Position-Directed Budesonide Nasal Drops for CRS-associated Olfactory Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPeking University Third Hospital
About this 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.
The main questions this clinical trial aims to answer are:
1. Efficacy Comparison: Is olfactory improvement greater with olfactory cleft-targeted steroid nasal drops compared to standard nasal steroid sprays in CRS patients? 2. Mechanism Exploration: How do changes in inflammatory markers, obstruction severity, and olfactory test results explain the potential benefits of this treatment approach? 3. Disease Classification: Can post-treatment olfactory dysfunction be categorized as fully reversible, partially reversible, or non-responsive/irreversible using Week-12 TDI recovery?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Nasal Drops
DeviceParticipants 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 Spray
DeviceParticipants 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.
Treatment groups
78 Participants
are divided into 2 treatment groupsGroup A: Nasal Drops GroupExperimental treatment 1 intervention
Group B: Standard Nasal Spray GroupActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.Secondary outcomes
1
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.
Time frame
Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment.2
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.
Time frame
Baseline , 4 weeks and 12 weeks after the initiation of treatment.3
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.
Time frame
Baseline, 4 weeks and 12 weeks after the initiation of treatment.4
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.
Time frame
Baseline and 4 weeks after the initiation of treatment.Sponsors and contacts
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Source ClinicalTrials.gov
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