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In this article, we discuss the importance of real-world data in the treatment of patients with asthma and specifically the role of maintenance and reliever therapy (MART) with beclometasone dipropionate (BDP)/formoterol fumarate dihydrate (FF) delivered through a dry-powder inhaler (DPI) that contains an extrafine formulation. We also present the design of the NEWTON study. This multinational, multicenter, prospective, observational study will evaluate the real-world use of extrafine BDP/FF via a DPI as maintenance therapy and MART in patients with moderate to severe asthma. The study's primary outcome will be the proportion of patients improving their asthma control. Digitally collected patient-reported outcomes, such as the 5-item Asthma Control Questionnaire, the EuroQol 5-dimension 5-level, and the Test of the Adherence to Inhalers, will be used to assess the patient's asthma control, quality of life, and treatment adherence. Moreover, a new patient-reported outcome, the "Speed of change in health feeling" questionnaire, will be validated in a subgroup of patients. Overall, the results of this study will provide a real-life assessment of patients who perceived clinical benefits in a large cohort of asthmatics in Europe treated as per current clinical practice. [ABSTRACT FROM AUTHOR]

The quality of life (QoL) and device needs have not been characterized in asthmatic patients treated via dry powder inhalers (DPIs). The aim of this study was to assess the impact of asthma on health-related QoL, device satisfaction, and preference in adult asthmatic patients using DPI devices, and to identify any DPI-associated unmet needs. An online survey was conducted between November and December 2019 on eligible patients from the Cint consumer panel across Europe. Newly designed, as well as validated questionnaires were used to collect data on QoL and inhaler satisfaction. A total of 1063 asthmatic patient took part in the survey; 66% of the patients reported medium or high impact of asthma on the overall QoL. The majority of patients (61%) reported high level of satisfaction with their current device. The patients with medium-to-high impact of asthma on QoL were significantly less likely to be satisfied with their current device (55%) than those who reported low-to-medium impact of asthma on QoL (67%; p-value < 0.001). "Higher number of available doses," "usability," "clear dose counter," and "feedback on correct inhalation" were the attributes mostly requested from a new device. The demand for user-friendly devices that provide feedback on correct drug administration was identified as an unmet need. In asthmatic patients with medium to high impact of asthma on the overall QoL, the satisfaction with the device is highly affected. [ABSTRACT FROM AUTHOR]

Background: According to the Global Initiative of Asthma, the aim of asthma treatment is to gain and maintain control. In the INTERNATIONAL CROSS-SECTIONAL AND LONGITUDINAL ASSESSMENT ON ASTHMA CONTROL (LIAISON) study, we evaluated the level of asthma control and quality of life (QoL), as well as their determinants and impact in a population consulting specialist settings.Methods: LIAISON is a prospective, multicentre, observational study with a cross-sectional and a 12-month longitudinal phase. Adults with an asthma diagnosis since at least 6 months, receiving the same asthma treatment in the 4 weeks before enrolment were included. Asthma control was assessed with the 6-item Asthma Control Questionnaire (ACQ) and QoL with the MiniAsthma Quality of Life Questionnaire (MiniAQLQ).Results: Overall, 8111 asthmatic patients were enrolled in 12 European countries. Asthma control was suboptimal in 56.5 % of patients and it was associated with poorer asthma-related QoL, higher risk of exacerbations and greater consumption of healthcare resources. Variables associated with suboptimal control were age, gender, obesity, smoking and comorbidities. Major determinants of poor asthma control were seasonal worsening and persisting exposure to allergens/irritants/triggers, followed by treatment-related issues.Conclusions: The cross-sectional phase results confirm that suboptimal control is frequent and has a high individual and economic impact.Trial Registration: The clinicaltrials.gov identifier is NCT01567280 . [ABSTRACT FROM AUTHOR]

Prescription cost-containment measures are increasing in many European countries and, as more inhaler devices become available, there may be pressure to switch patients from reference inhaled medication to cheaper generic inhaled drugs. Indeed, in some countries, such a substitution is mandated by current regulations, and patients who do not accept the substitution have to pay the difference in cost. Generic inhaled drugs are therapeutically equivalent to original branded options but may differ in their formulation and inhalation device. This new situation raises questions about the potential impact of switching from branded to generic inhaled medications in patients with asthma or chronic obstructive pulmonary disease (COPD), with or without their consent, in countries where this is permitted. Acquisition cost savings from a substitution could be offset by costs related to deterioration in asthma control or worsening in COPD outcomes if the patient is unable or unwilling to use the inhaler device properly. Non-adherence to therapy and incorrect inhaler usage are recognised as major factors in uncontrolled asthma and worsening of COPD outcomes. Switching patients to a different inhaler device may exacerbate these problems, particularly in patients who disagree to switch. Where switching is permitted or mandatory, it is crucial that the reason for switching has been properly explained to the patient and adequate instruction for operating correctly the inhaler have clearly been provided. [ABSTRACT FROM AUTHOR]

Smart devices and Internet-based applications (apps) are largely used in allergic rhinitis and may help to address some unmet needs. However, these new tools need to first of all be tested for privacy rules, acceptability, usability, and cost-effectiveness. Second, they should be evaluated in the frame of the digital transformation of health, their impact on health care delivery, and health outcomes. This review (1) summarizes some existing mobile health apps for allergic rhinitis and reviews those in which testing has been published, (2) discusses apps that include risk factors of allergic rhinitis, (3) examines the impact of mobile health apps in phenotype discovery, (4) provides real-world evidence for care pathways, and finally (5) discusses mobile health tools enabling the digital transformation of health and care, empowering citizens, and building a healthier society., (Copyright © 2019 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.)

Background: According to international guidelines, the goal of asthma management is to achieve and maintain control of the disease, which can be assessed using composite measures. Prospective studies are required to determine how these measures are associated with asthma outcomes and/or future risk. The 'InternationaL cross-sectIonAl and longItudinal assessment on aSthma cONtrol (LIAISON)' observational study has been designed to evaluate asthma control and its determinants, including components of asthma management., Methods/design: The LIAISON study will be conducted in 12 European countries and comprises a cross-sectional phase and a 12-month prospective phase. Both phases will aim at assessing asthma control (six-item Asthma Control Questionnaire, ACQ), asthma-related quality of life (Mini Asthma Quality of Life Questionnaire, Mini-AQLQ), risk of non-adherence to treatment (four-item Morisky Medication Adherence Scale, MMAS-4), potential reasons for poor control, treatment strategies and associated healthcare costs.The cross-sectional phase will recruit > 8,000 adult patients diagnosed with asthma for at least 6 months and receiving the same asthma treatment in the 4 weeks before enrolment.The prospective phase will include all patients with uncontrolled/poorly controlled asthma at the initial visit to assess the proportion reaching control during follow-up and to examine predictors of future risk. Visits will take place after 3, 6 and 12 months., Discussion: The LIAISON study will provide important information on the prevalence of asthma control and on the quality of life in a broad spectrum of real-life patient populations from different European countries and will also contribute to evaluate differences in management strategies and their impact on healthcare costs over 12 months of observation., Trial Registration: ClinicalTrials.gov identifier, NCT01567280.

Purpose: Despite the high and increasing prevalence of allergic diseases in athletes, allergy diagnostics is not part of the routine medical examination in sports medicine. This study reports the development and validation of an easy and reliable questionnaire for screening allergy in athletes., Methods: AQUA was derived from the European Community Respiratory Health Survey Questionnaire. On the basis of open interviews with team doctors, coaches, and athletes, questions were added about: the type, duration, and intensity of training; exercise-related allergic and infectious symptoms; social habits (smoking); drug and food supplements intake; antidoping regulations. The final version of the questionnaire, made of 25 selected questions, was validated in 128 professional soccer players who underwent accurate history taking, medical examination, skin prick testing, and/or specific IgE determination. On the basis of the correlation with objective allergy (positive skin tests to at least one allergen), questions were scored from 1 to 5 according to their positive likelihood ratio., Results: Skin tests (gold standard for validation) were positive in 46.8% of soccer players. Mean total AQUA score was 9.4 +/- 7.8 in allergic athletes versus 1.3 +/- 2.3 in nonallergic athletes. A total AQUA score of >or=5 was shown to have the best positive predictive value for allergy (0.94) with a specificity of 97.1% and a sensitivity of 58.3%., Conclusions: AQUA, produced in 10 European languages, is a validated, easy, and reliable tool for calling attention on the high prevalence of allergy in athletes.