Simon Warren, Sarvajna Dwivedi, Mark Sommerville, Lauren Mello, Chad Orevillo, Andrea Maes, Ubaldo J Martin, Omar S Usmani
This gamma scintigraphy imaging study was the first to assess pulmonary and extrathoracic deposition and regional lung deposition patterns of a radiolabelled long-acting muscarinic antagonist/long-acting β2-agonist fixed-dose combination glycopyrronium/formoterol fumarate dihydrate (GFF) 14.4/10μg (equivalent to glycopyrrolate/formoterol fumarate 18/9.6μg), delivered by pressurized metered dose inhaler (pMDI) using novel co-suspension delivery technology. In this Phase I, randomized, single-centre, single-blind, single-dose, two-treatment, crossover, placebo-controlled study (PT003020), 10 healthy male adults received two actuations of GFF pMDI (7...
October 18, 2017: European Journal of Pharmaceutical Sciences
Amber Doty, Jon Schroeder, Kou Vang, Mark Sommerville, Mervin Taylor, Brad Flynn, David Lechuga-Ballesteros, Peter Mack
To ensure consistency of clinical outcomes, orally inhaled therapies must exhibit consistent delivered dose and aerosol properties at the time of manufacturing, throughout storage, and during various patient-use conditions. Achieving consistency across these scenarios has presented a significant challenge, especially for combination products that contain more than one drug. This study characterized the delivered dose and aerosol properties of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI; Bevespi Aerosphere™)...
October 10, 2017: AAPS PharmSciTech
Edward Kerwin, Gary T Ferguson, Shahin Sanjar, Thomas Goodin, Anthony Yadao, Robert Fogel, Samopriyo Maitra, Biswajit Sen, Tim Ayers, Donald Banerji
PURPOSE: To compare the efficacy and safety of two long-acting dual bronchodilator combinations: indacaterol/glycopyrrolate (IND/GLY) versus umeclidinium/vilanterol (UMEC/VI). METHODS: Studies A2349 and A2350 were replicate, randomized, double-blind, double-dummy, active-controlled, cross-over studies in patients with moderate-to-severe COPD. Patients were randomized to sequential 12-week treatments of twice-daily IND/GLY 27.5/15.6 μg and once-daily UMEC/VI 62...
December 2017: Lung
Antonio Molino, Francesca Simioli, Anna Agnese Stanziola, Mauro Mormile, Maria Martino, Maria D'Amato
BACKGROUND: Small airways are considered the major site of airflow limitation in COPD. Impulse oscillometry (IOS) is a forced oscillation technique, which provides passive measurement of lung mechanics. It can differentiate small airway from large airway obstruction and is more sensitive than spirometry for peripheral airway disease. In this study the efficacy of the combination of Indacaterol/Glycopirronium (IND/GLY) versus Tiotropium on airway resistance (R5, R20, R5-20), lung reactance (X) and resonant frequency in moderate to severe COPD patients has been evaluated...
2017: Multidisciplinary Respiratory Medicine
Heinrich Worth, Roland Buhl, Carl-Peter Criée, Peter Kardos, Nadine S Lossi, Claus F Vogelmeier
INTRODUCTION: The 2017 update to the Global Initiative for Obstructive Lung Disease (GOLD) strategy document includes recommendations for treatment intensification or step-down in chronic obstructive pulmonary disease (COPD), although recognises that limited supporting information is available. DACCORD is an ongoing observational, non-interventional study, recruiting patients following COPD maintenance treatment change or initiation, a subset of whom were receiving a long-acting β2-agonist (LABA) plus a long-acting muscarinic antagonist (LAMA) fixed-dose combination (FDC) on entry...
October 2017: Respiratory Medicine
Alfred Adiamah, Sarah Johnson, Adrian Ho, James Orbell
Intestinal pseudo-obstruction mimics bowel obstruction. However, on examination, no mechanical cause is identified. This condition will often resolve when managed conservatively, yet in some cases decompression is required to avoid the serious complications of bowel ischaemia and perforation. This is performed endoscopically, and due to the invasive nature and limited access to this service, an alternative treatment option is deemed appealing. Neostigmine has good efficacy in the decompression of pseudo-obstruction but is hindered by its wide side effect profile...
September 11, 2017: BMJ Case Reports
Mario Cazzola, Paola Rogliani
Indacaterol/glycopyrronium has been the first long-acting β2-agonist (LABA)/long-acting muscarinic antagonist (LAMA) fixed-dose combination to be approved as a maintenance treatment in chronic obstructive pulmonary disease patients. Comparative effectiveness studies indicate that it is constantly superior to a LAMA or a LABA alone or even a LABA/inhaled corticosteroid combination, regardless of the drugs used. However, definitive data documenting the benefit of indacaterol/glycopyrronium fixed-dose combination over these consolidated therapies are still absent in a real-world setting, although the results of pivotal randomized controlled trials show that this is the case...
October 2017: Journal of Comparative Effectiveness Research
Santosh Dhungana, Gerard J Criner
Long-acting bronchodilators are the mainstay of the treatment of COPD. With the advent of several combination inhalers with long-acting antimuscarinic agents (LAMAs) and long-acting beta agonists (LABAs), the choice of therapy in the treatment of COPD has been ever expanding. With the focus of COPD management shifting from FEV1-based treatment escalation to symptoms and risk-based treatment, we are seeing a paradigm shift in COPD treatment with early introduction of LAMA-LABA combination as a single inhaler...
2017: International Journal of Chronic Obstructive Pulmonary Disease
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"