0000000000674344
AUTHOR
Hanne H. Villesen
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…
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…