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Asthma trials

Matteo Bonini
PURPOSE OF REVIEW: Asthma is the most prevalent chronic respiratory disease and represents a relevant socioeconomic burden. e-Health has the potential to improve disease control and adherence to treatment in asthmatic patients. Available data are, however, scarce and inconsistent limiting the use of e-health in clinical practice. This article aims to provide a systematic review of the literature published in the last year regarding the real place and impact of e-health in the management of asthma...
October 18, 2016: Current Opinion in Pulmonary Medicine
Christian Bime, Joe K Gerald, Christine Y Wei, Janet T Holbrook, William G Teague, Robert A Wise, Lynn B Gerald
The childhood Asthma-Control Test (C-ACT) is validated for assessing asthma control in paediatric asthma. Among children aged 4-11 years, the C-ACT requires the simultaneous presence of both parent and child. There is an unmet need for a tool that can be used to assess asthma control in children when parents or caregivers are not present such as in the school setting. We assessed the psychometric properties and estimated the minimally important difference (MID) of the C-ACT and a modified version, comprising only the child responses (C-ACTc)...
October 20, 2016: NPJ Primary Care Respiratory Medicine
Justin C Chia, P Régine Mydlarski
PURPOSE: Omalizumab is a recombinant humanized monoclonal antibody that inhibits the binding of IgE to the high-affinity IgE receptor (FceRI) on the surface of mast cells and basophils. Omalizumab has been approved for use in asthma, and new reports show promise in a variety of dermatologic diseases. Herein, we review the literature on omalizumab in dermatology and discuss the safety, efficacy and mechanisms of action for this emerging therapy. MATERIALS AND METHODS: PubMED, MEDLINE, and Embase databases were searched for the period January 1, 1990, to September 1, 2016...
October 19, 2016: Journal of Dermatological Treatment
Zhantao Su, Rui Li, Zhongtao Gai
OBJECTIVE: This study aimed to evaluate the efficacy of intravenous (IV) and nebulized magnesium sulfate in acute asthma in children. METHODS: The PubMed, Cochrane Library, and EMBASE databases were searched. Randomized controlled trials and quasi-randomized controlled trials of IV and nebulized magnesium sulfate in pediatric acute asthma were included. The outcomes subject to meta-analysis were pulmonary function, hospitalization, and further treatment. If statistical heterogeneity was significant, random-effects models were used for meta-analysis, otherwise, fixed-effects models were applied...
October 4, 2016: Pediatric Emergency Care
Maxime Luu, Marc Bardou, Philippe Bonniaud, Françoise Goirand
Omalizumab is a subcutaneously administrated monoclonal anti-IgE antibody indicated in adults, adolescents and children 6 years of age and older with moderate to severe allergic asthma uncontrolled by conventional pharmacological treatments and sensitization to at least one perennial allergen. Area covered: This drug evaluation summarizes published data on pharmacokinetic and pharmacodynamic properties of omalizumab, on clinical efficacy and safety, including real-world evidence, and provides a medico-economic evaluation of the drug...
October 17, 2016: Expert Opinion on Drug Metabolism & Toxicology
Joanne E Sordillo, Yanjiao Zhou, Michael J McGeachie, John Ziniti, Nancy Lange, Nancy Laranjo, Jessica R Savage, Vincent Carey, George O'Connor, Megan Sandel, Robert Strunk, Leonard Bacharier, Robert Zeiger, Scott T Weiss, George Weinstock, Diane R Gold, Augusto A Litonjua
BACKGROUND: The gut microbiome in infancy influences immune system maturation, and may have an important impact allergic disease risk. OBJECTIVE: To determine how prenatal and early life factors impact the gut microbiome in a relatively large, ethnically diverse study population of infants at 3-6 months of age, who were enrolled in VDAART, a clinical trial of vitamin D supplementation in pregnancy to prevent asthma and allergies in offspring. METHODS: We performed 16S rRNA gene sequencing on 333 infants' stool samples...
October 13, 2016: Journal of Allergy and Clinical Immunology
Patricia D Freitas, Palmira G Ferreira, Aline G Silva, Rafael Stelmach, Regina M Carvalho-Pinto, Frederico L A Fernandes, Marcio C Mancini, Maria N Sato, Milton A Martins, Celso R F Carvalho
RATIONALE: Clinical control is difficult to achieve in obese patients with asthma. Bariatric surgery has been recommended for weight-loss and to improve asthma control; however, the benefits of nonsurgical interventions have been poorly investigated. OBJECTIVE: To examine the effect of exercise training in a weight-loss program on asthma control, quality of life, inflammatory biomarkers and lung function. METHODS: Fifty-five obese patients with asthma were randomly assigned to either a weight-loss program + exercise (WL+E group, n=28) or a weight-loss program + sham (WL+S group, n=27) group, where the weight-loss program included nutrition (caloric restriction) and psychological therapies...
July 19, 2016: American Journal of Respiratory and Critical Care Medicine
Deborah Q Shelef, Cynthia Rand, Randi Streisand, Ivor B Horn, Kabir Yadav, Lisa Stewart, Naja Foushee, Damian Waters, Stephen J Teach
BACKGROUND: Stakeholder engagement has the potential to develop research interventions which are responsive to patient and provider preferences. This approach contrasts with traditional models of clinical research, in which researchers determine the study's design. OBJECTIVE: This article describes the impact of stakeholder engagement on the design of a randomized trial of an intervention designed to improve child asthma outcomes by reducing parental stress. METHODS: The study team developed and implemented a stakeholder engagement process that provided iterative feedback regarding the study design, patient-centered outcomes, and intervention...
October 12, 2016: Journal of Allergy and Clinical Immunology
Michele Miraglia Del Giudice, Annalisa Allegorico
The role of vitamin D in calcium and phosphate homeostasis is well known; however, in addition to traditional functions, vitamin D modulates a variety of processes, and evidence shows that it has an important role in different allergic diseases such as asthma, atopic dermatitis, and food allergy. Vitamin D acts by binding to the vitamin D receptor, which is present in a variety of tissues; for this reason it is considered a hormone. One of the most important functions is to modulate the immune system response, both innate and adaptive, by suppressing Th2-type response and increasing natural killer cells...
November 2016: Journal of Clinical Gastroenterology
Niran J Amar, Tulin Shekar, Tracey A Varnell, Anish Mehta, George Philip
OBJECTIVES: Mometasone furoate (MF), delivered via dry-powder inhaler (DPI) QD in the evening (PM), is a treatment option for pediatric patients with asthma. We evaluated MF delivered via a metered-dose inhaler (MDI), in children ages 5-11 years with persistent asthma. METHODS: This was a 12-week double-blind, double-dummy, placebo-controlled trial. Pateints were randomized to the following treatments: MF-MDI 50 mcg BID, MF-MDI 100 mcg BID, MF-MDI 200 mcg BID, MF-DPI 100 mcg QD PM, and placebo...
October 14, 2016: Pediatric Pulmonology
Saloumeh Kadkhodayan Fischer, Melissa Cheu, Kun Peng, John Lowe, James Araujo, Elaine Murray, Dana McClintock, John Matthews, Patricia Siguenza, An Song
Host cell proteins are manufacturing process-related impurities that may co-purify with the product despite extensive efforts to optimize the purification process. The risks associated with these impurities can vary and may be patient and/or therapeutic dependent. Therefore, it is critical to monitor and control the levels of these impurities in products and their potential impact on safety and efficacy. Lebrikizumab is a humanized immunoglobulin G4 monoclonal antibody (mAb) that binds specifically to soluble interleukin 13...
October 13, 2016: AAPS Journal
Andrew Skeggs, Tricia McKeever, Lelia Duley, Eleanor Mitchell, Lucy Bradshaw, Kevin Mortimer, Samantha Walker, Steve Parrott, Andrew Wilson, Ian Pavord, Chris Brightling, Mike Thomas, David Price, Graham Devereux, Bernard Higgins, Tim Harrison, Rebecca Haydock
BACKGROUND: Asthma is one of the commonest chronic diseases in the UK. Acute exacerbations of asthma are unpredictable, disruptive and frightening. They cause considerable morbidity and account for a large component of the health service costs of asthma. The widespread use of an asthma self-management plan, designed to encourage disease monitoring and timely intervention, can reduce exacerbations and is, therefore, recommended for all patients with asthma. Unfortunately, the majority of patients are not provided with such a plan...
October 13, 2016: Trials
Judith Riley, Anna Hunt, Alice McDouall, Steve Waqanivavalagi, Irene Braithwaite, Mark Weatherall, Thorsten Stanley, Richard Beasley, Edwin A Mitchell, Stuart R Dalziel
AIM: To undertake a randomised controlled trial (RCT) of paracetamol versus ibuprofen use during infancy to determine if paracetamol is associated with an increased risk of developing asthma, the preferred method of recruitment needs to be determined. We assessed three different recruitment domains to determine the likely enrolment rates of newborn infants into a three-year or six-year RCT of paracetamol versus ibuprofen and the development of asthma symptoms. The proposed RCT would require 1,806 participants...
October 14, 2016: New Zealand Medical Journal
José Serrano-Pariente, Vicente Plaza, Joan B Soriano, Mercè Mayosc, Antolín López-Viña, César Picado, Laura Vigil
BACKGROUND: Continuous positive airway pressure (CPAP) in asthma patients with concomitant obstructive sleep apnea syndrome (OSAS) seems to have a favorable impact on asthma, but data are inconsistent due to methodological limitations of previous studies METHODS: Prospective, multicenter study. We examined asthma outcomes after six months of CPAP in 99 adult asthma patients (mean age 57 years) with OSAS (respiratory disturbance index ≥20). Asthma control and quality of life were assessed with the Asthma Control Questionnaire (ACQ) and the Mini Asthma Quality of Life Questionnaire (MiniAQLQ), respectively...
October 12, 2016: Allergy
Nikita Kohli, Dana DeCarlo, Nira A Goldstein, Joshua Silverman
OUTCOME OBJECTIVE: For over fifty years, otolaryngologists, allergists, and immunologists have debated the effect of adenoidectomy or adenotonsillectomy on asthma outcomes in children. Although some have suggested that adenotonsillectomy may contribute to the subsequent development of asthma in children, others have argued that a common mechanism may cause both upper and lower airway disease, and that children who have symptoms severe enough to warrant adenotonsillectomy are also at increased risk of asthma and atopic disease...
November 2016: International Journal of Pediatric Otorhinolaryngology
Stefan Palme, Robert H Christenson, Saeed A Jortani, Richard E Ostlund, Ruediger Kolm, Guido Kopal, Ruediger P Laubender
OBJECTIVE: The multifunctional cytokine IL-13 is thought to play a central role in Type 2 inflammation in asthma. Serum periostin has been explored as a candidate biomarker for evaluating IL-13 activity in the airway. We describe the technical performance characteristics of a novel, fully automated immunoassay for the determination of periostin in serum. DESIGN AND METHODS: Limit of blank [LoB], limit of detection [LoD] and limit of quantitation [LoQ], linearity, precision and reproducibility across sites and lots were evaluated according to Clinical and Laboratory Standards Institute guidelines...
October 8, 2016: Clinical Biochemistry
Ronen Bar-Yoseph, Nir Kugelman, Galit Livnat, Michal Gur, Fahed Hakim, Vered Nir, Lea Bentur
BACKGROUND AND OBJECTIVES: Asthma is a chronic inflammatory disorder requiring intermittent or continuous anti-inflammatory therapy. Patients often turn to alternative treatments as complements or replacements to conventional treatments. We aimed to evaluate the effect of salt room chambers (halotherapy) on bronchial hyper-responsiveness (BHR), fractional exhaled nitric oxide (FeNO), and quality of life in children with asthma. PATIENTS AND METHODS: Children aged 5-13 years with a clinical diagnosis of mild asthma not receiving anti-inflammatory therapy...
October 10, 2016: Pediatric Pulmonology
Moisés A Calderón, Carmen Vidal, Pablo Rodríguez Del Río, Jocelyne Just, Oliver Pfaar, Ana I Tabar, Inmaculada Sánchez-Machín, Petra Bubel, Jesus Borja, Peter Eberle, Rainer Reiber, Michel Bouvier, Alain Lepelliez, Ludger Klimek, Pascal Demoly
BACKGROUND: Outside clinical trials, data on systemic reactions (SRs) due to allergen immunotherapy (AIT) are scarce. METHODS: A prospective, longitudinal, web-based survey of "real-life" respiratory allergen immunotherapy (AIT) clinical practice was conducted in France, Germany and Spain. SRs were recorded and coded according to the Medical Dictionary for Regulatory Activities (MedDRA) and risk factors associated with SRs were identified. RESULTS: A total of 4,316 patients (corresponding to 4,363 ongoing courses of AIT) were included...
October 8, 2016: Allergy
Amal Al-Garawi, Vincent J Carey, Divya Chhabra, Hooman Mirzakhani, Jarrett Morrow, Jessica Lasky-Su, Weiliang Qiu, Nancy Laranjo, Augusto A Litonjua, Scott T Weiss
BACKGROUND: Patterns of gene expression of human pregnancy are poorly understood. In a trial of vitamin D supplementation in pregnant women, peripheral blood transcriptomes were measured longitudinally on 30 women and used to characterize gene co-expression networks. OBJECTIVE: Studies suggest that increased maternal Vitamin D levels may reduce the risk of asthma in early life, yet the underlying mechanisms have not been examined. In this study, we used a network-based approach to examine changes in gene expression profiles during the course of normal pregnancy and evaluated their association with maternal Vitamin D levels...
2016: PloS One
Ching Kuo Tan, Gui Quan Say, James B Geake
Tiotropium bromide is a long-acting inhaled muscarinic antagonist used in patients with chronic respiratory disease. It has been available since 2002 as a single-dose dry powder formulation via the HandiHaler(®) dry powder inhaler (DPI) device, and since 2007 as the Respimat(®) SoftMist™ Inhaler (SMI). The latter is a novel method of medication delivery that utilizes a multidose aqueous solution to deliver the drug as a fine mist. Potential benefits include more efficient drug deposition throughout the respiratory tract, reduced systemic exposure, and greater ease of use and patient satisfaction compared with the use of HandiHaler DPI...
2016: Therapeutics and Clinical Risk Management
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