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https://www.readbyqxmd.com/read/28205038/clinical-trial-simulations-and-pharmacometric-analysis-in-pediatrics-application-to-inhaled-loxapine-in-children-and-adolescents
#1
Min Dong, Tsuyoshi Fukuda, Sally Selim, Mark A Smith, Laura Rabinovich-Guilatt, James V Cassella, Alexander A Vinks
BACKGROUND AND OBJECTIVES: Loxapine for inhalation is a drug-device combination product approved in adults for the acute treatment of agitation associated with schizophrenia or bipolar I disorder. The primary objective of this study was to develop a clinical trial protocol to support a phase I pharmacokinetic study in children aged 10 years and older. In addition, this report details the results of the clinical study in relation to the predicted likelihood of achieving the target exposure associated with therapeutic effect in adults...
February 15, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/28203364/tiotropium-formulations-and-safety-a-network-meta-analysis
#2
Mario Cazzola, Luigino Calzetta, Paola Rogliani, Maria Gabriella Matera
Tiotropium is now delivered via two different inhaler devices: the original Handihaler 18 μg once daily, which uses a powder formulation; and the newer Respimat Soft Mist Inhaler (SMI) 5 μg once daily. It has been questioned whether the two devices can be assumed to have the same safety profile, although the TIOSPIR trial showed that tiotropium when administered via Respimat SMI 5 μg is not less safe than Handihaler 18 μg. Therefore, we have carried out a safety evaluation of tiotropium Handihaler 18 µg versus tiotropium Respimat SMI 5 µg and 2...
January 2017: Therapeutic Advances in Drug Safety
https://www.readbyqxmd.com/read/28203110/variability-in-delivered-dose-and-respirable-delivered-dose-from-nebulizers-are-current-regulatory-testing-guidelines-sufficient-to-produce-meaningful-information
#3
Ross Hm Hatley, Sarah M Byrne
BACKGROUND: To improve convenience to patients, there have been advances in the operation of nebulizers, resulting in fast treatment times and less drug lost to the environment. However, limited attention has been paid to the effects of these developments on the delivered dose (DD) and respirable delivered dose (RDD). Published pharmacopoeia and ISO testing guidelines for adult-use testing utilize a single breathing pattern, which may not be sufficient to enable effective comparisons between the devices...
2017: Medical Devices: Evidence and Research
https://www.readbyqxmd.com/read/28202554/inhaler-device-handling-have-we-really-started-to-address-the-problem
#4
EDITORIAL
Sinthia Z Bosnic-Anticevich
No abstract text is available yet for this article.
February 2017: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/28193465/application-of-human-augmentics-a-persuasive-asthma-inhaler
#5
Brent Grossman, Steve Conner, Giselle Mosnaim, Joshua Albers, Jason Leigh, Steve Jones, Robert Kenyon
This article describes a tailored health intervention delivered on a mobile phone platform, integrating low-literacy design strategies and basic principles of behavior change, to promote increased adherence and asthma control among underserved minority adolescents. We based the intervention and design principles on theories of Human Augmentics and the Elaboration Likelihood Model. We tested the efficacy of using electronic monitoring devices that incorporate informative and persuasive elements to improve adherence to a prescribed daily medication regimen intended to reduce use of asthma rescue medications...
February 10, 2017: Journal of Biomedical Informatics
https://www.readbyqxmd.com/read/28185242/long-acting-muscarinic-antagonist-lama-plus-long-acting-beta-agonist-laba-versus-laba-plus-inhaled-corticosteroid-ics-for-stable-chronic-obstructive-pulmonary-disease-copd
#6
REVIEW
Nobuyuki Horita, Atsushi Goto, Yuji Shibata, Erika Ota, Kentaro Nakashima, Kenjiro Nagai, Takeshi Kaneko
BACKGROUND: Three classes of inhaler medications are used to manage chronic obstructive pulmonary disease (COPD): long-acting beta-agonists (LABA), long-acting muscarinic antagonists (LAMA), and inhaled corticosteroids (ICS). When two classes of medications are required, LAMA plus LABA (LAMA+LABA) and LABA plus ICS (LABA+ICS) are often selected because these combinations can be administered via a single medication device. The previous Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidance recommended LABA+ICS as the first-line treatment for managing stable COPD in high-risk people of categories C and D...
February 10, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28182569/chronic-obstructive-pulmonary-disease-exacerbation-and-inhaler-device-handling-real-life-assessment-of-2935-patients
#7
Mathieu Molimard, Chantal Raherison, Severine Lignot, Aurelie Balestra, Stephanie Lamarque, Anais Chartier, Cecile Droz-Perroteau, Regis Lassalle, Nicholas Moore, Pierre-Olivier Girodet
Acute exacerbations of chronic obstructive pulmonary disease (COPD) can be prevented by inhaled treatment. Errors in inhaler handling, not taken into account in clinical trials, could impact drug delivery and minimise treatment benefit. We aimed to assess real-life inhaler device handling in COPD patients and its association with COPD exacerbations.To this end, 212 general practitioners and 50 pulmonologists assessed the handling of 3393 devices used for continuous treatment of COPD in 2935 patients. Handling errors were observed in over 50% of handlings, regardless of the device used...
February 2017: European Respiratory Journal: Official Journal of the European Society for Clinical Respiratory Physiology
https://www.readbyqxmd.com/read/28167512/e-cigarettes-and-dripping-among-high-school-youth
#8
Suchitra Krishnan-Sarin, Meghan Morean, Grace Kong, Krysten W Bold, Deepa R Camenga, Dana A Cavallo, Patricia Simon, Ran Wu
BACKGROUND: Electronic cigarettes (e-cigarettes) electrically heat and vaporize e-liquids to produce inhalable vapors. These devices are being used to inhale vapors produced by dripping e-liquids directly onto heated atomizers. The current study conducts the first evaluation of the prevalence rates and reasons for using e-cigarettes for dripping among high school students. METHODS: In the spring of 2015, students from 8 Connecticut high schools (n = 7045) completed anonymous surveys that examined tobacco use behaviors and perceptions...
February 6, 2017: Pediatrics
https://www.readbyqxmd.com/read/28167004/e-cigarettes-an-update-on-considerations-for-the-otolaryngologist
#9
REVIEW
Sneh Biyani, Craig S Derkay
PURPOSE: We provide an update in the literature and national regulations regarding electronic cigarettes with special attention to the pediatric population. BACKGROUND: Electronic nicotine delivery systems (ENDS) are handheld battery operated devices that vaporize nicotine-containing liquids for inhalation. Use of these products has dramatically increased over the last several years, particularly among the youth. ENDS are being marketed with advertising techniques and flavors which appeal to the adolescent and young adult population...
March 2017: International Journal of Pediatric Otorhinolaryngology
https://www.readbyqxmd.com/read/28161666/cellular-internalization-and-transport-of-biodegradable-polyester-dendrimers-on-a-model-of-the-pulmonary-epithelium-and-their-formulation-in-pressurized-metered-dose-inhalers
#10
Rodrigo S Heyder, Qian Zhong, Reinaldo C Bazito, Sandro R P da Rocha
The purpose of this study was to evaluate the effect of generation and surface PEGylation of degradable polyester-based dendrimers nanocarriers on their interactions with an in vitro model of the pulmonary epithelium as well as to assess the ability to formulate such carriers in propellant-based, portable oral-inhalation devices to determine their potential for local and systemic delivery of drugs to and through the lungs. Hydroxyl (-OH) terminated polyester dendrimers of generation 3 and 4 (G3, and G4) were synthesized using a divergent approach...
February 1, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28150135/perioperative-hyperalgesia-and-associated-clinical-factors
#11
REVIEW
Obaid S Malik, Alan D Kaye, Richard D Urman
PURPOSE OF REVIEW: Pain has an important evolutionary role because it serves as an essential warning device to damaging stimuli. The perioperative setting is a unique environment where clinicians must accurately diagnose and address the source of pain. Modern-day perioperative pain control continues to be unsatisfactory. Nearly half of all surgical patients have moderate to severe pain postoperatively, and 24% experience inadequate pain relief. Furthermore, over half of the patients develop chronic pain after thoracotomies, mastectomies, and limb amputation surgeries...
January 2017: Current Pain and Headache Reports
https://www.readbyqxmd.com/read/28149256/extensive-burn-injury-caused-by-fundamental-electronic-cigarette-design-flaw
#12
S Bohr, F Almarzouqi, N Pallua
Currently, electronic cigarette (EC) devices are widely used as an alternative to conventional smoking. The underlying technical principle is an electric coil-based vaporizer unit, which vaporizes various solutions for inhalation purposes with a rechargeable lithium battery unit as power source. We report a case of extensive burn injury resulting from the thermal explosion of a battery unit within an EC device. Though internal thermal instabilities of lithium ion batteries are a known safety issue, the unique feature here is a pronounced amplification of the extent of burn injury due to an additional scalding burn mechanism that resulted from heating of the liquid reservoir adjacent to the battery...
September 30, 2016: Annals of Burns and Fire Disasters
https://www.readbyqxmd.com/read/28145828/an-industry-update-what-is-new-in-the-field-of-therapeutic-delivery-this-month
#13
Elaine Harris
The present industry update covers the period of 1-30 November 2016, with information sourced primarily from company press releases, regulatory and patent agencies, scientific literature and various news websites. There was positive news on the clinical trials front for both EyeNovia and Glaxo SmithKline, but this month also saw Innocol release disappointing Phase IIb results for its Cogenzia product. In regulatory news, it was announced that the US FDA indicated that EyeGate may use the 510(k) De Novo Path for their device, the Ocular Bandage Gel...
January 2017: Therapeutic Delivery
https://www.readbyqxmd.com/read/28137488/patient-characteristics-associated-with-poor-inhaler-technique-among-a-cohort-of-patients-with-copd
#14
Anne C Melzer, Bijan J Ghassemieh, Suzanne E Gillespie, Peter K Lindenauer, Mary Ann McBurnie, Richard A Mularski, Edward T Naureckas, William M Vollmer, David H Au
BACKGROUND: Inhaled therapies are the cornerstone of pharmacologic management for COPD. Each device requires a unique series of steps to be most effective, making appropriate instruction in inhaler technique a key part of the management of COPD. OBJECTIVES: Examine characteristics of patients and devices associated with poor technique among patients with COPD. METHODS: Cross-sectional study of subjects with COPD using at least one of: metered dose inhaler, Advair Diskus, Spiriva Handihaler, identified from the COPD Outcomes-based Network for Clinical Effectiveness and Research Translation (CONCERT) registry...
February 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28137486/how-many-instructions-are-required-to-correct-inhalation-errors-in-patients-with-asthma-and-chronic-obstructive-pulmonary-disease
#15
Yotaro Takaku, Kazuyoshi Kurashima, Chie Ohta, Takashi Ishiguro, Naho Kagiyama, Tsutomu Yanagisawa, Noboru Takayanagi
In the treatment of asthma and chronic obstructive pulmonary disease (COPD), errors in handling and wrong techniques in using inhalation devices are associated with poor disease control. The aim of this study was to evaluate the number of instructions that are necessary to minimize errors in using pressurized metered-dose inhaler (pMDI), soft mist inhaler (SMI), and dry powder inhaler (DPI). Among 216 patients with asthma (n = 135) and COPD (n = 81), we studied 245 cases that used different types of inhalation devices...
February 2017: Respiratory Medicine
https://www.readbyqxmd.com/read/28129353/the-humidity-in-a-low-flow-dr%C3%A3-ger-fabius-anesthesia-workstation-with-or-without-thermal-insulation-or-a-heat-and-moisture-exchanger-a-prospective-randomized-clinical-trial
#16
Sergius A R de Oliveira, Lorena M C Lucio, Norma S P Modolo, Yoko Hayashi, Mariana G Braz, Lídia R de Carvalho, Leandro G Braz, José Reinaldo C Braz
BACKGROUND: During anesthesia, as compared with intensive care, the time of the tracheal intubation is much shorter. An inhaled gas minimum humidity of 20 mgH2O.L-1 is recommended to reduce the deleterious effects of dry gas on the airways during anesthesia with tracheal intubation. The Fabius GS Premium® anesthesia workstation (Dräger Medical, Lübeck, Germany) has a built-in hotplate to heat gases in the breathing circuit. A heat and moisture exchanger (HME) is used to further heat and humidify the inhaled gas...
2017: PloS One
https://www.readbyqxmd.com/read/28123861/thermal-injury-patterns-associated-with-electronic-cigarettes
#17
Alisha Z Jiwani, James F Williams, Julie A Rizzo, Kevin K Chung, Booker T King, Leopoldo C Cancio
E-cigarettes are typically lithium-ion battery-operated devices that simulate smoking by heating a nicotine-solution into a vapor that the user inhales. E-cigarette use is becoming rapidly popular as an alternative to traditional cigarette smoking. This report describes an emerging problem associated with e-cigarettes, consisting of 10 thermally injured patients seen at a single burn center over a 2-year period from 2014 to 2016. Our cohort was comprised mainly of young adults who sustained mixed partial and full thickness burns as a result of e-cigarette-related explosions...
2017: International Journal of Burns and Trauma
https://www.readbyqxmd.com/read/28118240/incorporating-technology-to-advance-asthma-controller-adherence
#18
William C Anderson
PURPOSE OF REVIEW: Technological innovations, including text messaging, smart phone applications, and electronic monitoring devices, aimed at improving asthma controller adherence are being rapidly introduced both into clinical care and directly marketed to patients. This review analyzes recent clinical trials implementing these interventions, with a focus on their benefits and shortcomings. RECENT FINDINGS: Poor medication adherence continues to exert significant morbidity on patients with asthma...
January 21, 2017: Current Opinion in Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28114736/cromolyn-sodium-for-the-prevention-of-chronic-lung-disease-in-preterm-infants
#19
REVIEW
Geraldine Ng, Arne Ohlsson
BACKGROUND: This is an update of a review last published by Cochrane in June 2012 entitled "Cromolyn sodium for the prevention of chronic lung disease in preterm infants", which included two studies. This 2016 update identified no further studies.Chronic lung disease (CLD) frequently occurs in preterm infants and has a multifactorial aetiology including inflammation. Cromolyn sodium is a mast cell stabiliser that inhibits neutrophil activation and neutrophil chemotaxis and therefore may have a role in the prevention of CLD...
January 23, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28110057/real-life-outcomes-for-patients-with-asthma-prescribed-spacers-for-use-with-either-extrafine-or-fine-particle-inhaled-corticosteroids
#20
Theresa W Guilbert, Gene Colice, Jonathan Grigg, Wim van Aalderen, Richard J Martin, Elliot Israel, Dirkje S Postma, Nicolas Roche, Wanda Phipatanakul, Elizabeth V Hillyer, Jennifer M Evans, Myrna B Dolovich, David B Price
BACKGROUND: Spacers are often used with pressurized metered-dose inhalers (pMDIs) to eliminate the need for coordinating inhalation with actuation. OBJECTIVE: To investigate the real-life effectiveness of spacers prescribed for use with either extrafine- or fine-particle inhaled corticosteroids (ICSs). METHODS: This historical matched cohort study examined anonymous medical record data over 2 years (1-year baseline, 1-year outcome) for patients with asthma aged 12 to 80 years initiating ICSs by pMDI with or without prescribed spacer...
January 18, 2017: Journal of Allergy and Clinical Immunology in Practice
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