New nose drop study aims to bring back lost smell for sinusitis sufferers
NCT ID NCT07386873
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 2 times
Summary
This study compares two ways to give steroid medicine to people with chronic sinusitis who have lost their sense of smell due to blocked nasal passages. One group will get standard steroid spray, while the other gets steroid drops placed directly where smell happens. The goal is to see which method better improves smell and reduces symptoms. About 54 adults aged 18-65 with confirmed smell loss will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 78 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men and women aged 18-65 years old. 2. Diagnosis of CRS according to the EPOS 2020, with olfactory dysfunction lasting ≥ 12 weeks. 3. 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. 4. Confirmation of OD via Sniffin' Sticks test: TDI score \<30.75 (hyposmia: 16 \< TDI \< 30.75; anosmia: TDI ≤ 16). 5. Sinus CT scan confirming olfactory cleft abnormalities (e.g., mucosal thickening, polypoid changes, obstruction). 6. Willingness to participate in this study and sign the informed consent form (ICF). Exclusion Criteria: 1. 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. 2. Patients with severe deviation of the nasal septum, nasal tumors, acute upper respiratory tract infection or uncontrolled allergic rhinitis. 3. 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. 4. Patients with current pregnancy or plan to become pregnant during the study period. 5. Patients with known hypersensitivity or contraindication to budesonide or any study medication component. 6. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Dawei Wu
Beijing, Beijing Municipality, 100191, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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