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OutcomePhase 2NCT04918953

Factors Influencing the Prognosis of Olfactory Dysfunction After Upper Sensation

A Phase 2 study testing methylprednisolone and budesonide atomization suspension in people with Outcome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Objective: This study aimed to analyze the outcomes of post-infectious olfactory dysfunction treated with different doses of corticosteroids and specify factors related to the curative effect. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Outcome
What is being tested?
methylprednisolone and budesonide atomization suspension
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
2 Jun 2021to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The history of upper respiratory tract infection was confirmed, and the previous sense of smell was normal.

Who cannot join

  • Other causes of olfactory disorder suggested by the history

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Department of Otolaryngology, Second Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310000

    Hong-Gang Duan, doctor, 86(China)-571-87783774, 2314061@zju.edu.cn

Other trials in China

About this study

Official title: Second Affiliated Hospital, College of Medicine, Zhejiang University

Objective: This study aimed to analyze the outcomes of post-infectious olfactory dysfunction treated with different doses of corticosteroids and specify factors related to the curative effect. Methods: The medical records of patients diagnosed with post-infectious olfactory dysfunction from January 2020 to december 2025 were reviewed. All patients were treated with different doses of oral corticosteroids for 12 days or they inhaled corticosteroids for 1 month.

Read the detailed description

All patients underwent nasal endoscopy and magnetic resonance imaging (MRI) of the olfactory pathway.

At least 1 week after the symptoms such as nasal congestion and runny nose subsided, olfactory disorders did not improve. Nasal sinusitis and other lesions were excluded by physical and endoscopic examinations and imaging (sinus computed tomography and MRI), and the disorder defined as post-infectious olfactory dysfunction. All participants had a clear history of upper respiratory tract infection; other causes of olfactory disorders were excluded.

All patients underwent a subjective olfactory test at the first visit and after the last treatment. The olfactory detection threshold and recognition threshold were tested using a T\&T olfactory meter (Japan's First Drug Industry Co., Ltd.),which is commonly used in patients suffering from smelling disorders in asian, and correlate well with The University of Pennsylvania Smell Identification Test (UPSIT)[13]. The test was carried out according to the instructions on the olfactory meter, and the average recognition threshold of five olfactory elements was calculated to determine the degree of olfactory loss. The test results revealed normal (<1.0), mildly decreased (1.1 ≤ 2.5), moderately decreased (2.6 ≤ 4.0), severely decreased (4.1 ≤ 5.5), and complete lack of the sense of smell (> 5.5). In order to reduce the learning effects of repeated testing, all patients were order to close their eyes during the test.

The patients were treated with three protocols: (1) oral methylprednisolone, 40 mg for 3 days, 20 mg for 3 days, and 8 mg for 6 days; (2) oral methylprednisolone, 20 mg for 3 days, 10 mg for 3 days, and 4 mg for 6 days; and (3) budesonide atomization suspension (AstraZeneca Trading Co., Ltd.) inhaled through the nose atomized with an air compression atomizer for 4 weeks, 2 mg for the first 2 weeks and reduced to 1 mg for the last 2 weeks. At the same time, all patients received olfactory training for 12 weeks as proposed by Hummel et al[3].

A repeat T\&T subjective olfactory test will be performed after the treatment. Patients with normal sense of smell will be defined as cured; patients with average T\&T recognition threshold decreased by 1 point will be defined as improved; patients with average T\&T recognition threshold decreased by 2 points or more, which did not reach the normal range, will be defined as significantly improved; and patients with average T\&T recognition threshold decreased by 1 point, with or without falling, will be defined as invalid.

SAS 9.4 software was used for statistical analysis. The treatment plan was divided into three groups, and the dependent variable was a disordered three categorical variable. The description of the numerical variables of the normal distribution adopts the mean ± standard deviation, and the analysis of variance is used for statistical analysis; the description of the numerical variables of the non-normal distribution adopts the median (interquartile range), and the rank sum test of multi-sample comparison with a completely random design is adopted conduct statistical analysis. Categorical variables are described by R*C contingency table, and the chi-square test and Fisher exact probability method are used for statistical analysis. The alpha level of the statistical test is set to 0.05.

Conditions
Outcome
Being tested
methylprednisolone, budesonide atomization suspension
Keywords
Corticosteroid, olfactory dysfunction, Smell.
Medical subject headings
Anosmia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • methylprednisoloneDrug

    Also called Olfactory training

    The patients were treated with three protocols: (1) oral methylprednisolone, 40 mg for 3 days, 20 mg for 3 days, and 8 mg for 6 days; (2) oral methylprednisolone, 20 mg for 3 days, 10 mg for 3 days, and 4 mg for 6 days. At the same time, all patients received olfactory training for 12 weeks as proposed by Hummel et al

  • budesonide atomization suspensionDrug

    Also called Olfactory training

    (3) budesonide atomization suspension (AstraZeneca Trading Co., Ltd, AU.) inhaled through the nose atomized with an air compression atomizer for 4 weeks, 2 mg for the first 2 weeks and reduced to 1 mg for the last 2 weeks. At the same time, all patients received olfactory training for 12 weeks as proposed by Hummel et al

Study groups in NCT04918953
Study groupRoleWhat they receive
group 1Experimentaloral methylprednisolone, 40 mg for 3 days, 20 mg for 3 days, and 8 mg for 6 days
Receives: Drug: methylprednisolone
group 2Experimentaloral methylprednisolone, 20 mg for 3 days, 10 mg for 3 days, and 4 mg for 6 days
Receives: Drug: methylprednisolone
group 3Experimentalbudesonide atomization suspension (AstraZeneca Trading Co., Ltd, AU.) inhaled through the nose atomized with an air compression atomizer for 4 weeks, 2 mg for the first 2 weeks and reduced to 1 mg for the last 2 weeks.
Receives: Drug: budesonide atomization suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall effective rate

    A repeat T\&T subjective olfactory test will be performed after the treatment. Patients with normal sense of smell will be defined as cured; patients with average T\&T recognition threshold decreased by 1 point will be defined as improved; patients with average T\&T recognition threshold decreased by 2 points or more, which did not reach the normal range, will be defined as significantly improved; and patients with average T\&T recognition threshold decreased by 1 point, with or without falling, will be defined as invalid.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start2 Jun 2021 (estimated)
  3. Primary completion30 Dec 2025 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04918953
Sponsor's protocol ID
2020-151
Status last verified
Jun 2021
First submitted
2 Jun 2021
Last updated
9 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: no result to share

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing methylprednisolone and budesonide atomization suspension in people with Outcome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hong-Gang Duan, doctor (86(China)-571-87783774, 2314061@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall effective rate (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2021.

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