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This study aims to compare the efficacy of steroid nasal drops targeting the olfactory cleft versus traditional intranasal steroid sprays in improving olfactory function in patients with chronic rhinosinusitis (CRS) with olfactory cleft obstruction. The main questions this clinical trial aims to answer are:
Olfactory dysfunction is one of the most common clinical symptoms in patients with chronic rhinosinusitis (CRS), affecting approximately 60%-80% of individuals with CRS. This condition significantly impairs quality of life and is associated with systemic health issues such as depression and nutritional imbalances. The olfactory cleft, a critical anatomical region housing the olfactory neuroepithelium, is often obstructed in CRS patients due to nasal polyps or mucosal hypertrophy, leading to conductive olfactory dysfunction.
Current first-line treatments for CRS, including oral or intranasal corticosteroids, have limitations. Oral steroids pose systemic side effects, while standard nasal sprays often fail to deliver adequate drug concentrations to the olfactory cleft. In contrast, targeted hormone nasal drops may achieve higher efficacy by directly addressing localized inflammation and edema in the olfactory cleft. Preliminary studies suggest that fluticasone nasal drops can reduce the need for sinus surgery in patients with CRS unresponsive to conventional sprays. However, no randomized controlled trials have systematically evaluated the efficacy of olfactory cleft-targeted hormone drops in improving olfactory function in CRS patients with confirmed olfactory cleft obstruction.
In this study, investigators planned to enroll 54 patients with olfactory cleft obstruction and assign them to one of two treatments: olfactory cleft-targeted steroid nasal drops or conventional nasal sprays. This study aims to investigate the efficacy and underlying mechanisms of olfactory cleft-targeted steroid nasal drops in improving olfactory function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal Drops Group | Experimental |
| |
| Standard Nasal Spray Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal Drops | Device | Patients will assume the Mygind position (supine with head extended over the edge of the bed, nostrils facing upward). Five drops of budesonide suspension (2ml:1mg) will be administered into each nostril to ensure delivery to the olfactory cleft at the nasal apex. The position will be maintained for approximately 5 minutes, after which any residual medication in the oral or nasal cavity may be expelled. This procedure will be performed twice daily (morning and evening) for 3 months. During the first month, olfactory function will be assessed weekly, with a nasal sinus CT scan at the end of the month. In the second month, olfactory evaluations will be conducted biweekly, followed by a final assessment at the end of the third month. |
| Measure | Description | Time Frame |
|---|---|---|
| The Sniffin' Sticks test | A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI) | Baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Olfactory Improvement and Nasal Symptoms | Patient-reported olfactory improvement measured using the Olfactory-Visual Analogue Scale (VAS) and nasal symptoms assessed via the the Sino-Nasal Outcome Test 22 (SNOT-22) questionnaire. These measures evaluate treatment effects on self-perceived smell recovery and associated nasal complaints. | 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawei Wu, MD, PhD | Contact | 13522503401 | davidwuorl@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dawei Wu | Beijing | Beijing Municipality | 100191 | China |
We will decide whether to share the individual participant data after the study.
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| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Nasal Spray | Device | Patients will use budesonide nasal spray administered in the same Mygind position, with 2 sprays per nostril (total daily dose: 200μg). After administration, patients will gently sniff to facilitate drug dispersion. The treatment duration and follow-up schedule will be identical to the experimental group. |
|
| CT Evaluation of Olfactory Cleft Blockage | Baseline and 4 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. | 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. | 1 week, and 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks after the initiation of treatment. |
| D013568 | Pathological Conditions, Signs and Symptoms |