- A phase III study of triple therapy with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler 320/18/9.6 μg and 160/18/9.6 μg using co-suspension delivery technology in moderate-to-very severe COPD: The ETHOS study protocol. [Journal Article]Respir Med 2019; 158:59-66RM
- CONCLUSIONS: ETHOS will provide data on exacerbations, patient-reported outcomes, mortality, and safety in 8572 patients with moderate-to-very severe COPD receiving triple and dual fixed-dose combinations. For the first time, ICS/LAMA/LABA triple therapy with two different doses of ICS will be compared to dual ICS/LABA and LAMA/LABA therapies.
- Single inhaler extrafine triple therapy in uncontrolled asthma (TRIMARAN and TRIGGER): two double-blind, parallel-group, randomised, controlled phase 3 trials. [Journal Article]Lancet 2019Lct
- CONCLUSIONS: In uncontrolled asthma, addition of a long-acting muscarinic antagonist to inhaled corticosteroid plus long-acting β2-agonist therapy improves lung function and reduces exacerbations.
- Vibrating Mesh Nebulizers for Patients with Respiratory Conditions: Clinical Effectiveness, Cost-Effectiveness, and Guidelines [BOOK]Canadian Agency for Drugs and Technologies in Health: Ottawa (ON)BOOK
- Patients with a variety of respiratory conditions in acute care settings may require aerosolized medications. These respiratory conditions include chronic obstructive pulmonary disease (COPD), asthma, bronchitis, bacterial pneumonia, bronchiectasis, and emphysema.1,2 Medications used to treat these conditions include various antibiotics1 and bronchodilators, such as tiotropium bromide,2 arformote…
Patients with a variety of respiratory conditions in acute care settings may require aerosolized medications. These respiratory conditions include chronic obstructive pulmonary disease (COPD), asthma, bronchitis, bacterial pneumonia, bronchiectasis, and emphysema.1,2 Medications used to treat these conditions include various antibiotics1 and bronchodilators, such as tiotropium bromide,2 arformoterol tartrate,2 formoterol fumarate,2 albuterol sulfate,2 ipratropium bromide,2 albuterol-ipratropium,2 acetylcysteine,3 racemic epinephrine,3 and levalbuterol3 and corticosteroids such as budesonide.3 Patients with respiratory conditions in acute care settings may have particular requirements such as need for invasive mechanical ventilation; the aerosolized medication devices may therefore have unique clinical effectiveness profiles in this population. Devices used to generate therapeutic aerosols for these patients include metered-dose inhalers (MDIs), slow mist inhalers, dry powder inhalers, jet nebulizers (JNs), ultrasonic nebulizers, and vibrating mesh nebulizers (VMNs), and there are strengths and limitations of each.2 JNs are the most commonly used nebulizers, and have remained a relatively consistent standard for over 20 years, but JNs require a compressed gas source whereas MDIs and VMNs do not.1 MDIs require less labour and are less likely to be a source of contamination, however they often require patient coordination and appropriate doses may be more difficult to deliver.2,4 In contrast, VMNs have been associated with increased labour requirements as compared to JN,4,5 require cleaning after every dose,2,4 and have a high upfront investment cost.4 VMNs however do not require patient coordination, can deliver high doses faster than JN, are quieter,2,4 lighter and portable,1,2 and have been associated with lower undelivered drug volumes.1,6 The purpose of this report is to retrieve and appraise the evidence for the clinical effectiveness, safety, and cost-effectiveness of VMN as compared to JN and MDI for patients with respiratory conditions in acute care settings. Additionally, this report aims to retrieve and review current evidence-based guidelines regarding effective use of VMN in acute care settings.
- Inhaled steroids with and without regular formoterol for asthma: serious adverse events. [Journal Article]Cochrane Database Syst Rev 2019; 9:CD006924CD
- CONCLUSIONS: We did not find a difference in the risk of death (all-cause or asthma-related) in adults taking combined formoterol and ICS versus ICS alone (moderate- to low-certainty evidence). No deaths were reported in children and adolescents. The risk of dying when taking either treatment was very low, but we cannot be certain if there is a difference in mortality when taking additional formoterol to ICS (low-certainty evidence).We did not find a difference in the risk of non-fatal SAEs of any cause in adults (high-certainty evidence). A previous version of the review had shown a lower risk of asthma-related SAEs in adults taking combined formoterol and ICS; however, inclusion of new studies no longer shows a difference between treatments (moderate-certainty evidence).The reported number of children and adolescents with SAEs was small, so uncertainty remains in this age group.We included results from large studies mandated by the FDA. Clinical decisions and information provided to patients regarding regular use of formoterol and ICS need to take into account the balance between known symptomatic benefits of formoterol and ICS versus the remaining degree of uncertainty associated with its potential harmful effects.
- Exacerbations, Health Resource Utilization, and Costs Among Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease Treated with Nebulized Arformoterol Following a Respiratory Event. [Journal Article]Chronic Obstr Pulm Dis 2019; 6(4)CO
- CONCLUSIONS: Switching from handheld ICS+LABA to nebulized ARF resulted in fewer COPD exacerbations among Medicare beneficiaries. Nebulized LABAs may improve outcomes in selected patients with COPD.
- Glycopyrronium/Formoterol: A Review in COPD. [Review]Drugs 2019; 79(13):1455-1466D
- Glycopyrronium/formoterol (Bevespi Aerosphere®) is a fixed-dose combination of the long-acting muscarinic antagonist glycopyrronium bromide and the long-acting β2-agonist formoterol fumarate delivered via a pressurized metered dose inhaler (pMDI) and formulated using co-suspension delivery technology. It is approved in the USA and EU for use as maintenance treatment in patients with chronic obstr…
Glycopyrronium/formoterol (Bevespi Aerosphere®) is a fixed-dose combination of the long-acting muscarinic antagonist glycopyrronium bromide and the long-acting β2-agonist formoterol fumarate delivered via a pressurized metered dose inhaler (pMDI) and formulated using co-suspension delivery technology. It is approved in the USA and EU for use as maintenance treatment in patients with chronic obstructive pulmonary disease (COPD) and in Japan to relieve symptoms in patients with COPD. In the PINNACLE trials in patients with moderate to very severe COPD, glycopyrronium/formoterol was associated with significantly greater improvements in lung function than its monocomponents and placebo at 24 weeks and its monocomponents and open-label tiotropium over 52 weeks. In the AERISTO trial, glycopyrronium/formoterol was non-inferior to umeclidinium/vilanterol dry powder inhaler for peak change in forced expiratory volume in 1 s (FEV1) within 2 h postdose, but not for the change in morning predose trough FEV1, over 24 weeks. Glycopyrronium/formoterol was generally well tolerated in patients with moderate to very severe COPD, with most adverse events (AEs) being of mild or moderate severity. Thus, glycopyrronium/formoterol pMDI formulated using co-suspension delivery technology is a useful new addition that extends treatment options for patients with COPD.
- As-needed β agonist-inhaled corticosteroid in mild asthma. [Comment]Lancet 2019; 394(10202):897-898Lct
- Multiple analytical methods for determination of formoterol and glycopyrronium simultaneously in their novel combined metered dose inhaler. [Journal Article]BMC Chem 2019; 13(1):75BC
- One of the major causes of mortality all over the world is chronic obstructive pulmonary disease (COPD). Recently approved combined inhaler of formoterol fumarate (FF) and glycopyrronium bromide (GLY) has been used in very low concentrations (µg level/actuation) doses in COPD patients. The first spectrophotometric and advanced highly sensitive liquid chromatography has been achieved successfully …
One of the major causes of mortality all over the world is chronic obstructive pulmonary disease (COPD). Recently approved combined inhaler of formoterol fumarate (FF) and glycopyrronium bromide (GLY) has been used in very low concentrations (µg level/actuation) doses in COPD patients. The first spectrophotometric and advanced highly sensitive liquid chromatography has been achieved successfully throughout this study, permitting validated analysis of dual combined inhaler in raw material as well as pharmaceutical inhaled dosage form. Three sensitive analytical methods were carried out for the simultaneous assay of FF and GLY in their novel combined Metered dose inhaler (MDI). The first method depends on measuring the first derivative amplitudes at 208.27 nm for FF and at 213.27 nm and 239.86 nm for GLY, respectively. The second method depends on measurement of the first derivative of the ratio spectra at 214 or 229 nm for FF and 240 or 259 nm for GLY, respectively. For the spectrophotometric methods, the linearity ranges were 0.48-9.6 µg/mL for FF and 0.9-18 µg/mL for GLY. For the third method, valid ion-pairing chromatographic method was carried out applying C18 column and isocratic mobile phase of 60% v/v acetonitrile and 40% v/v deionized waster (pH 3.0) enclosing 0.025% sodium dodecyl sulfate, using UV detection adjusted to 210 nm and flow rate of 1.2 mL/min. For the ion-pairing chromatographic method, the linearity ranges were 0.048-4.8 µg/mL for FF and 0.09-9.0 µg/mL for GLY. The developed methods are reproducible, valid and offer efficient resolution between formoterol and glycopyrronium using spectrophotometric methods and highly sensitive and precise chromatographic method. The percent recoveries of the inhaled drugs in their MDI were good. The method was successfully established for the quantitative analysis of FF and GLY in their combined pharmaceutical inhaler capsules to validate the therapeutic efficiency of the combined drugs in quality control labs.
- Bone and ocular safety of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in COPD: a 52-week randomized study. [Journal Article]Respir Res 2019; 20(1):167RR
- CONCLUSIONS: In patients with COPD, both ICS-containing therapies were non-inferior to GFF MDI for the primary BMD and ophthalmological endpoints. Changes from baseline in all three treatment groups over 52 weeks were small and not clinically meaningful. All treatments were well tolerated with no new or unexpected safety findings.
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- A Randomized, Double-Blind, Double-Dummy Study of Glycopyrrolate/Formoterol Fumarate Metered Dose Inhaler Relative to Umeclidinium/Vilanterol Dry Powder Inhaler in COPD. [Journal Article]Adv Ther 2019; 36(9):2434-2449AT
- CONCLUSIONS: Over 24 weeks of treatment, GFF MDI was non-inferior to UV DPI for peak FEV1, but not for morning pre-dose trough FEV1. GFF MDI had a faster onset of action versus UV DPI. There were no clinically meaningful differences between treatments in symptom endpoints. Both treatments were well tolerated with similar safety profiles.