Chronic Rhinitis
Conditions
Keywords
radiofrequency ablation
Brief 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 levels of Type 2 cytokines pre- and post-procedure.
Interventions
DEVICERadiofrequency 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
Sponsors
American Academy of Otolaryngic Allergy
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* active sinusitis * rhinitis medicamentosa * recurrent and ongoing epistaxis * immunodeficiency as defined by an illness or a history of sinus surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | Baseline | PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute. |
| Interleukin-10 (IL-10) | Baseline | cytokine |
| Interleukin-22 (IL-22) | Baseline | cytokine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) | Baseline | 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 |
| Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Radiofrequency Ablation (RFA) 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 | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Radiofrequency Ablation (RFA) | — |
|---|---|---|
| Age, Continuous | 62.18 years STANDARD_DEVIATION 14.6 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 17 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 3 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Interleukin-10 (IL-10)
cytokine
Time frame: 12 weeks post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency Ablation (RFA) | Interleukin-10 (IL-10) | 9.05 picogram per milliliter (pg/mL) | Standard Deviation 38.06 |
Primary
Interleukin-10 (IL-10)
cytokine
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency Ablation (RFA) | Interleukin-10 (IL-10) | 1.63 picogram per milliliter (pg/mL) | Standard Deviation 4.28 |
Primary
Interleukin-22 (IL-22)
cytokine
Time frame: 12 weeks post intervention
Population: cytokine
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency Ablation (RFA) | Interleukin-22 (IL-22) | 0.37 picogram per milliliter (pg/mL) | Standard Deviation 3.13 |
Primary
Interleukin-22 (IL-22)
cytokine
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Radiofrequency Ablation (RFA) | Interleukin-22 (IL-22) | 0.45 picogram per milliliter (pg/mL) | Standard Deviation 1.22 |
Primary
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation (RFA) | Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | 90 Liters Per Minute |
Primary
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
Time frame: 4 weeks post intervention
Population: Data were not collected from 6 participants in the Radiofrequency ablation (RFA) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation (RFA) | Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | 85 Liters Per Minute |
Primary
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
Time frame: 12 weeks post intervention
Population: Data were not collected from 5 participants in the Radiofrequency ablation (RFA) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation (RFA) | Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF) | 85 Liters Per Minute |
Secondary
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
Time frame: 4 weeks post intervention
Population: Data were not collected from 6 participants in the Radiofrequency ablation (RFA) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation (RFA) | Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) | 4 score on a scale |
Secondary
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
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation (RFA) | Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) | 7 score on a scale |
Secondary
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
Time frame: 12 weeks post intervention
Population: Data were not collected from 5 participants in the Radiofrequency ablation (RFA) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation (RFA) | Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS) | 4 score on a scale |
Secondary
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.
Time frame: 4 weeks post intervention
Population: Data were not collected from 6 participants in the Radiofrequency ablation (RFA) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation (RFA) | Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | 10 score on a scale |
Secondary
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.
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation (RFA) | Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | 50 score on a scale |
Secondary
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.
Time frame: 12 weeks post intervention
Population: Data were not collected from 5 participants in the Radiofrequency ablation (RFA) arm.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiofrequency Ablation (RFA) | Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE) | 17.5 score on a scale |