The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results
Authors Ambrose CS, Chipps BE, Moore WC, Soong W, Trevor J, Ledford DK, Carr WW, Lugogo N, Trudo F, Tran TN, Panettieri RA Jr
Received 26 February 2020
Accepted for publication 31 May 2020
Published 16 July 2020 Volume 2020:11 Pages 77—90
Checked for plagiarism Yes
Review by Single-blind
Peer reviewer comments 2
Editor who approved publication: Professor David Price
Christopher S Ambrose,1 Bradley E Chipps,2 Wendy C Moore,3 Weily Soong,4 Jennifer Trevor,5 Dennis K Ledford,6 Warner W Carr,7 Njira Lugogo,8 Frank Trudo,9 Trung N Tran,10 Reynold A Panettieri Jr11
1US Medical Affairs, AstraZeneca, Gaithersburg, MD, USA; 2Capital Allergy & Respiratory Disease Center, Sacramento, CA, USA; 3Pulmonary, Critical Care, Allergy, and Immunologic Medicine, Wake Forest School of Medicine, Winston-Salem, NC, USA; 4Alabama Allergy & Asthma Center, Birmingham, AL, USA; 5Pulmonary, Allergy, & Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; 6Division of Allergy and Immunology, University of South Florida, Tampa, FL, USA; 7Allergy & Asthma Associates of Southern California, Mission Viejo, CA, USA; 8Pulmonary & Critical Care Medicine, University of Michigan, Ann Arbor, MI, USA; 9US Medical Affairs, AstraZeneca, Wilmington, DE, USA; 10Biopharmaceuticals Medical, Respiratory and Immunology, AstraZeneca, Gaithersburg, MD, USA; 11Institute for Translational Medicine and Science, Rutgers, The State University of New Jersey, New Brunswick, NJ, USA
Correspondence: Christopher S Ambrose Tel +1 (301) 398-4454
Fax +1 301-398-9454
Background: Approximately 5– 10% of patients with asthma have severe disease. High-quality real-world studies are needed to identify areas for improved management.
Objective: Aligned with the International Severe Asthma Registry, the CHRONICLE study (ClinicalTrials.gov: NCT03373045) was developed to address this need in the US.
Study Design: Learnings from prior studies were applied to develop a real-world, prospective, noninterventional study of US patients with confirmed severe asthma who are treated by subspecialist physicians and require biologic or maintenance systemic immunosuppressant therapy or who are uncontrolled by high-dosage inhaled corticosteroids and additional controllers. Target enrollment is 4000 patients, with patient observation for ≥ 3 years. A geographically diverse sample of allergist/immunologist and pulmonologist sites approach all eligible patients under their care and report patient characteristics, treatment, and health outcomes every 6 months. Patients complete online surveys every 1– 6 months.
Initial Results: From February 2018 to February 2019, 102 sites screened 1428 eligible patients; 936 patients enrolled. Study sites (40% allergist/immunologist, 42% pulmonologist, 18% both) were similar to other US asthma subspecialist samples. Enrolled patients were 67% female with median ages at enrollment and diagnosis of 55 (range: 18– 89) and 26 (0– 80) years, respectively. Median body mass index was 31 kg/m2; 3% and 29% were current or former smokers, respectively, and > 60% reported ≥ 1 exacerbation in the prior year and suboptimal symptom control.
Conclusion: CHRONICLE will provide high-quality provider- and patient-reported data from a large, real-world cohort of US adults with subspecialist-treated severe asthma.
Keywords: asthma exacerbations, longitudinal studies, allergists, pulmonologists, biologic therapy
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