Clinical trial NCT04533438: RhinAer Procedure for Treatment of Chronic Rhinitis Study
Official title: The RhinAer Procedure for Treatment of CHronic RhInitis - A Prospective, MulticeNter Randomized ConTrolled TRial Comparing RhinAer to Sham Control (RHINTRAC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinitis
Lead sponsor: Aerin Medical
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 2:1 site-stratified randomization will be used to allocate participants to either the RhinAer procedure or treatment with the sham (control) procedure. Crossover within 30 days after 3- or 6-month follow-up visit.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.

Detailed description: The purpose of this study is to compare the RhinAer procedure to treat tissue in the posterior nasal nerve area to improve symptoms in adults diagnosed with chronic rhinitis with a sham procedure that duplicates the actual procedure as closely as possible absent the delivery of radiofrequency (RF) energy to the nasal tissue.

Eligibility criteria: Inclusion Criteria:

1. Age 18 to 85 years (inclusively).
2. Willing and able to provide informed consent.
3. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
4. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure.
5. Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea).
6. Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion).
7. rTNSS ≥ 6.

Exclusion Criteria:

1. Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
2. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
3. Active nasal or sinus infection.
4. History of significant dry eye.
5. History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation.
6. Have rhinitis symptoms only on a seasonal basis due to allergies.
7. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
8. Known or suspected to be pregnant or is lactating.
9. Participating in another clinical research study.
10. Has any condition that predisposes to excessive bleeding.
11. Is taking anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure.
12. Has previous procedure or surgery for chronic rhinitis.
13. Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.

Primary outcomes:
measure: Reflective Total Nasal Symptom Score (rTNSS) Responder Rate
timeFrame: 3 months visit following the study procedure.
Secondary outcomes:
measure: Reflective Total Nasal Symptom Score (rTNSS) Mean Change
timeFrame: Change from Baseline to 3 months following the study procedure.
measure: Reflective Total Nasal Symptom Score (rTNSS) Mean Change
timeFrame: Change from Baseline to 12 months following the study procedure.
measure: Percentage of Participants With Treatment Related Events (Safety)
timeFrame: At or following the study procedure up to to 3 months.
Other outcomes:
measure: Nasal Status Assessment
timeFrame: Baseline, 1 month, 3 months and 6 months following the study procedure
Locations:
city: Roseville
country: United States
facility: Sacramento ENT (DaVinci Research)
state: California
city: Torrance
country: United States
facility: Breathe Clear Institute
state: California
city: Plantation
country: United States
facility: ENT and Allergy Associates of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Piedmont ENT
state: Georgia
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: New York
country: United States
facility: Madison ENT
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati College of Medicine
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt Asthma, Sinus & Allergy Program
state: Tennessee
city: Fort Worth
country: United States
facility: Texas Healthcare
state: Texas
city: Fredericksburg
country: United States
facility: Fredericksburg ENT
state: Texas
city: McKinney
country: United States
facility: ENT Associates of Texas (ENTtex)
state: Texas
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
Study officials:
affiliation: ENT of Georgia North
name: Pablo Stolovitzky, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Sinus Center at Houston Methodist Hospital
name: Mas Takashima, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD, Takashima M. Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial. OTO Open. 2021 Sep 10;5(3):2473974X211041124. doi: 10.1177/2473974X211041124. eCollection 2021 Jul-Sep.
citation: Takashima M, Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. 2023 Feb;13(2):107-115. doi: 10.1002/alr.23047. Epub 2022 Jul 5.
citation: Takashima M, Stolovitzky JP, Ow RA, Silvers SL, McDuffie CM, Dean M, Sedaghat AR, Tajudeen BA. Temperature-controlled radiofrequency ablation for the treatment of chronic rhinitis: Two-year outcomes from a prospective multicenter trial. Int Forum Allergy Rhinol. 2024 Jul;14(7):1182-1194. doi: 10.1002/alr.23315. Epub 2024 Jan 24.
citation: Stolovitzky JP, Ow RA, Silvers SL, Tajudeen BA, McDuffie CM, Dean M, Sedaghat AR, Phillips K, Takashima M. 3-Year Outcomes of Temperature-Controlled Radiofrequency Ablation of the Posterior Nasal Nerve in Patients With Chronic Rhinitis. Int Forum Allergy Rhinol. 2025 Apr 4:e23577. doi: 10.1002/alr.23577. Online ahead of print.