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Trial Evaluating the Efficacy of Local Budesonide Therapy in the Management of Hyposmia in COVID-19 Patients Without Signs of Severity

NCT04361474 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-01-06

No results posted yet for this study

Summary

The initial symptoms described in the first cases of COVID-19 were mainly fever and respiratory signs. Recently, there has been an increase in cases of hyposmia without associated nasal obstruction or rhinorrhea. Although we do not yet know the long-term consequences of COVID-19 on olfaction, there is evidence in the literature demonstrating that post-viral hyposmias are an important source of long-term olfactory disorders, impacting quality of life.

Usually, the treatment of viral hyposmias is based on local and/or general corticosteroid treatment combined with saline nasal irrigation at the onset of signs. Because of the possible development of severe forms of the SARS-Cov-2 infection, the French Society of Otorhinolaryngology has advised against treatment by corticosteroid therapy and nasal irrigation. However, as the virus is present in the nasal fossae on average for 20 days, persistent hyposmia at 30 days would probably result from an inflammatory or neurological damage to the nasal slits or olfactory bulb. Local treatment with corticosteroids could then be instituted from 30 days after the onset of symptoms of COVID-19 without risk of dissemination.

In persistent hyposmia other than chronic rhinosinusitis, the only treatment that has proven its efficacy is nasal irrigation associated with budesonide and olfactory rehabilitation. However, this drug does not have marketing authorisation in France for this indication.

Conditions

  • Budesonide
  • Olfaction Disorders
  • SARS-CoV-2
  • Anosmia

Interventions

DRUG

Budesonide Nasal

Nasal irrigation with budesonide and physiological saline morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.

OTHER

Physiological serum

Nasal irrigation with physiological saline morning and evening, for 30 days, in addition to olfactory re-education twice a day.

Sponsors & Collaborators

  • Hopital Lariboisière

    collaborator OTHER

  • Fondation Ophtalmologique Adolphe de Rothschild

    lead NETWORK

Principal Investigators

  • Mary DAVAL · Hopital Fondation A de Rothschild

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-18
Primary Completion
2020-11-24
Completion
2021-06-25

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04361474 on ClinicalTrials.gov