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- W2340600969 abstract "As the heterogeneity of asthma is increasingly recognized, and targeted treatment options emerge, the role of asthma biomarkers in patient selection, monitoring and risk-prediction will be important. However, the prognostic value of these biomarkers in a real-world clinical setting remains unknown. Here, we outline the design of a multicenter, prospective, longitudinal non-interventional study that aims to assess the relationship between biomarkers and asthma-related health outcomes in a real-world setting. The study will enroll ∼1200 adult patients with severe asthma (GINA steps 4–5) from ∼160 sites in 21 countries, who will have regular follow-ups over 52 weeks (NCT02537691). Enrollment criteria include adults with asthma requiring daily inhaled corticosteroid (≥500 μg fluticasone propionate or equivalent) and ≥1 second controller. Key biomarkers assessed include FeNO, serum periostin, blood eosinophil count and serum IgE. Data on pulmonary function, symptoms and quality of life, exacerbations, asthma-related healthcare utilization and safety events will also be collected. During the study, patients’ treatment regimens are not pre-specified. The primary outcome is the rate of asthma exacerbations from baseline to Week 52 in patients with high periostin levels (≥50 ng/mL) compared with those with low levels (<50 ng/mL). Secondary analyses will examine the longitudinal relationship between different asthma biomarkers and clinical outcomes. The first patient was enrolled in August 2015. Data is expected to be available in 2018. This unique real-world study will address crucial unanswered questions regarding asthma biomarkers, their prognostic value, and ultimately help guide clinicians to a more targeted therapeutic approach to severe asthma." @default.
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- W2340600969 date "2016-02-01" @default.
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- W2340600969 title "The Arietta Study: Exploring Severe Asthma Biomarkers in a Real-World Setting" @default.
- W2340600969 doi "https://doi.org/10.1016/j.jaci.2015.12.924" @default.
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