0000000000344864
AUTHOR
Vibeke Backer
Development of the International Severe Asthma Registry (ISAR): A Modified Delphi Study
BACKGROUND: The lack of centralised data on severe asthma has resulted in a scarcity of information about the disease and its management. The development of a common data collection tool for the International Severe Asthma Registry (ISAR) will enable standardised data collection, subsequently enabling data interoperability.OBJECTIVES: To create a standardised list of variables for the first international registry for severe asthma via expert consensus.METHODS: A modified Delphi process was used to reach consensus on a minimum set of variables to capture in ISAR: the core variables. The Delphi panel brought together 27 international experts in the field of severe asthma research. The process…
Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement
Background Exacerbations are a key outcome in clinical research, providing patient-relevant information about symptomatic control, health state and disease progression. Generally considered as an episode of (sub)acute deterioration of respiratory symptoms, a precise, clinically useful definition is needed for use in clinical trials. Aim and methods Focussing on moderate exacerbations, this opinion piece reviews landmark trials and current guidelines to provide a practical definition of a moderate exacerbation. Specifically, we adapt the ATS/ERS consensus statement of terminology Reddel et al. (2009) [1] which provides a conceptual (or 'theoretical') definition for moderate exacerbations, to…
Eosinophilic and Noneosinophilic Asthma
Background Phenotypic characteristics of patients with eosinophilic and noneosinophilic asthma are not well characterized in global, real-life severe asthma cohorts. Research Question What is the prevalence of eosinophilic and noneosinophilic phenotypes in the population with severe asthma, and can these phenotypes be differentiated by clinical and biomarker variables? Study Design and Methods This was an historical registry study. Adult patients with severe asthma and available blood eosinophil count (BEC) from 11 countries enrolled in the International Severe Asthma Registry (January 1, 2015-September 30, 2019) were categorized according to likelihood of eosinophilic phenotype using a pre…
Le comprimé d’immunothérapie sublinguale acariens SQ est efficace dans le traitement de l’asthme allergique ; résultats de l’essai de phase III MITRA
Introduction Les allergenes d’acariens domestiques sont associes a une pathologie respiratoire persistante. La rhinite allergique et l’asthme allergique (AA) coexistent frequemment. L’immunotherapie a le potentiel de modifier la cause de la maladie sous-jacente. Nous rapportons ici l’efficacite du comprime acarien d’immunotherapie sublinguale (ITSL) SQ-HDM (ALK, Danemark) sur le controle de l’asthme allergique aux acariens (AAA). Methodes L’essai europeen randomise en double aveugle controle par placebo MITRA (EudraCT 2010-018621-19) a inclus 834 sujets de 13 pays, ayant a l’inclusion un asthme allergique depuis plus d’un an, des tests de sensibilisation aux acariens positifs et un asthme m…
Efficacy of a House Dust Mite Sublingual Allergen Immunotherapy Tablet in Adults With Allergic Asthma: A Randomized Clinical Trial.
Importance The house dust mite (HDM) sublingual allergen immunotherapy (SLIT) tablet is a potential novel treatment option for HDM allergy–related asthma. Objectives To evaluate the efficacy and adverse events of the HDM SLIT tablet vs placebo for asthma exacerbations during an inhaled corticosteroid (ICS) reduction period. Design, Settings, and Participants Double-blind, randomized, placebo-controlled trial conducted between August 2011 and April 2013 in 109 European trial sites. The trial included 834 adults with HDM allergy–related asthma not well controlled by ICS or combination products, and with HDM allergy–related rhinitis. Key exclusion criteria were FEV 1 less than 70% of predicted…