Position-Directed Budesonide Nasal Drops for CRS-associated Olfactory Dysfunction

NCT07386873 | Not Yet Recruiting DMC

• 1 other identifier: 9059107
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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 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:

1. 1.Efficacy Comparison: Is olfactory improvement greater with olfactory cleft-targeted steroid nasal drops compared to standard nasal steroid sprays in CRS patients?
2. 2.Mechanism Exploration: How do changes in inflammatory markers, obstruction severity, and olfactory test results explain the potential benefits of this treatment approach?
3. 3.Disease Classification: Can post-treatment olfactory dysfunction be categorized as fully reversible, partially reversible, or non-responsive/irreversible using Week-12 TDI recovery?

Conditions

Olfactory Dysfunction; Chronic Rhinosinusitis (CRS)

Keywords

Olfactory dysfunction; Chronic rhinosinusitis; Steroid nasal drops; Olfactory cleft obstruction

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  Baseline , 4 weeks and 12 weeks after the initiation of treatment.

• CFD Outcome

  Baseline, 4 weeks and 12 weeks after the initiation of treatment.

• Inflammatory Marker Levels in Olfactory Mucosa

  Baseline and 4 weeks after the initiation of treatment.

• Adverse Event

  1 week, and 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.

Study Arms (2)

Nasal Drops Group

EXPERIMENTAL

Device: Nasal Drops

Standard Nasal Spray Group

ACTIVE COMPARATOR

Device: Nasal Spray

Interventions

Nasal Drops DEVICE

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 Drops Group

Nasal Spray DEVICE

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.

Standard Nasal Spray Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Dawei Wu

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Dawei Wu, MD, PhD

CONTACT

13522503401; davidwuorl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 4, 2026
• Study Start: September 25, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)