Chronic RhinitisNCT05648565
Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis
A study testing Radiofrequency ablation (RFA) in people with Chronic Rhinitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to assess the effectiveness of radiofrequency ablation (RFA) of the posterior nasal nerve (PNN) in chronic rhinitis (CR) patients by comparing patient reflective total nasal symptom score (rTNSS) and nasal obstruction symptom evaluation (NOSE) , peak nasal inspiratory flow (PNIF) , and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- Radiofrequency ablation (RFA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2023to 20 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic rhinitis symptoms for at least 6 months (rhinorrhea, congestion, post-nasal drip)
- poor response to medical management that was attempted for at least 4 weeks
- a rTNSS score ≥6, as well as ≥2 for rhinorrhea, and ≥1 for congestion.
Who cannot join
- active sinusitis
- rhinitis medicamentosa
- recurrent and ongoing epistaxis
- immunodeficiency as defined by an illness or a history of sinus surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to assess the effectiveness of radiofrequency ablation (RFA) of the posterior nasal nerve (PNN) in chronic rhinitis (CR) patients by comparing patient reflective total nasal symptom score (rTNSS) and nasal obstruction symptom evaluation (NOSE) , peak nasal inspiratory flow (PNIF) , and levels of Type 2 cytokines pre- and post-procedure.
- Conditions
- Chronic Rhinitis
- Being tested
- Radiofrequency ablation (RFA)
- Keywords
- radiofrequency ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation (RFA)Device
The NEUROMARK device is an in-office, disposable bipolar RFA device with a treatment tip consisting of micro electrodes which delivers RF energy while monitoring appropriate tissue contact to maximize delivery to posterior nasal nerve and its variable branching. After topical anesthesia consisting of oxymetazoline and 1% lido followed by 4% lidocaine, the device will be placed in the posterior inferior turbinate under endoscopic visualization. The device will be activated per manufacturer's instructions
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency ablation (RFA) | Experimental | Not described Receives: Device: Radiofrequency ablation (RFA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute.
Measured: Baseline
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute
Measured: 4 weeks post intervention
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute
Measured: 12 weeks post intervention
Interleukin-10 (IL-10)
cytokine
Measured: Baseline
Interleukin-22 (IL-22)
cytokine
Measured: Baseline
Interleukin-10 (IL-10)
cytokine
Measured: 12 weeks post intervention
Interleukin-22 (IL-22)
cytokine
Measured: 12 weeks post intervention
Secondary outcomes (6)
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)
This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion
Measured: Baseline
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)
This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion
Measured: 4 weeks post intervention
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)
This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion
Measured: 12 weeks post intervention
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)
This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.
Measured: Baseline
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)
This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.
Measured: 4 weeks post intervention
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)
This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.
Measured: 12 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start10 Jan 2023
- Primary completion20 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Otolaryngic Allergy
- Responsible party
- Principal investigator, David Z. Allen, The University of Texas Health Science Center, Houston
- Investigators
- David Z Allen, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648565
- Sponsor's protocol ID
- HSC-MS-22-0899
- Status last verified
- Mar 2025
- First submitted
- 5 Dec 2022
- Last updated
- 3 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT05648565
- Acronym / sponsor ID
- HSC-MS-22-0899
- Conditions
- Chronic Rhinitis
- Keywords
- radiofrequency ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- American Academy of Otolaryngic Allergy
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 13 Dec 2022 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effectiveness of radiofrequency ablation (RFA) of the posterior nasal nerve (PNN) in chronic rhinitis (CR) patients by comparing patient reflective total nasal symptom score (rTNSS) and nasal obstruction symptom evaluation (NOSE) , peak nasal inspiratory flow (PNIF) , and levels of Type 2 cytokines pre- and post-procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency ablation (RFA) | Experimental | Device: Radiofrequency ablation (RFA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- chronic rhinitis symptoms for at least 6 months (rhinorrhea, congestion, post-nasal drip)
- poor response to medical management that was attempted for at least 4 weeks
- a rTNSS score ≥6, as well as ≥2 for rhinorrhea, and ≥1 for congestion.
Key exclusion criteria (4 listed)
- active sinusitis
- rhinitis medicamentosa
- recurrent and ongoing epistaxis
- immunodeficiency as defined by an illness or a history of sinus surgery.
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 |
|---|---|---|
| Radiofrequency ablation (RFA)The NEUROMARK device is an in-office, disposable bipolar RFA device with a treatment tip consisting of micro electrodes which delivers RF energy while monitoring appropriate tissue contact to maximize delivery to posterior nasal nerve and its variable branching. After topical anesthesia consisting of oxymetazoline and 1% lido followed by 4% lidocaine, the device will be placed in the posterior inferior turbinate under endoscopic visualization. The device will be activated per manufacturer's instructions | Device | Radiofrequency ablation (RFA) |
Primary outcome
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
Time frame: Baseline
PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute.
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
Time frame: 4 weeks post intervention
PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
Time frame: 12 weeks post intervention
PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute
Interleukin-10 (IL-10)
Time frame: Baseline
cytokine
Interleukin-22 (IL-22)
Time frame: Baseline
cytokine
Interleukin-10 (IL-10)
Time frame: 12 weeks post intervention
cytokine
Interleukin-22 (IL-22)
Time frame: 12 weeks post intervention
cytokine
6 secondary outcomes
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)
Time frame: Baseline
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)
Time frame: 4 weeks post intervention
Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)
Time frame: 12 weeks post intervention
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)
Time frame: Baseline
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)
Time frame: 4 weeks post intervention
Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)
Time frame: 12 weeks post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David Z Allen, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation (RFA) in people with Chronic Rhinitis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 3 Apr 2025. 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) (time frame: Baseline). The study lists 7 primary outcomes in all. 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 3 Apr 2025.