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Severe asthma infection adverse event

Jos L J van der Velden, Ying Ye, James D Nolin, Sidra M Hoffman, David G Chapman, Karolyn G Lahue, Sarah Abdalla, Peng Chen, Yong Liu, Brydon Bennett, Nasreen Khalil, Donna Sutherland, William Smith, Gerald Horan, Mahmoud Assaf, Zebulun Horowitz, Rajesh Chopra, Randall M Stevens, Maria Palmisano, Yvonne M W Janssen-Heininger, Peter H Schafer
BACKGROUND: Lung remodeling and pulmonary fibrosis are serious, life-threatening conditions resulting from diseases such as chronic severe asthma and idiopathic pulmonary fibrosis (IPF). Preclinical evidence suggests that JNK enzyme function is required for key steps in the pulmonary fibrotic process. However, a selective JNK inhibitor has not been investigated in translational models of lung fibrosis with clinically relevant biomarkers, or in IPF patients. METHODS: The JNK inhibitor CC-930 was evaluated in the house dust mite-induced fibrotic airway mouse model, in a phase I healthy volunteer pharmacodynamic study, and subsequently in a phase II multicenter study of mild/moderate IPF (n = 28), with a 4-week, placebo-controlled, double-blind, sequential ascending-dose period (50 mg QD, 100 mg QD, 100 mg BID) and a 52-week open-label treatment-extension period...
December 2016: Clinical and Translational Medicine
Hiroshi Odajima, Motohiro Ebisawa, Toshikazu Nagakura, Takao Fujisawa, Akira Akasawa, Komei Ito, Satoru Doi, Koichi Yamaguchi, Toshio Katsunuma, Kazuyuki Kurihara, Takahide Teramoto, Kazuko Sugai, Mitsuhiko Nambu, Akira Hoshioka, Shigemi Yoshihara, Norio Sato, Noriko Seko, Sankei Nishima
BACKGROUND: Omalizumab is effective and well-tolerated in children with moderate to severe allergic asthma. However, the effects of long-term treatment with omalizumab in this population haven't been well investigated. The objective of this study is to evaluate the long-term safety, efficacy, pharmacokinetics and pharmacodynamics of omalizumab in children with uncontrolled severe asthma. METHODS: Thirty-eight Japanese children (aged 7-16 years) who completed the 24-week treatment core study were included in an uncontrolled extension study, in which treatment with omalizumab continued until the pediatric indication was approved in Japan (ClinicalTrials...
August 6, 2016: Allergology International: Official Journal of the Japanese Society of Allergology
Sally Wenzel, Mario Castro, Jonathan Corren, Jorge Maspero, Lin Wang, Bingzhi Zhang, Gianluca Pirozzi, E Rand Sutherland, Robert R Evans, Vijay N Joish, Laurent Eckert, Neil M H Graham, Neil Stahl, George D Yancopoulos, Mariana Louis-Tisserand, Ariel Teper
BACKGROUND: Dupilumab, a fully human anti-interleukin-4 receptor α monoclonal antibody, inhibits interleukin-4 and interleukin-13 signalling, key drivers of type-2-mediated inflammation. Adults with uncontrolled persistent asthma who are receiving medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist require additional treatment options as add-on therapy. We aimed to assess the efficacy and safety of dupilumab as add-on therapy in patients with uncontrolled persistent asthma on medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist, irrespective of baseline eosinophil count...
July 2, 2016: Lancet
Wan Najbah Nik Nabil, Wenyu Zhou, Johannah Linda Shergis, Suzi Mansu, Charlie Changli Xue, Anthony Lin Zhang
BACKGROUND: People seek Chinese medicine (CM) treatments for a variety of respiratory disorders, e.g., asthma and upper respiratory tract infection (URTI). No previous studies have reviewed the data available in medical records from Australian clinics. This study aims to identify the characteristics of patients with respiratory disorders who visited a CM teaching clinic at RMIT University in Melbourne, Australia. METHODS: Primary data from January 2010 to December 2011 were collected from patient records in a CM teaching clinic at RMIT University...
2015: Chinese Medicine
Kayleigh M Kew, Krishna Undela, Ioanna Kotortsi, Giovanni Ferrara
BACKGROUND: Asthma is a chronic disease in which inflammation of the airways causes symptomatic coughing, wheezing, and difficult breathing. The inflammation may have different underlying causes, including a reaction to infection in the lungs. Macrolides are antibiotics with antimicrobial and antiinflammatory activities that have been used long-term to control asthma symptoms. OBJECTIVES: To assess the effects of macrolides for managing chronic asthma. SEARCH METHODS: We searched the Cochrane Airways Group Specialised Register up to April 2015...
2015: Cochrane Database of Systematic Reviews
Beatrice E Ferrario, Silvia Garuti, Fulvio Braido, Giorgio W Canonica
Despite the use of antibiotics and vaccines, the frequency of respiratory tract infections is still high and these infections interest a wide range of patients, from children to aged people, including in particular these extreme categories because of the deficiency of their immune system, due to immaturity in the former case and to "immunosenescence" in the latter. For that reason immunostimulant drugs are getting more important to prevent and to attenuate infections. Pidotimod (3-L-pyroglutamyl-L-thiazolidine-4carboxylic acid) is a synthetic dipeptide with immunomodulatory properties...
2015: Clinical and Molecular Allergy: CMA
Harriet E Downing, Fran Carroll, Sara T Brookes, Sandra Hollinghurst, David Timmins, Elizabeth Orton, Kay Wang, Denise Kendrick, Paul Little, Mike V Moore, Anthony Harnden, Matthew Thompson, Margaret T May, Alastair D Hay
BACKGROUND: Acute lower respiratory tract infection (LRTI) is one of the most common conditions managed internationally and is costly to health services and patients. Despite good evidence that antibiotics are not effective for improving the symptoms of uncomplicated LRTI, they are widely prescribed, contributing to antimicrobial resistance. Many of the symptoms observed in LRTI are mediated by inflammatory processes also observed in exacerbations of asthma, for which there is strong evidence of corticosteroid effectiveness...
2015: Trials
Harriet E Downing, Fran Carroll, Sara T Brookes, Sandra Hollinghurst, David Timmins, Elizabeth Orton, Kay Wang, Denise Kendrick, Paul Little, Mike V Moore, Anthony Harnden, Matthew Thompson, Margaret T May, Alastair D Hay
BACKGROUND: Acute lower respiratory tract infection (LRTI) is one of the most common conditions managed internationally and is costly to health services and patients. Despite good evidence that antibiotics are not effective for improving the symptoms of uncomplicated LRTI, they are widely prescribed, contributing to antimicrobial resistance. Many of the symptoms observed in LRTI are mediated by inflammatory processes also observed in exacerbations of asthma, for which there is strong evidence of corticosteroid effectiveness...
December 2015: Trials
Mario Castro, James Zangrilli, Michael E Wechsler, Eric D Bateman, Guy G Brusselle, Philip Bardin, Kevin Murphy, Jorge F Maspero, Christopher O'Brien, Stephanie Korn
BACKGROUND: Elevated numbers of blood eosinophils are a risk factor for asthma exacerbations. Reslizumab is a humanised anti-interleukin 5 monoclonal antibody that disrupts eosinophil maturation and promotes programmed cell death. We aimed to assess the efficacy and safety of reslizumab in patients with inadequately controlled, moderate-to-severe asthma. METHODS: We did two duplicate, multicentre, double-blind, parallel-group, randomised, placebo-controlled phase 3 trials...
May 2015: Lancet Respiratory Medicine
Hui Fang Lim, Parameswaran Nair
Reslizumab, a neutralizing anti-IL-5 monoclonal antibody, is a promising adjunctive treatment for severe eosinophilic asthma. Monthly intravenous 3.0 mg/kg reslizumab had resulted in improvements in lung function and asthma control. It is well tolerated and common adverse events include headache, nasopharyngitis and upper respiratory tract infection. Rebound eosinophilia after cessation of reslizumab and attenuation of the treatment response with repeated dosing had been reported. Stringent selection of patients with a high eosinophil burden, who are poorly controlled despite moderate to high doses of inhaled corticosteroid, confers the most significant treatment response...
April 2015: Expert Review of Respiratory Medicine
Mark Vandewalker, Eli Meltzer, Michael Engel, Ralf Sigmund, Petra Moroni-Zentgraf, Huib Kerstjens
Asthma Posters ISESSION TYPE: Original Investigation PosterPRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 PMPURPOSE: Tiotropium Respimat®, a once-daily long-acting anticholinergic bronchodilator, has been shown to be an efficacious and well tolerated add-on to at least ICS in adult patients with symptomatic asthma. We present key safety data from five Phase III, randomized, double-blind, parallel-group trials that evaluated the efficacy and safety of once-daily tiotropium Respimat® as add-on to at least ICS versus placebo Respimat® in adult patients with symptomatic asthma...
October 1, 2014: Chest
Chiara Zecca, Matteo Caporro, Sandor Györik, Claudio Gobbi
BACKGROUND: Fingolimod (FTY) mediates bronchoconstriction by interacting with sphingosine-1-phosphate receptors. The majority of the reported adverse respiratory events occur during the first weeks of treatment. CASE PRESENTATION: A 49-year-old woman developed a life-threatening asthma attack after 6 months of continuous FTY treatment. The adverse event required prolonged hospitalization, and the patient recovered without sequelae after FTY interruption. A history of previous airway hyperreactivity and a concurrent viral respiratory infection possibly acted as predisposing factors...
2014: Patient Preference and Adherence
Lisa A Beck, Diamant Thaçi, Jennifer D Hamilton, Neil M Graham, Thomas Bieber, Ross Rocklin, Jeffrey E Ming, Haobo Ren, Richard Kao, Eric Simpson, Marius Ardeleanu, Steven P Weinstein, Gianluca Pirozzi, Emma Guttman-Yassky, Mayte Suárez-Fariñas, Melissa D Hager, Neil Stahl, George D Yancopoulos, Allen R Radin
BACKGROUND: Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13, has shown efficacy in patients with asthma and elevated eosinophil levels. The blockade by dupilumab of these key drivers of type 2 helper T-cell (Th2)-mediated inflammation could help in the treatment of related diseases, including atopic dermatitis. METHODS: We performed randomized, double-blind, placebo-controlled trials involving adults who had moderate-to-severe atopic dermatitis despite treatment with topical glucocorticoids and calcineurin inhibitors...
July 10, 2014: New England Journal of Medicine
Jin-Han Kang
Influenza causes acute respiratory infections and various complications. Children in the high-risk group have higher complication and hospitalization rates than high-risk elderly individuals. Influenza prevention in children is important, as they can be a source infection spread in their communities. Influenza vaccination is strongly recommended for high-risk children with chronic underlying circulatory and respiratory disease, immature infants, and children receiving long-term immunosuppressant treatment or aspirin...
April 2014: Korean Journal of Pediatrics
P Solidoro, F Braido, M Boffini, A G Corsico
This article is an attempt to analyze and discuss the role and the purported mechanisms of azithromycin (AZM) in non-eosinophilic severe asthma, including antineutrophil activity, an effect on gastroesophageal reflux or antibacterial activity against an underlying chronic infection, such as Chlamydia pneumoniae. Macrolides have an expanding role in the therapy of chronic inflammatory diseases based on their additional anti-inflammatory and immunosuppressive properties. Many studies have been performed in lung transplantation field and maintenance treatment has been proved to be effective in cystic fibrosis, bronchiectasis, diffuse panbronchiolitis, and in bronchiolitis obliterans syndrome and in the prevention of exacerbations in patients with chronic obstructive pulmonary disease...
December 2013: Minerva Medica
William W Busse, Stephen Holgate, Edward Kerwin, Yun Chon, Jingyuan Feng, Joseph Lin, Shao-Lee Lin
RATIONALE: IL-17 signaling has been implicated in development and persistence of asthma. Cytokine-targeted strategies blocking IL-17 receptor signaling may be beneficial in asthma treatment. OBJECTIVES: To determine efficacy and safety of brodalumab, a human anti-IL-17 receptor A monoclonal antibody, in subjects with inadequately controlled moderate to severe asthma taking regular inhaled corticosteroids. METHODS: Three hundred two subjects were randomized to brodalumab (140, 210, or 280 mg) or placebo...
December 1, 2013: American Journal of Respiratory and Critical Care Medicine
Yoshihisa Miyamoto, Koui Ka
Fever and upper respiratory tract infections (URI) are frequently-encountered preoperative comorbidities. Whether or not to proceed with anesthesia for a child with common cold is still a continuing dilemma for anesthesiologists. We, anesthesiologists often feel uncomfortable in making a decision whether or not to proceed because URI is associated with perioperative respiratory adverse events (PRAEs) and there are no definite rules to proceed with or postpone a case. Most of PRAEs are easily managed by experienced hands; however, laryngospasm or bronchospasm without early detection and immediate treatment would probably result in serious sequelae...
September 2013: Masui. the Japanese Journal of Anesthesiology
Chad K Oh, Richard Leigh, Kimmie K McLaurin, Keunpyo Kim, Micki Hultquist, Nestor A Molfino
BACKGROUND: Preclinical studies suggest that interleukin-9 may be a central mediator in the development and maintenance of airway inflammation in asthma. The aim of this study was therefore to evaluate the effects of MEDI-528, an anti-interleukin-9 monoclonal antibody, in adults with confirmed uncontrolled moderate-to-severe asthma. METHODS: In this prospective double-blind, multicenter, parallel-group study, 329 subjects were randomized (1:1:1:1) to subcutaneous placebo or MEDI-528 (30, 100, 300 mg) every 2 weeks for 24 weeks, in addition to their usual asthma medications...
2013: Respiratory Research
Laura Somerville, Jose Bardelas, Andrea Viegas, Peter D'Andrea, Martin Blogg, Guy Peachey
BACKGROUND: Omalizumab, a humanised anti-immunoglobulin E monoclonal antibody for treatment of uncontrolled moderate-to-severe or severe persistent allergic asthma, was developed as a lyophilised powder for reconstitution. A liquid formulation in pre-filled syringes has now been developed. The purpose of this study was to assess the immunogenicity and safety of this liquid formulation. METHODS: In this multinational, open-label, single-arm study, patients (≥12 years) with moderate-to-severe allergic asthma were treated for 24 weeks with the liquid formulation of omalizumab (75 or 150 mg in a pre-filled syringe) at 2 or 4 week intervals...
January 2014: Current Medical Research and Opinion
William W Busse, Sally E Wenzel, Eli O Meltzer, Edward M Kerwin, Mark C Liu, Nan Zhang, Yun Chon, Alison L Budelsky, Joseph Lin, Shao-Lee Lin
BACKGROUND: The D-prostanoid receptor and the chemoattractant receptor homologous molecule expressed on T(H)2 cells (CRTH2) are implicated in asthma pathogenesis. AMG 853 is a potent, selective, orally bioavailable, small-molecule dual antagonist of human D-prostanoid and CRTH2. OBJECTIVE: We sought to determine the efficacy and safety of AMG 853 compared with placebo in patients with inadequately controlled asthma. METHODS: Adults with moderate-to-severe asthma were randomized to placebo; 5, 25, or 100 mg of oral AMG 853 twice daily; or 200 mg of AMG 853 once daily for 12 weeks...
February 2013: Journal of Allergy and Clinical Immunology
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