Clinical trial NCT05648565: Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinitis
Keywords: radiofrequency ablation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: American Academy of Otolaryngic Allergy
First posted: 2022-12-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
timeFrame: Baseline
measure: Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
timeFrame: 4 weeks post intervention
measure: Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)
timeFrame: 12 weeks post intervention
measure: Interleukin-10 (IL-10)
timeFrame: Baseline
measure: Interleukin-22 (IL-22)
timeFrame: Baseline
measure: Interleukin-10 (IL-10)
timeFrame: 12 weeks post intervention
measure: Interleukin-22 (IL-22)
timeFrame: 12 weeks post intervention
Secondary outcomes:
measure: Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: Baseline
measure: Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 4 weeks post intervention
measure: Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: 12 weeks post intervention
measure: Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)
timeFrame: Baseline
measure: Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)
timeFrame: 4 weeks post intervention
measure: Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)
timeFrame: 12 weeks post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: David Z Allen, MD
role: PRINCIPAL_INVESTIGATOR
References: