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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...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7371434/ https://www.ncbi.nlm.nih.gov/pubmed/32765156 http://dx.doi.org/10.2147/POR.S251120 |
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author | Ambrose, Christopher S Chipps, Bradley E Moore, Wendy C Soong, Weily Trevor, Jennifer Ledford, Dennis K Carr, Warner W Lugogo, Njira Trudo, Frank Tran, Trung N Panettieri, Reynold A |
author_facet | Ambrose, Christopher S Chipps, Bradley E Moore, Wendy C Soong, Weily Trevor, Jennifer Ledford, Dennis K Carr, Warner W Lugogo, Njira Trudo, Frank Tran, Trung N Panettieri, Reynold A |
author_sort | Ambrose, Christopher S |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7371434 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-73714342020-08-05 The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results Ambrose, Christopher S Chipps, Bradley E Moore, Wendy C Soong, Weily Trevor, Jennifer Ledford, Dennis K Carr, Warner W Lugogo, Njira Trudo, Frank Tran, Trung N Panettieri, Reynold A Pragmat Obs Res Study Protocol 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. Dove 2020-07-16 /pmc/articles/PMC7371434/ /pubmed/32765156 http://dx.doi.org/10.2147/POR.S251120 Text en © 2020 Ambrose et al. http://creativecommons.org/licenses/by-nc/3.0/ This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Study Protocol Ambrose, Christopher S Chipps, Bradley E Moore, Wendy C Soong, Weily Trevor, Jennifer Ledford, Dennis K Carr, Warner W Lugogo, Njira Trudo, Frank Tran, Trung N Panettieri, Reynold A The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results |
title | The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results |
title_full | The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results |
title_fullStr | The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results |
title_full_unstemmed | The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results |
title_short | The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results |
title_sort | chronicle study of us adults with subspecialist-treated severe asthma: objectives, design, and initial results |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7371434/ https://www.ncbi.nlm.nih.gov/pubmed/32765156 http://dx.doi.org/10.2147/POR.S251120 |
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