Add-on inhaled budesonide in the treatment of hospitalised patients with COVID-19: a randomised clinical trial
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).
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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.
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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.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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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).
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 (https://doi.org/10.1183/13993003.03036-2021).
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
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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
permissions@ersnet.org
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:..
Late treatment
is less effective
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