Prospective, Single-Arm, Longitudinal Study of Biomarkers in Real-World Patients with Severe Asthma.

ARIETTA was a prospective, single-arm, noninterventional, multicenter study in patients with severe asthma.To examine the predictive and prognostic abilities of type 2 biomarkers for severe asthma outcomes.Adult patients with severe asthma receiving daily inhaled corticosteroids (fluticasone propionate ≥500 μg or equivalent) and ≥1 second controller medication were enrolled. Biomarker, clinical, and safety data were collected over 52 weeks. The primary endpoint was the asthma exacerbation rate over 52 weeks in serum periostin-high (≥50 ng/mL at baseline) versus periostin-low subgroups (50 ng/mL). Correlations between biomarker levels (periostin, blood eosinophils, IgE, and fractional exhale…

Comparing asthma treatment in elderly versus younger patients

SummaryA randomised 6-month study compared two maintenance doses of budesonide/formoterol (Symbicort® Turbuhaler®)hhNeither the Symbicort SMART posology nor the dry powder formulation, Turbuhaler, is currently approved in the US. maintenance and reliever therapy (Symbicort SMART®), 160/4.5 μg 1 × 2 and 2 × 2, in 8053 asthmatics with symptoms despite treatment with inhaled corticosteroids ± inhaled long-acting β2-agonists. This analysis compared response to the two treatments in elderly patients, ≥65 years, with that in younger patients. Elderly patients with early- or late-onset asthma were also compared.Elderly patients had lower post-bronchodilator FEV1 percentage predicted normal at base…

Budesonide/Formoterol Maintenance And Reliever Therapy At Two Different Maintenance Doses

Budesonide/Formoterol Maintenance And Reliever Therapy At Two Different Maintenance Doses: Effect On Fractional Excretion Of Nitric Oxide (FENO)

The Arietta Study: Exploring Severe Asthma Biomarkers in a Real-World Setting

The ARIETTA study: baseline demographics in a real-world setting in patients with severe asthma

Introduction and Aim: As recognition of asthma heterogeneity increases and targeted treatment options are introduced, the future role of biomarkers (BM) in patient (pt) selection, monitoring and risk prediction will be important. We report baseline demographic and clinical characteristics from ARIETTA, an ongoing, prospective, longitudinal study assessing the relationship between BM and disease-related health outcomes in the real world. Methods: Pts with severe asthma (GINA steps 4-5) receiving daily inhaled corticosteroids (CS; fluticasone propionate ≥500 μg or equivalent) and ≥1 second controller medication were enrolled. Study enrollment is now complete. BM, clinical characteristics and …

Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen?

Objective: Baseline inhaled corticosteroid (ICS) dose may be a factor for prescribers to consider when they select a budesonide/formoterol maintenance and reliever therapy regimen for symptomatic asthmatics. Methods: A 6-month randomized study compared two maintenance doses of budesonide/formoterol 160/4.5 µg, 1 × 2 and 2 × 2, plus as needed, in 8424 asthma patients with symptoms when treated with ICS ± an inhaled long-acting β2-agonist (LABA). In the total study population, 1339 (17%) were high-dose ICS (HD) users (≥1600 µg/day budesonide). This HD stratum was compared with the rest of the study population, divided into low-dose (LD; 400 µg/day) and medium-dose strata (MD; 401–1599 µg/day…

Budesonide/Formoterol Maintenance And Reliever Therapy In Patients With Difficult-To-Control Asthma

Do asthmatic smokers benefit as much as non-smokers on budesonide/formoterol maintenance and reliever therapy? Results of an open label study

SummaryBackgroundStudies with inhaled corticosteroids (ICS) in smoking asthmatics have mostly shown poorer treatment responses than in non-smoking asthmatics.MethodsEuroSMART, an open, randomised, 6-month study, compared budesonide/formoterol (Symbicort ® Turbuhaler®)hhNeither the Symbicort SMART posology nor the dry powder formulation, Turbuhaler, is currently approved in the US. maintenance and reliever therapy (Symbicort SMART®) at two maintenance doses of budesonide/formoterol (160/4.5 μg), 1 × 2 and 2 × 2, in patients with asthma who were symptomatic despite treatment with ICS ± long-acting β2-agonists. The 8424 randomised patients included 886 smokers (11%; aged <40 years or with a sm…

Assessing biomarkers in a real-world severe asthma study (ARIETTA)

AbstractThe prognostic value of asthma biomarkers in routine clinical practice is not fully understood. ARIETTA (NCT02537691) is an ongoing, prospective, longitudinal, international, multicentre real-world study designed to assess the relationship between asthma biomarkers and disease-related health outcomes. The trial aims to enrol and follow for 52 weeks approximately 1200 severe asthma patients from approximately 160 sites in more than 20 countries. Severe asthmatics, treated with daily inhaled corticosteroid (≥500 μg of fluticasone propionate or equivalent) and at least 1 second controller medication are to be included. In this real-world study, patients will be treated according to the…