The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results.

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/m ² ; 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.
Competing Interests: Christopher S. Ambrose, Frank Trudo, and Trung N. Tran are employees of AstraZeneca. Bradley E. Chipps is an advisor for, received consultancy fees from, and is on the speakers’ bureau for AstraZeneca, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Novartis, Regeneron, and Sanofi Genzyme. Wendy C. Moore is on advisory boards for and reports grant and personal fees from AstraZeneca, Sanofi Regeneron, Genentech, and GlaxoSmithKline. She is also a member of the writing and steering committee for the CHRONICLE study as well as a PI of the clinical trial at Wake Forest. Weily Soong is a consultant for and reports grants from AstraZeneca, Genentech, GlaxoSmithKline, Mandala, Novartis, Regeneron, Sanofi, and Teva; and is a speaker for AstraZeneca, GlaxoSmithKline, Regeneron, Sanofi, and Optinose. Jennifer Trevor is a consultant for AstraZeneca; and is on advisory boards for AstraZeneca, GlaxoSmithKline, and Boehringer Ingelheim. Dennis K. Ledford reports research support (paid to University) from Genentech/Roche, Novartis, and AstraZeneca. He reports royalties from Wolters Kluwer Health and Taylor and Francis. He is an Editor for the American Academy of Allergy, Asthma & Immunology (AAAAI). He is also a consultant/speaker for and reports personal fees from ALK, AstraZeneca, Boehringer Ingelheim, Genentech/Roche, GlaxoSmithKline, Meda, Novartis, Sanofi/Regeneron, and Teva, and fees received for legal opinions on drug allergy, metal allergy, radiocontrast reaction, and asthma death. Warner W. Carr is a speaker for AstraZeneca, Teva, Boehringer Ingelheim, Regeneron, and Sanofi; and a consultant for AstraZeneca, Teva, Boehringer Ingelheim, Regeneron, Sanofi, Circassia, CSL Behring, Genentech, GlaxoSmithKline, Horizon Pharma, Kaleo, Mylan, Pfizer, Shire, Meda, Baxalta, Novartis, Greer Laboratories, Alcon Laboratories, Valeant Pharmaceuticals, Grifols, Optinose, and Aerocrine. Njira Lugogo is on advisory boards for AstraZeneca, Sanofi, Genentech, Novartis, Teva, and GlaxoSmithKline. She also reports clinical trial funding to her institution from AstraZeneca, GlaxoSmithKline, and Sanofi. Reynold A. Panettieri Jr is on advisory boards for and reports grant support/personal fees from AstraZeneca, Sanofi, Genentech, Regeneron, MedImmune, RIFM, Equillium, Theravance, Avillion, OncoArendi, Meresa, NIH, and Novartis. The authors report no other conflicts of interest in this work.
(© 2020 Ambrose et al.)