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https://www.readbyqxmd.com/read/29679606/regulatory-pitfalls-and-opportunities-when-repurposing-for-inhalation-therapy
#1
Svetlana Lyapustina
This article reviews regulatory considerations for companies wishing to develop drugs for delivery via the respiratory tract (e.g., by oral inhalation or intranasally) using molecules previously approved for a different therapeutic indication and/or a different delivery route. Conceptually, such repurposing has many medical and business advantages, but turning promising ideas into real products requires overcoming a number of practical challenges. Obtaining regulatory approval to market a candidate product comes at the end of a product development, but being aware of the regulatory requirements is necessary before the development even starts...
April 18, 2018: Advanced Drug Delivery Reviews
https://www.readbyqxmd.com/read/29679489/data-driven-motion-correction-will-replace-motion-tracking-devices-in-molecular-imaging-guided-radiation-therapy-treatment-planning
#2
Adam Kesner, Tinsu Pan, Habib Zaidi
The last decade has seen abundant literature demonstrating the advantages of hybrid imaging modalities combining morphological and molecular imaging in clinical oncology. Commercial systems merging SPECT and CT, PET and CT or PET and MRI are now widely used in the clinic and have had significant impact on patient management. Ultimately, molecular imaging-guided radiotherapy holds the promise of improved definition of tumor target volumes. However, respiratory motion management remains one of the main challenges of this technique...
April 21, 2018: Medical Physics
https://www.readbyqxmd.com/read/29678900/prevention-of-exacerbations-in-patients-with-stable-non-cystic-fibrosis-bronchiectasis-a-systematic-review-and-meta-analysis-of-pharmacological-and-non-pharmacological-therapies
#3
Abd Moain Abu Dabrh, Adam T Hill, Claudia C Dobler, Noor Asi, Wigdan H Farah, Qusay Haydour, Zhen Wang, Khalid Benkhadra, Larry J Prokop, Mohammad Hassan Murad
BACKGROUND: Several pharmacological and non-pharmacological therapies are used to treat stable bronchiectasis of non-cystic fibrosis (CF) aetiology. OBJECTIVE: We conducted a systematic review and meta-analysis to assess the evidence of the effectiveness of pharmacological and non-pharmacological treatment options in patients with stable non-CF bronchiectasis with a focus on reducing exacerbations. STUDY SELECTION: Multiple databases were searched through September 2017...
April 20, 2018: BMJ evidence-based medicine
https://www.readbyqxmd.com/read/29678874/mitochondrial-morphological-and-functional-reprogramming-following-cd137-4-1bb-co-stimulation
#4
Alvaro Teijeira, Sara Labiano, Saray Garasa, Inaki Etxeberria, Eva Santamaria, Ana Rouzaut, Michel Enamorado, Arantza Azpilikueta, Susana Inoges, Elixabet Bolanos-Mateo, Maria Angela Aznar, Alfonso R Sanchez-Paulete, David Sancho, Ignacio Melero
T and NK lymphocytes express CD137 (4-1BB), a costimulatory receptor of the TNFR family whose function is exploitable for cancer immunotherapy. Mitochondria regulate the function and survival of T lymphocytes. Herein, we show that CD137 costimulation provided by agonist mAb and CD137L (4-1BBL) induced mitochondria enlargement that resulted in enhanced mitochondrial mass and transmembrane potential in human and mouse CD8+ T cells. Such mitochondrial changes increased T-cell respiratory capacities and were critically dependent on mitochondrial fusion protein OPA-1 expression...
April 20, 2018: Cancer Immunology Research
https://www.readbyqxmd.com/read/29676650/the-pluripotency-factor-musashi-2-is-a-novel-target-for-lung-cancer-therapy
#5
Mary R Zhang, Sichuan Xi, Vivek Shukla, Julie A Hong, Haobin Chen, Yin Xiong, R Taylor Ripley, Chuong D Hoang, David S Schrump
Previously we reported that mithramycin represses multiple pathways critical for stem cell signaling and pluripotency in lung cancer cells. This phenomenon coincided with decreased side population fraction and dramatic dose-dependent growth arrest of lung cancer cells in vitro and in vivo. In the present study, microarray, quantitative reverse transcriptase polymerase chain reaction and immunoblot experiments were performed to further examine the effects of mithramycin on stem cell gene expression in lung cancer cells...
April 2018: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/29676638/identification-of-novel-targets-for-lung-cancer-therapy-using-an-induced-pluripotent-stem-cell-model
#6
Vivek Shukla, Mahadev Rao, Hongen Zhang, Jeanette Beers, Darawalee Wangsa, Danny Wangsa, Floryne O Buishand, Yonghong Wang, Zhiya Yu, Holly Stevenson, Emily Reardon, Kaitlin C McLoughlin, Andrew Kaufman, Eden Payabyab, Julie A Hong, Mary Zhang, Sean R Davis, Daniel C Edelman, Guokai Chen, Markku Miettinen, Nicholas Restifo, Thomas Ried, Paul S Meltzer, David S Schrump
RATIONALE: Despite extensive studies, the genetic and epigenetic mechanisms that mediate initiation and progression of lung cancers have not been fully elucidated. Previously, we have demonstrated that via complementary mechanisms, including DNA methylation, polycomb repressive complexes, and noncoding RNAs, cigarette smoke induces stem-like phenotypes that coincide with progression to malignancy in normal respiratory epithelia as well as enhanced growth and metastatic potential of lung cancer cells...
April 2018: Annals of the American Thoracic Society
https://www.readbyqxmd.com/read/29676072/current-management-of-moderate-to-severe-atopic-dermatitis-a-survey-of-allergists-pediatric-allergists-and-dermatologists-in-korea
#7
Hye Yung Yum, Hyun Hee Kim, Hyun Jung Kim, Woo Kyung Kim, So Yeon Lee, Kapsok Li, Dong Hun Lee
PURPOSE: There is an unmet need for the treatment of moderate-to-severe atopic dermatitis (AD), leading to variation in management strategies. To investigate distinct features and treatment modalities according to physicians' specialties, we collected data on the current treatment approach to moderate-to-severe AD among allergists, pediatric allergists and dermatologists in Korea. METHODS: This questionnaire-based study was administered to physicians from the Korean Academy of Asthma, Allergy and Clinical Immunology (KAAACI), Korean Academy of Pediatric Allergy and Respiratory Disease (KAPARD), and Korean Atopic Dermatitis Association (KADA)...
May 2018: Allergy, Asthma & Immunology Research
https://www.readbyqxmd.com/read/29671652/effects-of-educated-monocytes-with-xenogeneic-mesenchymal-stem-cell-derived-conditioned-medium-in-a-mouse-model-of-chronic-asthma
#8
Hadi Esmaili Gourvarchin Galeh, Seyyed Meysam Abtahi Froushani, Nahideh Afzale Ahangaran, Siamak Naji Hadai
BACKGROUND: This study was conducted to determine the potential of the monocytes educated with rat bone marrow mesenchymal stem cell-derived conditioned medium (MCM) in ameliorating animal model of asthma. METHODS: Chronic asthma was induced in the BALB/c mice using ovalbumin (OVA) sensitization. The monocytes were isolated from blood of mice and supplemented with 50% MCM or negative control media. After 24 h, the cells were designated as "non-educated or educated"...
April 19, 2018: Immunological Investigations
https://www.readbyqxmd.com/read/29671615/patient-reported-outcomes-for-the-detection-quantification-and-evaluation-of-chronic-obstructive-pulmonary-disease-exacerbations
#9
Alex J Mackay, Konstantinos Kostikas, Lindsey Murray, Fernando J Martinez, Marc Miravitlles, Gavin Donaldson, Donald Banerji, Francesco Patalano, Jadwiga A Wedzicha
An exacerbation of Chronic Obstructive Pulmonary Disease (COPD) is an acute worsening of respiratory symptoms, accompanied by a variable degree of physiological deterioration. The traditional assessment of an exacerbation consists of the reporting of symptoms directly by the patient to a clinician and subsequent clinical assessment. It would be valuable to also gather symptom reports directly from patients and thus patient-reported outcome (PRO) tools should be ideally suited to the evaluation of COPD exacerbations...
April 19, 2018: American Journal of Respiratory and Critical Care Medicine
https://www.readbyqxmd.com/read/29671504/buprenorphine-therapy-for-opioid-use-disorder
#10
Roger Zoorob, Alicia Kowalchuk, Maria Mejia de Grubb
Opioid misuse, including the use of heroin and the overprescribing, misuse, and diversion of opioid pain medications, has reached epidemic proportions in the United States. As a result, there has been a dramatic increase in opioid use disorder and associated overdoses and deaths. Addiction is a chronic brain disease with a genetic component that affects motivation, inhibition, and cognition. Patient characteristics associated with successful buprenorphine maintenance treatment include stable or controlled medical or psychiatric comorbidities and a safe, substance-free environment...
March 1, 2018: American Family Physician
https://www.readbyqxmd.com/read/29670681/diaphragm-muscle-weakness-following-acute-sustained-hypoxic-stress-in-the-mouse-is-prevented-by-pretreatment-with-n-acetyl-cysteine
#11
Andrew J O'Leary, Sarah E Drummond, Deirdre Edge, Ken D O'Halloran
Oxygen deficit (hypoxia) is a major feature of cardiorespiratory diseases characterized by diaphragm dysfunction, yet the putative role of hypoxic stress as a driver of diaphragm dysfunction is understudied. We explored the cellular and functional consequences of sustained hypoxic stress in a mouse model. Adult male mice were exposed to 8 hours of normoxia, or hypoxia (FiO2  = 0.10) with or without antioxidant pretreatment (N-acetyl cysteine, 200 mg/kg i.p.). Ventilation and metabolism were measured. Diaphragm muscle contractile function, myofibre size and distribution, gene expression, protein signalling cascades, and oxidative stress (TBARS) were determined...
2018: Oxidative Medicine and Cellular Longevity
https://www.readbyqxmd.com/read/29670531/beat-to-beat-variability-of-ventricular-action-potential-duration-oscillates-at-low-frequency-during-sympathetic-provocation-in-humans
#12
Bradley Porter, Stefan van Duijvenboden, Martin J Bishop, Michele Orini, Simon Claridge, Justin Gould, Benjamin J Sieniewicz, Baldeep Sidhu, Reza Razavi, Christopher A Rinaldi, Jaswinder S Gill, Peter Taggart
Background: The temporal pattern of ventricular repolarization is of critical importance in arrhythmogenesis. Enhanced beat-to-beat variability (BBV) of ventricular action potential duration (APD) is pro-arrhythmic and is increased during sympathetic provocation. Since sympathetic nerve activity characteristically exhibits burst patterning in the low frequency range, we hypothesized that physiologically enhanced sympathetic activity may not only increase BBV of left ventricular APD but also impose a low frequency oscillation which further increases repolarization instability in humans...
2018: Frontiers in Physiology
https://www.readbyqxmd.com/read/29670380/emerging-treatment-options-for-acute-bacterial-skin-and-skin-structure-infections-focus-on-intravenous-delafloxacin
#13
REVIEW
Elda Righi, Alessia Carnelutti, Antonio Vena, Matteo Bassetti
The increase in hospitalization due to acute bacterial skin and skin structure infections (ABSSSI) caused by resistant pathogens supports the need for new treatment options. Antimicrobial options for ABSSSI that provide broad-spectrum coverage, including gram-negative pathogens and multidrug-resistant gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), are limited. Delafloxacin is a novel fluoroquinolone available as intravenous and oral formulations and is characterized by an increased efficacy in acidic environments and activity on bacterial biofilm...
2018: Infection and Drug Resistance
https://www.readbyqxmd.com/read/29669956/nosocomial-pneumonia-search-for-an-empiric-and-effective-antibiotic-regimen-in-high-burden-tertiary-care-centre
#14
Nitin Gupta, Manish Soneja, Yogiraj Ray, Monalisa Sahu, Kutty Sharada Vinod, Arti Kapil, Ashutosh Biswas, Naveet Wig, Rita Sood
The clinical practice guidelines on nosocomial pneumonia recommends an empirical regimen that would work in 95% of the patients based on the local antibiogram. The aim of the study was development of an antibiogram for guiding empiric therapy in settings with high prevalence of multi-drug resistant organisms. A retrospective review of electronic health records (e-hospital portal) was done to analyze all respiratory isolates from patients admitted in medical wards and intensive care unit between May 2016 and May 2017...
April 17, 2018: Drug Discoveries & Therapeutics
https://www.readbyqxmd.com/read/29669663/nonprescription-medications-for-respiratory-symptoms-facts-and-marketing-fictions
#15
Miles Weinberger, Leslie Hendeles
BACKGROUND: There are many nonprescription (over-the-counter [OTC]) medications available on pharmacy shelves marketed for relief of respiratory symptoms. The number of such medications has been increasing. OBJECTIVE: This review provides an evidence-based examination of OTC products used for respiratory symptoms. METHODS: Antihistamines, decongestants, mucolytics, antitussives, and intranasal steroids were selected as the most common OTC medications taken by adults and children for various respiratory symptoms...
May 1, 2018: Allergy and Asthma Proceedings:
https://www.readbyqxmd.com/read/29669532/pulmonary-lymphangioleimyomatosis-and-systemic-lupus-erythematosus-in-a-menopausal-woman
#16
Hong Hong, Ruiheng Yang, Xiuzhen Li, Mengjun Wang, Zhongchao Ma
BACKGROUND: Pulmonary lymphangioleimyomatosis (PLAM) is a rare disease involving lung. PLAM primarily affects young women, a characteristic it shares with systemic lupus erythematosus (SLE). Estrogen has long been assumed to play an important role both in PLAM and SLE. We report a menopausal woman, who was found to have PLAM 1 year after she was diagnosed with SLE. Her chest radiograph was normal in the early phase of SLE. CASE PRESENTATION: A 52-year-old Chinese woman was referred to our hospital in August 2014 because of swelling in both legs...
April 18, 2018: BMC Nephrology
https://www.readbyqxmd.com/read/29667512/alternative-technique-to-transfer-jaw-relations-for-custom-mandibular-advancement-devices-a-case-report
#17
Filiz Keyf, Defne Burduroğlu, Selma Fırat Güven, Bülent Çiftçi
Background Oral appliance therapy for obstructive sleep apnea can be helpful in mild and moderate cases. This clinical report evaluates the efficacy of a protocol that predicts an optimal jaw position and describes the response of a young OSA patient to treatment. Clinical Presentation A 27-year-old woman was diagnosed with moderate OSA and had an apnea-hypopnea index (AHI) of 25.8/hr. In order to fabricate a custom device, an alternative procedure to determine the optimal protrusion and vertical positioning of the jaw was applied...
April 18, 2018: Cranio: the Journal of Craniomandibular Practice
https://www.readbyqxmd.com/read/29666726/-nocardia-spp-pneumonia-in-a-solid-organ-recipient-role-of-linezolid
#18
George Mwandia, Hari Polenakovik
We describe a rare infection with Nocardia spp. ( N. pseudobrasiliensis species identification based on high-performance liquid chromatography analysis) in a 68-year-old renal transplant recipient. He presented with pneumonia complicated by hypoxic respiratory failure. He was allergic to sulphonamides. He was initially successfully treated with linezolid. However, he suffered severe sensory neuropathy after 4 months of therapy, necessitating linezolid cessation and completion of treatment with azithromycin...
2018: Case Reports in Infectious Diseases
https://www.readbyqxmd.com/read/29666710/acute-chest-syndrome-progressing-to-ards-in-a-patient-of-25-week-gestation
#19
Jefferson Chambers, Nichole Smith, Matthew Sehring, Subramanyam Chittivelu
Acute chest syndrome is a complication of sickle cell disease and represents the highest cause of mortality in those afflicted with the disorder. Pregnancy represents an increased risk for complications of sickle cell disease in both the mother and fetus. We present a case of a 20-year-old patient with known sickle cell disease who was at 25-week gestation and developed acute chest syndrome refractory to conventional therapies and requiring emergency cesarean section. Following delivery, the patient developed acute respiratory distress syndrome (ARDS) requiring extracorporeal membrane oxygenation (ECMO)...
2018: Case Reports in Critical Care
https://www.readbyqxmd.com/read/29666294/laryngeal-responses-to-mechanically-assisted-cough-in-progressing-amyotrophic-lateral-sclerosis
#20
Tiina M Andersen, Astrid Sandnes, Ove Fondenes, Roy M Nilsen, Ole-Bjørn Tysnes, John-Helge Heimdal, Hege H Clemm, Thomas Halvorsen, Maria Vollsœter, Ola D Røksund
BACKGROUND: Respiratory complications represent the major cause of death in amyotrophic lateral sclerosis (ALS). Noninvasive respiratory support is the mainstay therapy, but treatment becomes challenging as the disease progresses, possibly due to a malfunctioning larynx, which is the entrance to the airways. We studied laryngeal response patterns to mechanically assisted cough (mechanical insufflation-exsufflation) as ALS progresses. METHODS: This prospective longitudinal study of 13 consecutively included subjects with ALS were followed up during 2011-2016 with repeated tests of lung function, neurological status, and laryngeal responses to mechanical insufflation-exsufflation using video-recorded flexible transnasal fiberoptic laryngoscopy...
April 17, 2018: Respiratory Care
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