Chronic Rhinosinusitis (CRS)NCT07386873
Position-Directed Budesonide Nasal Drops for CRS-associated Olfactory Dysfunction
A study testing Nasal Drops and Nasal Spray in people with Chronic Rhinosinusitis (CRS) and Olfactory Dysfunction, run by Peking University Third Hospital at 1 site in China.
Trial summary
This single-center randomized controlled trial evaluates whether budesonide nasal drops delivered in the Wu's position (Wu's 45° Head-Hanging Reclination Position) improve olfactory function more effectively than conventional budesonide nasal spray in adults with type 2 chronic rhinosinusitis (CRS)-related olfactory… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Rhinosinusitis (CRS), Olfactory Dysfunction
- What is being tested?
- Nasal Drops and Nasal Spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 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
- Men and women aged 18-65 years old.
- Diagnosis of CRS according to the EPOS 2020, with olfactory dysfunction lasting ≥ 12 weeks.
- Evidence of eosinophilic/type 2 inflammatory CRS, defined by at least one of the following: JESREC score ≥11, peripheral blood eosinophils ≥5%, absolute blood eosinophil count ≥ 0.25 × 10⁹/L.
- Confirmation of OD via Sniffin' Sticks test: TDI score <30.75 (hyposmia: 16 < TDI < 30.75; anosmia: TDI ≤ 16).
- Sinus CT scan confirming olfactory cleft abnormalities (e.g., mucosal thickening, polypoid changes, obstruction).
- Willingness to participate in this study and sign the informed consent form (ICF).
Who cannot join
- Patients who have used systemic corticosteroids within the past 4 weeks or who have used intranasal corticosteroids within the past 2 weeks, or biologic therapy targeting type 2 inflammation within 6 months before enrolment.
- Patients with severe deviation of the nasal septum, nasal tumors, acute upper respiratory tract infection or uncontrolled allergic rhinitis.
- Patients with severe cardiovascular diseases, liver or kidney dysfunction, uncontrolled diabetes, or immune system disorders or other systemic disease that may interfere with study participation or safety.
- Patients with current pregnancy or plan to become pregnant during the study period.
- Patients with known hypersensitivity or contraindication to budesonide or any study medication component.
- Patients who are unable to complete the study or are unable to comply with the requirements of the study (including inability to tolerate olfactory function testing and treatment, memory or behavioral abnormalities, depression, smoking, heavy alcohol use or prior non-compliance, specifically early withdrawal from a study).
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: Position-Directed Budesonide Nasal Drops for Olfactory Dysfunction in Eosinophilic Chronic Rhinosinusitis: A Randomized Controlled Trial
This single-center randomized controlled trial evaluates whether budesonide nasal drops delivered in the Wu's position (Wu's 45° Head-Hanging Reclination Position) improve olfactory function more effectively than conventional budesonide nasal spray in adults with type 2 chronic rhinosinusitis (CRS)-related olfactory dysfunction.
The study also evaluates patient-reported symptoms and quality of life, olfactory cleft structural abnormalities on sinus CT, computational fluid dynamics (CFD)-derived airflow parameters, safety, and whether baseline peripheral blood eosinophil count and clinical phenotype predict treatment response.
Read more
The main questions this clinical trial aims to answer are:
- Efficacy Comparison: Is olfactory improvement greater with olfactory cleft-targeted steroid nasal drops compared to standard nasal steroid sprays in CRS patients?
- Mechanism Exploration: How do changes in inflammatory markers, obstruction severity, and olfactory test results explain the potential benefits of this treatment approach?
- Disease Classification: Can post-treatment olfactory dysfunction be categorized as fully reversible, partially reversible, or non-responsive/irreversible using Week-12 TDI recovery?
Read the detailed description
Chronic rhinosinusitis (CRS)-related olfactory dysfunction may result from both obstruction of the olfactory cleft and persistent local inflammation. Conventional intranasal corticosteroid sprays may have limited and variable drug deposition in the olfactory cleft. This randomized controlled trial is designed to evaluate whether targeted delivery of budesonide nasal drops using the Wu's position (Wu's 45° Head-Hanging Reclination Position) provides greater olfactory improvement than conventional budesonide nasal spray in patients with eosinophilic/type 2 CRS-related olfactory dysfunction.
A total of 78 adults aged 18-65 years will be randomized 1:1 to receive either budesonide nasal drops administered in the Wu's position or conventional budesonide nasal spray for 12 weeks. Participants in the nasal-drop group will receive budesonide suspension, 20 drops per nostril twice daily, and will maintain the Wu's position for approximately 5 minutes after administration. Participants in the control group will receive conventional budesonide nasal spray, 2 actuations per nostril once daily in the upright sitting position.
Olfactory function will be assessed using Sniffin' Sticks, including odor threshold, discrimination, identification, and the composite TDI score. The primary outcome is the proportion of participants achieving a clinically meaningful TDI improvement of ≥5.5 points at Week 12. Additional assessments will include the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS), Olfactory-Visual Analogue Scale (VAS), the Sino-Nasal Outcome Test 22 (SNOT-22), Nasal Obstruction Symptom Evaluation (NOSE), and 4-item Concise Aging adults Smell Test (4-CAST). Sinus CT will be used to evaluate olfactory cleft structural abnormalities, while computational fluid dynamics (CFD) analysis will characterize olfactory cleft airflow.
At Week 12, olfactory recovery will also be classified as fully reversible, partially reversible, or non-responsive/irreversible according to the magnitude and completeness of TDI improvement. Baseline olfactory cleft CT findings, CFD-derived airflow parameters, peripheral blood eosinophil count, nasal polyp status, olfactory severity, and other clinical assessment scores will be explored as potential predictors of treatment response.
- Being tested
- Nasal Drops, Nasal Spray
- Keywords
- Olfactory dysfunction, Chronic rhinosinusitis, Steroid nasal drops, Olfactory cleft obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal DropsDevice
Participants will receive budesonide suspension (2 mL:1 mg) as nasal drops, 20 drops per nostril twice daily (morning and evening) for 12 weeks. The drops will be administered in the Wu's position (Wu's 45° Head-Hanging Reclination Position), with the head suspended and tilted backward approximately 45° and the nostrils facing upward. The position will be maintained for approximately 5 minutes after instillation.
Nasal SprayDevice
Participants will administer conventional budesonide nasal spray in the standard upright sitting position according to routine clinical practice, 2 actuations per nostril once daily. Participants will be instructed to sniff gently after each spray. Treatment will continue for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nasal Drops Group | Experimental | Not described Receives: Device: Nasal Drops |
| Standard Nasal Spray Group | Active comparator | Not described Receives: Device: Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants with Clinically Meaningful Improvement in the Sniffin' Sticks test
Proportion of participants achieving a clinically meaningful improvement in Sniffin' Sticks TDI score at Week 12. A responder is defined as a participant with an increase in the composite TDI score of ≥5.5 points from baseline. The TDI score is calculated as the sum of odor Threshold (T), Discrimination (D), and Identification (I) scores.
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
Secondary outcomes (6)
Subjective Olfactory Improvement and Nasal Symptoms
Patient-reported olfactory improvement measured using the Olfactory-Visual Analogue Scale (VAS) , 4-item Concise Aging adults Smell Test (4-CAST), nasal symptoms assessed via the Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire, olfactory-related quality of life assessed via the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS), and Nasal Obstruction Symptom Evaluation (NOSE). These measures evaluate treatment effects on self-perceived smell recovery and associated nasal complaints.
Measured: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
CT Evaluation of Olfactory Cleft Blockage
Structural assessment of the olfactory cleft, including mucosal thickening, polypoid change/obstruction, and the protocol-defined olfactory cleft CT score, with a maximum total score of 24.
Measured: Baseline , 4 weeks and 12 weeks after the initiation of treatment.
CFD Outcome
CFD-derived olfactory cleft airflow parameters Measure Description: Patient-specific computational fluid dynamics models will be reconstructed from sinus CT images to quantify olfactory cleft airflow velocity (m/s), volumetric flow rate (L/min), and olfactory cleft airflow ratio. These measures will be used as exploratory mechanistic and predictive variables.
Measured: Baseline, 4 weeks and 12 weeks after the initiation of treatment.
Inflammatory Marker Levels in Olfactory Mucosa
Analysis of inflammatory cytokines via ELISA and single-cell sequencing from olfactory mucosal brush samples, with concurrent serum inflammatory marker testing.
Measured: Baseline and 4 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: 1 week, and 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
Post-treatment Olfactory Reversibility Classification
At Week 12, participants will be categorized as:
Fully reversible: final TDI score ≥30.75; Partially reversible: TDI score increases by ≥5.5 points from baseline but remains <30.75; Non-responsive/irreversible: TDI score increases by <5.5 points from baseline.
Measured: 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 start25 Sep 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 Chronic Rhinosinusitis (CRS)Studies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 78 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
- NCT07386873
- Sponsor's protocol ID
- 9059107
- Status last verified
- Sep 2026
- First submitted
- 24 Jan 2026
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Position-Directed Budesonide Nasal Drops for Olfactory Dysfunction in Eosinophilic Chronic Rhinosinusitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07386873
- Acronym / sponsor ID
- 9059107
- Keywords
- Olfactory dysfunction, Chronic rhinosinusitis, Steroid nasal drops, Olfactory cleft obstruction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 25 Sep 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 single-center randomized controlled trial evaluates whether budesonide nasal drops delivered in the Wu's position (Wu's 45° Head-Hanging Reclination Position) improve olfactory function more effectively than conventional budesonide nasal spray in adults with type 2 chronic rhinosinusitis (CRS)-related olfactory dysfunction.
The study also evaluates patient-reported symptoms and quality of life, olfactory cleft structural abnormalities on sinus CT, computational fluid dynamics (CFD)-derived airflow parameters, safety, and whether baseline peripheral blood eosinophil count and clinical phenotype predict treatment response.
The main questions this clinical trial aims to answer are:
- Efficacy Comparison: Is olfactory improvement greater with olfactory cleft-targeted steroid nasal drops compared to standard nasal steroid sprays in CRS patients?
- Mechanism Exploration: How do changes in inflammatory markers, obstruction severity, and olfactory test results explain the potential benefits of this treatment approach?
- Disease Classification: Can post-treatment olfactory dysfunction be categorized as fully reversible, partially reversible, or non-responsive/irreversible using Week-12 TDI recovery?
Detailed description
Chronic rhinosinusitis (CRS)-related olfactory dysfunction may result from both obstruction of the olfactory cleft and persistent local inflammation. Conventional intranasal corticosteroid sprays may have limited and variable drug deposition in the olfactory cleft. This randomized controlled trial is designed to evaluate whether targeted delivery of budesonide nasal drops using the Wu's position (Wu's 45° Head-Hanging Reclination Position) provides greater olfactory improvement than conventional budesonide nasal spray in patients with eosinophilic/type 2 CRS-related olfactory dysfunction.
A total of 78 adults aged 18-65 years will be randomized 1:1 to receive either budesonide nasal drops administered in the Wu's position or conventional budesonide nasal spray for 12 weeks. Participants in the nasal-drop group will receive budesonide suspension, 20 drops per nostril twice daily, and will maintain the Wu's position for approximately 5 minutes after administration. Participants in the control group will receive conventional budesonide nasal spray, 2 actuations per nostril once daily in the upright sitting position.
Olfactory function will be assessed using Sniffin' Sticks, including odor threshold, discrimination, identification, and the composite TDI score. The primary outcome is the proportion of participants achieving a clinically meaningful TDI improvement of ≥5.5 points at Week 12. Additional assessments will include the Questionnaire of Olfactory Disorders-Negative Statements (QOD-NS), Olfactory-Visual Analogue Scale (VAS), the Sino-Nasal Outcome Test 22 (SNOT-22), Nasal Obstruction Symptom Evaluation (NOSE), and 4-item Concise Aging adults Smell Test (4-CAST). Sinus CT will be used to evaluate olfactory cleft structural abnormalities, while computational fluid dynamics (CFD) analysis will characterize olfactory cleft airflow.
At Week 12, olfactory recovery will also be classified as fully reversible, partially reversible, or non-responsive/irreversible according to the magnitude and completeness of TDI improvement. Baseline olfactory cleft CT findings, CFD-derived airflow parameters, peripheral blood eosinophil count, nasal polyp status, olfactory severity, and other clinical assessment scores will be explored as potential predictors of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal Drops Group | Experimental | Device: Nasal Drops |
| Standard Nasal Spray Group | Active comparator | Device: Nasal Spray |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women aged 18-65 years old.
- Diagnosis of CRS according to the EPOS 2020, with olfactory dysfunction lasting ≥ 12 weeks.
- Evidence of eosinophilic/type 2 inflammatory CRS, defined by at least one of the following: JESREC score ≥11, peripheral blood eosinophils ≥5%, absolute blood eosinophil count ≥ 0.25 × 10⁹/L.
- Confirmation of OD via Sniffin' Sticks test: TDI score <30.75 (hyposmia: 16 < TDI < 30.75; anosmia: TDI ≤ 16).
- Sinus CT scan confirming olfactory cleft abnormalities (e.g., mucosal thickening, polypoid changes, obstruction).
Key exclusion criteria (6 listed)
- Patients who have used systemic corticosteroids within the past 4 weeks or who have used intranasal corticosteroids within the past 2 weeks, or biologic therapy targeting type 2 inflammation within 6 months before enrolment.
- Patients with severe deviation of the nasal septum, nasal tumors, acute upper respiratory tract infection or uncontrolled allergic rhinitis.
- Patients with severe cardiovascular diseases, liver or kidney dysfunction, uncontrolled diabetes, or immune system disorders or other systemic disease that may interfere with study participation or safety.
- Patients with current pregnancy or plan to become pregnant during the study period.
- Patients with known hypersensitivity or contraindication to budesonide or any study medication component.
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 |
|---|---|---|
| Nasal DropsParticipants will receive budesonide suspension (2 mL:1 mg) as nasal drops, 20 drops per nostril twice daily (morning and evening) for 12 weeks. The drops will be administered in the Wu's position (Wu's 45° Head-Hanging Reclination Position), with the head suspended and tilted backward approximately 45° and the nostrils facing upward. The position will be maintained for approximately 5 minutes after instillation. | Device | Nasal Drops Group |
| Nasal SprayParticipants will administer conventional budesonide nasal spray in the standard upright sitting position according to routine clinical practice, 2 actuations per nostril once daily. Participants will be instructed to sniff gently after each spray. Treatment will continue for 12 weeks. | Device | Standard Nasal Spray Group |
Primary outcome
Proportion of Participants with Clinically Meaningful Improvement in the Sniffin' Sticks test
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
Proportion of participants achieving a clinically meaningful improvement in Sniffin' Sticks TDI score at Week 12. A responder is defined as a participant with an increase in the composite TDI score of ≥5.5 points from baseline. The TDI score is calculated as the sum of odor Threshold (T), Discrimination (D), and Identification (I) scores.
6 secondary outcomes
Subjective Olfactory Improvement and Nasal Symptoms
Time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
CT Evaluation of Olfactory Cleft Blockage
Time frame: Baseline , 4 weeks and 12 weeks after the initiation of treatment.
CFD Outcome
Time frame: Baseline, 4 weeks and 12 weeks after the initiation of treatment.
Inflammatory Marker Levels in Olfactory Mucosa
Time frame: Baseline and 4 weeks after the initiation of treatment.
Adverse Event
Time frame: 1 week, and 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.
Post-treatment Olfactory Reversibility Classification
Time frame: 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 16 Sep 2026.
- Individual participant dataSharing planned: No. We will decide whether to share the individual participant data after the study.
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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 Nasal Drops and Nasal Spray in people with Chronic Rhinosinusitis (CRS) and Olfactory 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 6 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 16 Sep 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. 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?
Proportion of Participants with Clinically Meaningful Improvement in the Sniffin' Sticks test (time frame: Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 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 16 Sep 2026.