Rhinitis, AllergicPhase 1NCT05724290
Mechanism of EGR2 in Allergic Rhinitis
A Phase 1 study testing EGR2 in people with Rhinitis, Allergic, run by Zu-xia Ma at 1 site in China.
Trial summary
EGR2 may be a target for the treatment of nasal polyps. Read more about this study
- Who is it for?
- Ages 16 to 76 years
- Conditions the study is for
- Rhinitis, Allergic
- What is being tested?
- EGR2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2023to 5 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 16 to 76 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients were stopped by systemic or topical corticosteroid treatment at least one month before the study.
Who cannot join
- Patients had NPs accompanied by choanal polyps, fungal nasal sinusitis, cystic fibrosis, acute upper airway upper infection or other systemic diseases.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Central Laboratory of the Third Affiliated Hospital of ZunYi Medical University
Zunyi, 563003
About this study
Official title: The Regulatory Mechanism of EGR2 Mediated by miR-150-5p on Allergic Rhinitis
EGR2 may be a target for the treatment of nasal polyps.
Read the detailed description
There is much debate about the etiology of nasal polyps, so the pathogenesis of nasal polyps still needs to be clarified. Surgery for noninflammatory nasal polyps may be better control, but surgery is not effective for recurrent sinusitis and nasal polyps. Therefore, more research is needed to determine the best targeted therapy for nasal polyps. We found that EGR2 expression was upregulated in CRSwNP patients with allergic rhinitis.In addition, the expression of EGR2 in CRSwNP mucosa was significantly higher than that in the control group, and the expression of EGR2 in CRSwNP with allergic rhinitis was higher than that in CRSwNP without allergic rhinitis. EGR2 may be involved in the pathogenesis of nasal polyps, and may also be related to the severity and recurrence of nasal polyps. EGR2 may be a target for the treatment of nasal polyps.
- Conditions
- Rhinitis, Allergic
- Being tested
- EGR2
- Keywords
- nasal polyps, chronic rhinosinusitis, atopic NPs, non-atopic NPs, EGR2
- Medical subject headings
- Rhinitis, Allergic, Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGR2Genetic
We investigated the expression of EGR2 in patients with nasal polyps through immunohistochemistry.
| Study group | Role | What they receive |
|---|---|---|
| immunohistochemistry | Experimental | Thirty-eight patients with confirmed nasal polyps (20 with primary CRSwNP and allergic rhinitis (AR) and 18 with CRSWNP) and 20 patients with chronic hypertrophic rhinitis were included. The nasal polyps and mucosal specimens of all patients were collected and analyzed by immunohistochemistry Receives: Genetic: EGR2 |
| WestBlot | Experimental | Thirty-eight patients with confirmed nasal polyps (20 with primary CRSwNP and allergic rhinitis (AR) and 18 with CRSWNP) and 20 patients with chronic hypertrophic rhinitis were included. The nasal polyps and mucosal specimens of all patients were collected and analyzed by Western Blot. Receives: Genetic: EGR2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
expression of EGR2
expression of EGR2 were analyzed by immunohistochemistry and Western Blot
Measured: one months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start30 Jan 2023
- Primary completion1 Feb 2023
- Study completion5 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhinitis, AllergicStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zu-xia Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zu-xia Ma, Zunyi Medical College
- Investigators
- Yong Luo, Doctor, Principal investigator, Zunyi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724290
- Sponsor's protocol ID
- [2018]1182
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Regulatory Mechanism of EGR2 Mediated by miR-150-5p on Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT05724290
- Acronym / sponsor ID
- [2018]1182
- Conditions
- Rhinitis, Allergic
- Keywords
- nasal polyps, chronic rhinosinusitis, atopic NPs, non-atopic NPs, EGR2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Zu-xia MaUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 5 May 2023 (estimated)
- First posted
- 13 Feb 2023 (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.
EGR2 may be a target for the treatment of nasal polyps.
Detailed description
There is much debate about the etiology of nasal polyps, so the pathogenesis of nasal polyps still needs to be clarified. Surgery for noninflammatory nasal polyps may be better control, but surgery is not effective for recurrent sinusitis and nasal polyps. Therefore, more research is needed to determine the best targeted therapy for nasal polyps. We found that EGR2 expression was upregulated in CRSwNP patients with allergic rhinitis.In addition, the expression of EGR2 in CRSwNP mucosa was significantly higher than that in the control group, and the expression of EGR2 in CRSwNP with allergic rhinitis was higher than that in CRSwNP without allergic rhinitis. EGR2 may be involved in the pathogenesis of nasal polyps, and may also be related to the severity and recurrence of nasal polyps. EGR2 may be a target for the treatment of nasal polyps.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immunohistochemistry | Experimental | Genetic: EGR2Thirty-eight patients with confirmed nasal polyps (20 with primary CRSwNP and allergic rhinitis (AR) and 18 with CRSWNP) and 20 patients with chronic hypertrophic rhinitis were included. The nasal polyps and mucosal specimens of all patients were collected and analyzed by immunohistochemistry |
| WestBlot | Experimental | Genetic: EGR2Thirty-eight patients with confirmed nasal polyps (20 with primary CRSwNP and allergic rhinitis (AR) and 18 with CRSWNP) and 20 patients with chronic hypertrophic rhinitis were included. The nasal polyps and mucosal specimens of all patients were collected and analyzed by Western Blot. |
Who may qualify
- Ages
- 16 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients were stopped by systemic or topical corticosteroid treatment at least one month before the study.
Key exclusion criteria (1 listed)
- Patients had NPs accompanied by choanal polyps, fungal nasal sinusitis, cystic fibrosis, acute upper airway upper infection or other systemic diseases.
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 |
|---|---|---|
| EGR2We investigated the expression of EGR2 in patients with nasal polyps through immunohistochemistry. | Genetic | WestBlot, immunohistochemistry |
Primary outcome
expression of EGR2
Time frame: one months
expression of EGR2 were analyzed by immunohistochemistry and Western Blot
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yong Luo, Doctor principal investigator
Zunyi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EGR2 in people with Rhinitis, Allergic, run by Zu-xia Ma 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
expression of EGR2 (time frame: one months). 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 13 Feb 2023.