Local budesonide therapy in the management of persistent hyposmia in suspected non-severe COVID-19 patients : Results of a randomized controlled trial
Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved..
OBJECTIVES: 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.
METHODS: 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.
RESULTS: 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).
CONCLUSION: 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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:136 |
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| Enthalten in: |
International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases - 136(2023) vom: 01. Nov., Seite 70-76 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Hautefort, Charlotte [VerfasserIn] |
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| Links: |
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| Themen: |
51333-22-3 |
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| Anmerkungen: |
Date Completed 27.10.2023 Date Revised 27.10.2023 published: Print-Electronic ClinicalTrials.gov: NCT04361474 Citation Status MEDLINE |
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| doi: |
10.1016/j.ijid.2023.08.022 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM361499175 |
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| 100 | 1 | |a Hautefort, Charlotte |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Local budesonide therapy in the management of persistent hyposmia in suspected non-severe COVID-19 patients |b Results of a randomized controlled trial |
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| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT04361474 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved. | ||
| 520 | |a OBJECTIVES: 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 | ||
| 520 | |a METHODS: 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 | ||
| 520 | |a RESULTS: 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) | ||
| 520 | |a CONCLUSION: 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 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
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| 700 | 1 | |a Jourdaine, Clément |e verfasserin |4 aut | |
| 700 | 1 | |a Housset, Juliette |e verfasserin |4 aut | |
| 700 | 1 | |a Eliezer, Michael |e verfasserin |4 aut | |
| 700 | 1 | |a Verillaud, Benjamin |e verfasserin |4 aut | |
| 700 | 1 | |a Slama, Dorsaf |e verfasserin |4 aut | |
| 700 | 1 | |a Ayache, Denis |e verfasserin |4 aut | |
| 700 | 1 | |a Herman, Philippe |e verfasserin |4 aut | |
| 700 | 1 | |a Yavchitz, Amélie |e verfasserin |4 aut | |
| 700 | 1 | |a Guillaume, Jessica |e verfasserin |4 aut | |
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| 700 | 1 | |a Bakkouri, Wissame El |e verfasserin |4 aut | |
| 700 | 1 | |a Salmon, Dominique |e verfasserin |4 aut | |
| 700 | 1 | |a Daval, Mary |e verfasserin |4 aut | |
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