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Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial

Agustí et al., European Respiratory Journal, doi:10.1183/13993003.03036-2021, TACTIC, NCT04355637
Feb 2022  
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0 0.5 1 1.5 2+ Mortality -23% Improvement Relative Risk Progression 39% Budesonide  TACTIC  LATE TREATMENT  RCT Is late treatment with budesonide beneficial for COVID-19? RCT 89 patients in Spain (April 2020 - March 2021) Trial underpowered to detect differences Agustí et al., European Respiratory J., Feb 2022 Favors budesonide Favors control
Budesonide for COVID-19
18th treatment shown to reduce risk in April 2021
*, now known with p = 0.0000011 from 15 studies, recognized in 8 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments.
Small early-terminated RCT with 40 inhaled budesonide and 49 control patients, showing no significant differences. 400µg/12h via Pulmicort Turbuhaler.
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects (early treatment may be more beneficial).
risk of death, 22.5% higher, RR 1.23, p = 1.00, treatment 1 of 40 (2.5%), control 1 of 49 (2.0%), day 90.
risk of progression, 38.7% lower, RR 0.61, p = 0.69, treatment 2 of 40 (5.0%), control 4 of 49 (8.2%), NNT 32.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Agustí et al., 10 Feb 2022, Randomized Controlled Trial, Spain, peer-reviewed, 21 authors, study period 21 April, 2020 - 16 March, 2021, trial NCT04355637 (history) (TACTIC).
This PaperBudesonideAll
Abstract: Early View Research letter Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial Alvar Agustí, Gaston De Stefano, Alberto Levi, Xavier Muñoz, Christian Romero-Mesones, Oriol Sibila, Alejandra Lopez-Giraldo, Vicente Plaza Moral, Elena Curto, Andrés L. Echazarreta, Silvana E. Márquez, Sergi Pascual-Guàrdia, Salud Santos, Alicia Marin, Luis Valdés, Fernando Saldarini, Clara Salgado, Georgina Casanovas, Sara Varea, José Ríos, Rosa Faner Please cite this article as: Agustí A, De Stefano G, Levi A, et al. Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial. Eur Respir J 2022; in press ( This manuscript has recently been accepted for publication in the European Respiratory Journal. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJ online. Copyright ©The authors 2022. This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact January 20, 2022 Research letter ERJ-03036-2021 SECOND REVISION ADD-ON INHALED BUDESONIDE IN THE TREATMENT OF HOSPITALIZED PATIENTS WITH COVID-19: A RANDOMIZED CLINICAL TRIAL Alvar Agustí1-4, Gaston De Stefano5, Alberto Levi5, Xavier Muñoz4,6,7, Christian Romero-Mesones4,6, Oriol Sibila1-4, Alejandra Lopez-Giraldo2-4, Vicente Plaza Moral4,8-10, Elena Curto4,8-10, Andrés L. Echazarreta11, Silvana E. Márquez11, Sergi Pascual-Guàrdia4,12,13, Salud Santos2,4,14,15, Alicia Marin4,16, Luis Valdés17-19, Fernando Saldarini20, Clara Salgado21, Georgina Casanovas1,3, Sara Varea1,3, José Ríos1,3,7, Rosa Faner2-4 1. Hospital Clinic, Barcelona, Spain. 2. Universitat Barcelona, Spain. 3. Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain. 4. CIBER Enfermedades Respiratorias, Spain. 5. Servicio de Neumotisiologia, Hospital Francisco Muñiz, Buenos Aires, Argentina 6. Servei Pneumologia H. Vall d’Hebron, Barcelona Spain. 7. Biostatistics Unit, Faculty of Medicine, Universitat Autònoma de Barcelona 8. Department of Respiratory Medicine, Hospital de la Santa Creu i Sant Pau. Barcelona, Spain 9. Institut d’Investigació Biomédica Sant Pau (IIB Sant Pau). Barcelona, Spain 10. Universitat Autònoma de Barcelona, Department of Medicine, Barcelona, Spain 11. Servicio de Neumonología, Hospital San Juan de Dios de La Plata, Buenos Aires, Argentina 12. Servei de Pneumologia, Hospital del Mar - IMIM. Barcelona, Spain 13. Universitat Pompeu Fabra. Barcelona, Spain 14. Department of Pulmonary Medicine, Bellvitge University Hospital, L’Hospitalet de Llobregat, Barcelona, Spain 15. Institut d’Investigació Biomèdica de Bellvitge – IDIBELL, Spain 16. Hospital Universitari Germans Trias i Pujol, Badalona, Spain 17. Servicio de Neumología. Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain 18. Instituto de Investigaciones Sanitarias (IDIS), Santiago de Compostela, Spain 19. Universidad de Santiago de Compostela, Spain 20. Sección de Neumotisiologia. Hospital Donación Francisco Santojanni, Buenos Aires, Argentina. 21. Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno Correspondence:..
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Late treatment
is less effective
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