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.
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
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.
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 group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | oral methylprednisolone, 40 mg for 3 days, 20 mg for 3 days, and 8 mg for 6 days Receives: Drug: methylprednisolone |
| group 2 | Experimental | oral methylprednisolone, 20 mg for 3 days, 10 mg for 3 days, and 4 mg for 6 days Receives: Drug: methylprednisolone |
| group 3 | Experimental | 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. Receives: Drug: budesonide atomization suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted9 Jun 2021
- Study start2 Jun 2021 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OutcomeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ze-xing Chen, master, Principal investigator, Second Affiliated Hospital, College of Medicine, Zhejiang University
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Affiliated Hospital, College of Medicine, Zhejiang University
- ClinicalTrials.gov ID
- NCT04918953
- Acronym / sponsor ID
- 2020-151
- Conditions
- Outcome
- Keywords
- Corticosteroid, olfactory dysfunction, Smell.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 2 Jun 2021 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: methylprednisoloneoral methylprednisolone, 40 mg for 3 days, 20 mg for 3 days, and 8 mg for 6 days |
| group 2 | Experimental | Drug: methylprednisoloneoral methylprednisolone, 20 mg for 3 days, 10 mg for 3 days, and 4 mg for 6 days |
| group 3 | Experimental | Drug: budesonide atomization suspensionbudesonide 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The history of upper respiratory tract infection was confirmed, and the previous sense of smell was normal.
Key exclusion criteria (1 listed)
- Other causes of olfactory disorder suggested by the history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisoloneAlso: Olfactory trainingThe 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 | Drug | group 1, group 2 |
| budesonide atomization suspensionAlso: 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 | Drug | group 3 |
Primary outcome
overall effective rate
Time frame: 5 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2021.
- Individual participant dataSharing planned: No. no result to share
Related trials for Outcome
Recruiting
Effect of Rutin and Vitamin C on Outcomes in Adults With Sepsis Admitted to the Intensive Care Unit
Sepsis
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Enrolling by invitationObservational study
North American Fetal Therapy Network Prospective Registry for Long-term Outcome Following Fetoscopic Endoluminal Tracheal Occlusion in Severe Left and Right Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ze-xing Chen, master principal investigator
Second Affiliated Hospital, College of Medicine, Zhejiang University
1 site in 1 country: see every site and its status.
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.