Local budesonide therapy in the management of persistent hyposmia in suspected non-severe COVID-19 patients: Results of a randomized controlled trial.


Journal

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
ISSN: 1878-3511
Titre abrégé: Int J Infect Dis
Pays: Canada
ID NLM: 9610933

Informations de publication

Date de publication:
Nov 2023
Historique:
received: 16 04 2023
revised: 20 08 2023
accepted: 25 08 2023
medline: 27 10 2023
pubmed: 1 9 2023
entrez: 31 8 2023
Statut: ppublish

Résumé

Consequences of COVID-19 on olfactory functions remained unclear during the pandemic. We assessed the efficacy of local budesonide in addition to olfactory rehabilitation when managing non-severe COVID-19 patients with persistent hyposmia. A multicentric, randomized, superiority trial was conducted (ClinicalTrials.gov NCT04361474). The experimental group (EG) received budesonide and physiological saline nasal irrigations administered via three syringes of 20 ml in each nasal cavity in the morning and evening for 30 days. The control group (CG) received a similar protocol without budesonide. Patients were included if they were >18 years old, with a SARS-CoV-2 infection and presenting an isolated hyposmia persisting 30 days after symptom onset. The primary endpoint was the percentage of patients with improvement of more than two points on the ODORATEST score after 30 days of treatment. In total, 123 patients were included and randomized (EG: 62 vs CG: 61). Two patients from the EG met the primary endpoint with no statistical difference between the two groups (P = 0.5). To our knowledge, this is the first study evaluating local budesonide for COVID-19 related hyposmia treatment even though previous trials were performed with other local corticosteroids. Local budesonide efficacy was not demonstrated for persistent hyposmia related to COVID-19.

Identifiants

pubmed: 37652094
pii: S1201-9712(23)00707-5
doi: 10.1016/j.ijid.2023.08.022
pii:
doi:

Substances chimiques

Budesonide 51333-22-3
Adrenal Cortex Hormones 0

Banques de données

ClinicalTrials.gov
['NCT04361474']

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

70-76

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Declarations of competing interest The authors have no competing interests to declare.

Auteurs

Charlotte Hautefort (C)

Hôpital Lariboisière, Université de Paris, APHP, ENT Department, Paris, France.

Alain Corré (A)

Hôpital Fondation Adolphe de Rothschild, ENT Department, Paris, France.

Guillaume Poillon (G)

Hôpital Fondation Adolphe de Rothschild, Imaging Department, Paris, France.

Clément Jourdaine (C)

Hôpital Lariboisière, Université de Paris, APHP, ENT Department, Paris, France.

Juliette Housset (J)

Hôpital Lariboisière, Université de Paris, APHP, ENT Department, Paris, France.

Michael Eliezer (M)

Hôpital Lariboisière, Université de Paris, APHP, Neuroradiology Department, Paris, France.

Benjamin Verillaud (B)

Hôpital Lariboisière, Université de Paris, APHP, ENT Department, Paris, France.

Dorsaf Slama (D)

Hôpital Hotel Dieu, Université de Paris, APHP, Department of Infectious Disease, Paris, France.

Denis Ayache (D)

Hôpital Fondation Adolphe de Rothschild, ENT Department, Paris, France.

Philippe Herman (P)

Hôpital Lariboisière, Université de Paris, APHP, ENT Department, Paris, France.

Amélie Yavchitz (A)

Hôpital Fondation Adolphe de Rothschild, Clinical Research Department, Paris, France.

Jessica Guillaume (J)

Hôpital Fondation Adolphe de Rothschild, Clinical Research Department, Paris, France.

Camille Hervé (C)

Hôpital Fondation Adolphe de Rothschild, ENT Department, Paris, France.

Wissame El Bakkouri (WE)

Hôpital Fondation Adolphe de Rothschild, ENT Department, Paris, France.

Dominique Salmon (D)

Hôpital Hotel Dieu, Université de Paris, APHP, Department of Infectious Disease, Paris, France.

Mary Daval (M)

Hôpital Fondation Adolphe de Rothschild, ENT Department, Paris, France. Electronic address: mdaval@for.paris.

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Classifications MeSH