Smell DysfunctionPIODNCT07386860
The Effectiveness of Steroid Nasal Drops in the Olfactory Cleft Combined With Olfactory Training for Patients With PIOD
A study testing Steroid nasal drops combined with olfactory training in people with Smell Dysfunction, run by Peking University Third Hospital at 1 site in China.
Trial summary
This study aims to evaluate the effectiveness of hormone nasal drops in the olfactory cleft combined with olfactory training for treating postinfectious olfactory dysfunction (PIOD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smell Dysfunction
- What is being tested?
- Steroid nasal drops combined with olfactory training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2028
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prospective enrollment of otolaryngology clinic patients aged 18-65 years with olfactory dysfunction. Diagnosis of post-infectious olfactory dysfunction (PIOD) will be based on the PPOD 2023 criteria. Participants must demonstrate olfactory impairment via Sniffin' Sticks testing, with TDI scores (sum of Threshold, Discrimination, and Identification) meeting: (1) Hyposmia: 16 < TDI < 30.75; (2) Anosmia: TDI ≤ 15.
- Willingness to participate and signed informed consent.
Who cannot join
- Use of systemic corticosteroids within 4 weeks or intranasal steroids within 2 weeks prior to enrollment.
- Severe nasal septum deviation, nasal tumors, acute upper respiratory infections, or uncontrolled allergic rhinitis.
- History of functional endoscopic sinus surgery or other nasal procedures within 12 months.
- Severe cardiovascular disease, hepatic/renal insufficiency, uncontrolled diabetes, or immune system disorders.
- Current or planned pregnancy.
- Investigator-determined inability to comply with study requirements (e.g., memory/behavioral disorders, depression, heavy alcohol use, prior non-compliance).
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
Dawei Wu
Beijing, Beijing Municipality, 100191
Dawei Wu, MD, PhD, 13522503401, davidwuorl@163.com
About this study
Official title: Randomized Controlled Study on the Effectiveness of Steroid Nasal Drops in the Olfactory Cleft Combined With Olfactory Training for Patients With Post-infectious Olfactory Dysfunction
This study aims to evaluate the effectiveness of hormone nasal drops in the olfactory cleft combined with olfactory training for treating postinfectious olfactory dysfunction (PIOD). The main questions this clinical trial seeks to answer are:
Can the combination of hormone nasal drops and olfactory training improve smell function better than olfactory training alone in PIOD patients? How does this combined treatment work?
Read the detailed description
Post-infectious olfactory dysfunction (PIOD) is a prevalent condition, particularly following viral upper respiratory infections such as COVID-19, and significantly impacts patients' quality of life. Current treatments primarily rely on olfactory training, but its effectiveness varies, with improvement rates ranging between 30% and 50%. Emerging evidence suggests that olfactory cleft obstruction and chronic inflammation play critical roles in PIOD pathogenesis, highlighting the potential benefits of targeted steroid therapy to address these underlying mechanisms.
In this study, the investigators planned to recruit 100 patients and divided them into two groups for combined therapy with steroid drops or placebo drops alongside olfactory training, and validate the effectiveness of the combined therapy based on the comparison of the outcomes of the two groups.
- Conditions
- Smell Dysfunction
- Being tested
- Steroid nasal drops combined with olfactory training, Placebo nasal drops combined with olfactory training
- Keywords
- post-infectious olfactory dysfunction, olfactory training, steroid drops, combined therapy
- Medical subject headings
- Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid nasal drops combined with olfactory trainingCombination product
The intervention consists of two components: steroid nasal drops and modified olfactory training.
Placebo nasal drops combined with olfactory trainingCombination product
The intervention consists of two components: normal saline nasal drops and modified olfactory training.
| Study group | Role | What they receive |
|---|---|---|
| Hormone Nasal Drops Combined with Olfactory Training Group | Experimental | Olfactory Cleft Steroid Nasal Drops: Patients will be instructed to assume the Mygind position. Five drops of budesonide suspension (2ml:1mg) will be instilled into each nostril to facilitate delivery to the olfactory cleft. This position will be maintained for 5 minutes, after which patients should expectorate any residual medication. The treatment regimen will follow a tapered schedule: twice daily during the first treatment month, reduced to once daily in the second month, and further reduced to every other day in the third month.
Olfactory Training: Participants will perform olfactory training using a modified training device programmed with four distinct odorants (rose, peppermint, tea tree, and clove). Each odorant will be sniffed for 10 seconds per nostril, with 10-second intervals between odorants. Each training session lasts 5 minutes and is conducted twice daily, before breakfast and at bedtime, for a duration of 3 months. Receives: Combination Product: Steroid nasal drops combined with olfactory training |
| Placebo Nasal Drops Combined with Olfactory Training Group | Placebo comparator | The placebo group will receive normal saline nasal drops, with all other procedures identical to those in the intervention group. Receives: Combination Product: Placebo nasal drops combined with olfactory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Sniffin' Sticks test
A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)
Measured: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
Secondary outcomes (6)
Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)
The QOD-NS includes 17 negative statements, each graded from 0 (disagree) to 3 (agree) for a maximum score of 51. Higher QOD-NS scores reflect worse QoL.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
Olfactory-Visual Analogue Scale (VAS)
Subjects rate the impact of smell loss on their mood, ability to enjoy food, social interactions, safety, personal hygiene, sex life, ability to cook food, appetite and change in weight from 0 (no impact) to 10 (most impact) for a maximum score of 90. Higher olfactory-VAS scores reflect more severe impacts on daily life.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
CT Evaluation of Olfactory Cleft Blockage
The olfactory cleft was divided into anterior and posterior, divided by the anterior end of the superior turbinate. The anterior and posterior olfactory cleft opacifications were graded separately on a scale of 0-4 by the ratio of the opacified area to the whole area of the olfactory cleft, with 0 (no opacification),
1 (25%), 2 (25%-50%), 3 (50%-75%), and 4 (>75%). The olfactory cleft CT score, calculated as the sum of the anterior and posterior olfactory cleft scores, ranged from 1 to 8 (Kim DW, Kim JY, Jeon SY. The status of the olfactory cleft may predict postoperative olfactory function in chronic rhinosinusitis with nasal polyposis. Am J Rhinol Allergy. 2011;25(2):e90-4.).
Measured: Baseline and 12 weeks after the initiation of treatment.
Inflammatory Marker Levels in Olfactory Mucosa
Analysis of inflammatory cytokines （IL-4、IL-5、IL-13、IL-25、IL-33 and TSLP）via ELISA and single-cell sequencing from olfactory mucosal brush samples.
Measured: Baseline and 12 weeks after the initiation of treatment.
Plasma Cortisol Levels
Measurement of systemic cortisol concentrations through venous blood sampling
Measured: Baseline and 12 weeks after the initiation of treatment.
Adverse Event
Documentation of local (nasal irritation, epistaxis) and systemic steroid-related adverse events using standardized case report forms during all follow-up visits.
Measured: 2 weeks, and 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smell DysfunctionStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawei Wu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386860
- Sponsor's protocol ID
- 9059106
- Acronym
- PIOD
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will decide whether to share the individual participant data after the study.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on the Effectiveness of Steroid Nasal Drops in the Olfactory Cleft Combined With Olfactory Training for Patients With Post-infectious Olfactory Dysfunction
- ClinicalTrials.gov ID
- NCT07386860
- Acronym / sponsor ID
- PIOD / 9059106
- Conditions
- Smell Dysfunction
- Keywords
- post-infectious olfactory dysfunction, olfactory training, steroid drops, combined therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Feb 2026 (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.
This study aims to evaluate the effectiveness of hormone nasal drops in the olfactory cleft combined with olfactory training for treating postinfectious olfactory dysfunction (PIOD). The main questions this clinical trial seeks to answer are:
Can the combination of hormone nasal drops and olfactory training improve smell function better than olfactory training alone in PIOD patients? How does this combined treatment work?
Detailed description
Post-infectious olfactory dysfunction (PIOD) is a prevalent condition, particularly following viral upper respiratory infections such as COVID-19, and significantly impacts patients' quality of life. Current treatments primarily rely on olfactory training, but its effectiveness varies, with improvement rates ranging between 30% and 50%. Emerging evidence suggests that olfactory cleft obstruction and chronic inflammation play critical roles in PIOD pathogenesis, highlighting the potential benefits of targeted steroid therapy to address these underlying mechanisms.
In this study, the investigators planned to recruit 100 patients and divided them into two groups for combined therapy with steroid drops or placebo drops alongside olfactory training, and validate the effectiveness of the combined therapy based on the comparison of the outcomes of the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hormone Nasal Drops Combined with Olfactory Training Group | Experimental | Combination Product: Steroid nasal drops combined with olfactory trainingOlfactory Cleft Steroid Nasal Drops: Patients will be instructed to assume the Mygind position. Five drops of budesonide suspension (2ml:1mg) will be instilled into each nostril to facilitate delivery to the olfactory cleft. This position will be maintained for 5 minutes, after which patients should expectorate any residual medication. The treatment regimen will follow a tapered schedule: twice daily during the first treatment month, reduced to once daily in the second month, and further reduced to every other day in the third month. Olfactory Training: Participants will perform olfactory training using a modified training device programmed with four distinct odorants (rose, peppermint, tea tree, and clove). Each odorant will be sniffed for 10 seconds per nostril, with 10-second intervals between odorants. Each training session lasts 5 minutes and is conducted twice daily, before breakfast and at bedtime, for a duration of 3 months. |
| Placebo Nasal Drops Combined with Olfactory Training Group | Placebo comparator | Combination Product: Placebo nasal drops combined with olfactory trainingThe placebo group will receive normal saline nasal drops, with all other procedures identical to those in the intervention group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Prospective enrollment of otolaryngology clinic patients aged 18-65 years with olfactory dysfunction. Diagnosis of post-infectious olfactory dysfunction (PIOD) will be based on the PPOD 2023 criteria. Participants must demonstrate olfactory impairment via Sniffin' Sticks testing, with TDI scores (sum of Threshold, Discrimination, and Identification) meeting: (1) Hyposmia: 16 < TDI < 30.75; (2) Anosmia: TDI ≤ 15.
- Willingness to participate and signed informed consent.
Key exclusion criteria (6 listed)
- Use of systemic corticosteroids within 4 weeks or intranasal steroids within 2 weeks prior to enrollment.
- Severe nasal septum deviation, nasal tumors, acute upper respiratory infections, or uncontrolled allergic rhinitis.
- History of functional endoscopic sinus surgery or other nasal procedures within 12 months.
- Severe cardiovascular disease, hepatic/renal insufficiency, uncontrolled diabetes, or immune system disorders.
- Current or planned pregnancy.
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 |
|---|---|---|
| Steroid nasal drops combined with olfactory trainingThe intervention consists of two components: steroid nasal drops and modified olfactory training. | Combination product | Hormone Nasal Drops Combined with Olfactory Training Group |
| Placebo nasal drops combined with olfactory trainingThe intervention consists of two components: normal saline nasal drops and modified olfactory training. | Combination product | Placebo Nasal Drops Combined with Olfactory Training Group |
Primary outcome
The Sniffin' Sticks test
Time frame: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)
6 secondary outcomes
Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
Olfactory-Visual Analogue Scale (VAS)
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
CT Evaluation of Olfactory Cleft Blockage
Time frame: Baseline and 12 weeks after the initiation of treatment.
Inflammatory Marker Levels in Olfactory Mucosa
Time frame: Baseline and 12 weeks after the initiation of treatment.
Plasma Cortisol Levels
Time frame: Baseline and 12 weeks after the initiation of treatment.
Adverse Event
Time frame: 2 weeks, and 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
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 4 Feb 2026.
- Individual participant dataSharing planned: No. We will decide whether to share the individual participant data after the study.
Related trials for Smell Dysfunction
Not yet recruitingEarly Phase 1
In Vivo Imaging of the Olfactory Epithelium Using Confocal Laser Endomicroscopy
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Topical Versus Injection PRP for Olfactory Dysfunction
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Acupuncture for Post-traumatic Olfactory Dysfunction: A Randomized Controlled Trial
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steroid nasal drops combined with olfactory training in people with Smell Dysfunction, run by Peking University Third Hospital 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 2 inclusion and 6 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 4 Feb 2026. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Dawei Wu, MD, PhD (13522503401, davidwuorl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Sniffin' Sticks test (time frame: Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the initiation of treatment.). 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 4 Feb 2026.