title: Assessing biomarkers in a real-world severe asthma study (ARIETTA).
abstract: The 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 investigator's routine clinical practices and no treatment regimen will be implemented as part of the trial. At baseline and again at 26 and 52 weeks, FEV1, FeNO, serum periostin, blood eosinophil count and serum IgE will be measured. Asthma-related symptom and quality of life questionnaires will be administered at the visits and during telephone interviews at Weeks 13 and 39. Data about medication use, asthma exacerbation data, asthma-related healthcare utilization and events raising safety concerns will also be collected. This study design, unique in both its scope and scale, will address fundamental unanswered questions regarding asthma biomarkers and their interrelationship, as well as predict deviations in the course of asthma in a real-world setting.
authors.affiliation: Pulmonary Department, University Hospital, Johannes Gutenberg-University, Langenbeckstr. 1, D-55131 Mainz, Germany. Electronic address: roland.buhl@unimedizin-mainz.de.
authors.forename: Roland
authors.initials: R
authors.lastname: Buhl
authors.affiliation: Pulmonary Department, University Hospital, Johannes Gutenberg-University, Langenbeckstr. 1, D-55131 Mainz, Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Korn
authors.affiliation: Royal Brompton Hospital, London, United Kingdom.
authors.forename: Andrew
authors.initials: A
authors.lastname: Menzies-Gow
authors.affiliation: Service de Pneumologie A, Hôpital Bichat, Inserm U1152, Université Paris Diderot, Paris, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Aubier
authors.affiliation: Asthma & Airway Centre, University Health Network and University of Toronto, Toronto, Canada.
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Chapman
authors.affiliation: Allergy and Respiratory Diseases, Department of Internal Medicine, University of Genoa, Largo Rosanna Benzi 10, Genoa 16132, Italy.
authors.forename: Giorgio W
authors.initials: GW
authors.lastname: Canonica
authors.affiliation: Hospital Clínic de Barcelona, Institut de Pneumologia, CIBERES, University of Barcelona, Barcelona, Spain.
authors.forename: César
authors.initials: C
authors.lastname: Picado
authors.affiliation: F. Hoffmann-La Roche Ltd, Grenzacherstrasse, Basel, Switzerland.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Martin
authors.affiliation: F. Hoffmann-La Roche Ltd, Grenzacherstrasse, Basel, Switzerland.
authors.forename: Ramon Aguiar
authors.initials: RA
authors.lastname: Escobar
authors.affiliation: F. Hoffmann-La Roche Ltd, Grenzacherstrasse, Basel, Switzerland.
authors.forename: Stephan
authors.initials: S
authors.lastname: Korom
authors.affiliation: Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston, Texas, United States.
authors.forename: Nicola A
authors.initials: NA
authors.lastname: Hanania
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use; D000328:Adult; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy / Q000378:metabolism*; D015415:Biomarkers / Q000097:blood*; D015815:Cell Adhesion Molecules / Q000097:blood; D004804:Eosinophils / Q000276:immunology; D005260:Female; D000068298:Fluticasone / Q000008:administration & dosage / Q000627:therapeutic use; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D008297:Male; D009569:Nitric Oxide / Q000097:blood; D011237:Predictive Value of Tests; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D012720:Severity of Illness Index
chemical_list: D000305:Adrenal Cortex Hormones; D015415:Biomarkers; D015815:Cell Adhesion Molecules; C512835:POSTN protein, human; D009569:Nitric Oxide; D007073:Immunoglobulin E; D000068298:Fluticasone
keywords: Biomarker; Eosinophil; Exacerbation; Periostin; Severe asthma