ALAT Severe Asthma Registry Protocol: the REAL Registry
Article Sidebar
Main Article Content
Abstract
Introduction: Severe asthma (SA) affects 5-15% of asthmatic patients, carrying a high clinical and economic burden. Heterogeneity exists in its presentation and management, with limited information in Latin America. The ALAT's Latin American Severe Asthma Registry (REAL) was designed to characterize this population in the region.
Primary objective: To describe the natural history and the clinical, functional, phenotypic, and therapeutic characteristics of patients with SA in Latin America.
Methods: Observational, prospective, multicenter study in specialized centers across Latin America. Patients ≥ 18 years old diagnosed with SA according to ALAT/ERS/ATS criteria, providing informed consent, were included. Three visits (baseline, 6, and 12 months) recorded demographic, clinical (symptom control via ACT, exacerbations, systemic corticosteroids, hospitalizations), functional (spirometry), biomarker (eosinophils, IgE, prick test, FeNO if available), comorbidity, treatment (including biologics), and adherence (TAI) variables. Data will be managed using REDCap. Descriptive and comparative analyses will be performed; prognostic factors will be explored using regression models.
Ethical Considerations: The protocol requires approval from each participating center's Ethics Committee. Written informed consent will be obtained. Data confidentiality will be ensured.
Discussion/Expected Outcomes: The REAL Registry will generate specific information on SA in Latin America, allowing the identification of prevalent phenotypes and the evaluation of real-world treatment patterns (to assess the response in the subgroup of patients treated with biologics) and clinical outcomes. This will contribute to optimizing management, guiding public health strategies and fostering research adapted to the region.
Downloads
Article Details
Section
This work is licensed under a Creative Commons Attribution 4.0 International License.
How to Cite
References
Chung K, Wenzel S, Brozek J et al. International ERS/ATS Guidelines on Definition, Evaluation, and Treatment of Severe Asthma. Eur Resp J 2013:1–112. https://doi.org/https://doi.org/10.1183/09031936.00202013
García G, Bergna M, Vásquez JC et al. Severe asthma: adding new evidence - Latin American Thoracic Society. ERJ Open Res 2021;7:00318–2020. https://doi.org/10.1183/23120541.00318-2020
Hekking PPW, Wener RR, Amelink M, Zwinderman AH, Bouvy ML, Bel EH. The prevalence of severe refractory asthma. J Allergy Clin Immunol 2015;135:896–902. https://doi.org/10.1016/J.JACI.2014.08.042
Zabert I, Stok A, Cano C et al. Clinical Practice Guideline of Severe Asthma, ALAT 2024. Respirar 2025;17:7–30. https://doi.org/10.55720/respirar.17.1.1
Shaw DE, Sousa AR, Fowler SJ et al. Clinical and inflammatory characteristics of the European U-BIOPRED adult severe asthma cohort. Eur Resp J 2015;46:1308–21. https://doi.org/10.1183/13993003.00779-2015
Heaney LG, Perez de Llano L, Al-Ahmad M et al. Eosinophilic and Noneosinophilic Asthma: An Expert Consensus Framework to Characterize Phenotypes in a Global Real-Life Severe Asthma Cohort. Chest 2021;160:814–30. https://doi.org/10.1016/J.CHEST.2021.04.013
Brusselle GG, Koppelman GH. Biologic Therapies for Severe Asthma. N Eng J Med 2022;386:157–71. https://doi.org/10.1056/NEJMra2032506
Wang E, Wechsler ME, Tran TN et al. Characterization of Severe Asthma Worldwide: Data From the International Severe Asthma Registry. Chest 2020;157:790–804. https://doi.org/10.1016/j.chest.2019.10.053
Caminati M, Senna G. Uncontrolled severe asthma: starting from the unmet needs. Curr Med Res Opin 2019;35:175–7. https://doi.org/10.1080/03007995.2018.1528218
García G, Bergna M, Vásquez JC et al. Severe asthma: adding new evidence - Latin American Thoracic Society. ERJ Open Res 2021;7:00318–2020. https://doi.org/10.1183/23120541.00318-2020
Peters SP, Ferguson G, Deniz Y, Reisner C. Uncontrolled asthma: a review of the prevalence, disease burden and options for treatment. Respir Med 2006;100:1139–51. https://doi.org/10.1016/J.RMED.2006.03.031
McDonald VM, Harrington J, Clark VL, Gibson PG. Multidisciplinary care in chronic airway diseases: the Newcastle model. ERJ Open Res 2022;8. https://doi.org/10.1183/23120541.00215-2022
McDonald VM, Gibson PG. Treatable Traits in Asthma and COPD. Arch Bronconeumol 2022;58:583–5. https://doi.org/10.1016/J.ARBRES.2021.07.003
Agusti A, Bel E, Thomas M et al. Treatable traits: toward precision medicine of chronic airway diseases. Eur Respir J 2016;47:410–9. https://doi.org/10.1183/13993003.01359-2015
Chipps BE, Zeiger RS, Borish L et al. Key findings and clinical implications from The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) study. J Allergy Clin Immunol 2012;130:332. https://doi.org/10.1016/J.JACI.2012.04.014
Riccardi E, Guida G, Garino S et al. Biologics in T2 Severe Asthma: Unveiling Different Effectiveness by Real-World Indirect Comparison. J Clin Med 2024;13. https://doi.org/10.3390/JCM13164750
Maspero J, Pavie J, Torres-Duque CA et al. Toward a better understanding of severe asthma phenotypes in Latin America: results from the PREPARE study. Curr Med Res Opin 2023;39:627–38. https://doi.org/10.1080/03007995.2023.2174328
Forno E, Gogna M, Cepeda A et al. Asthma in Latin America. Thorax 2015;70:898–905. https://doi.org/10.1136/thoraxjnl-2015-207199
Rosser FJ, Forno E, Cooper PJ, Celedón JC. Asthma in Hispanics. An 8-year update. Am J Respir Crit Care Med 2014;189:1316–27. https://doi.org/10.1164/RCCM.201401-0186PP
Mallol J, Solé D, Baeza-Bacab M, Aguirre-Camposano V, Soto-Quiros M, Baena-Cagnani C. Regional variation in asthma symptom prevalence in Latin American children. J Asthma 2010;47:644–50. https://doi.org/10.3109/02770901003686480
Harris PA, Taylor R, Minor BL et al. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform 2019;95:103208. https://doi.org/10.1016/J.JBI.2019.103208
Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform 2009;42:377–81. https://doi.org/10.1016/J.JBI.2008.08.010
Lee JH, Haselkorn T, Borish L, Rasouliyan L, Chipps BE, Wenzel SE. Risk factors associated with persistent airflow limitation in severe or difficult-to-treat asthma: Insights from the TENOR study. Chest 2007;132:1882–9. https://doi.org/10.1378/chest.07-0713
Bourdin A, Brusselle G, Couillard S et al. Phenotyping of Severe Asthma in the Era of Broad-Acting Anti-Asthma Biologics. J Allergy Clin Immunol Pract 2024;12:809–23. https://doi.org/10.1016/J.JAIP.2024.01.023