Adults 18 to 85, any sex, with Chronic Rhinitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Mean Change of the Reflective Total Nasal Symptoms Score (rTNSS)Primary· Baseline and 3 months post study procedure
The rTNSS (Total Nasal Symptom Score) is a brief questionnaire developed to assess the severity of symptoms in individuals with rhinitis, particularly allergic rhinitis
The questionnaire consists of questions that evaluate the following 4 symptoms of Nasal Congestion, Runny Nose, Nasal Itching and Sneezing.
Each symptom is rated on a 4-point scale from "0" (no symptoms), "1" (mild symptoms), "2" (moderate symptoms" and "3" (severe symptoms). The total score is calculated by summing up the individual scores for each symptom.
The total score is the sum of the 4 nasal symptoms.
A low score in
Group
Value
95% CI
Treatment Arm
-4.2
-4.6 – -3.7
Participant Responder PercentageSecondary· Baseline and 3 months post study procedure
The rTNSS (Total Nasal Symptom Score) is a brief questionnaire developed to assess the severity of symptoms in individuals with rhinitis, particularly allergic rhinitis
The questionnaire consists of questions that evaluate the following symptoms of Nasal Congestion, Runny Nose, Nasal Itching and Sneezing.
Each symptom is rated on a 4-point scale from "0" (no symptoms) to "3" (severe symptoms). The total score is calculated by summing up the individual scores for each symptom.
The total score is the sum of the 4 nasal symptoms.
A low score indicates lower symptoms, a higher score indicates
Group
Value
95% CI
RhinAer ARC Stylus Treatment
76.2
68.1 – 82.8
3 Month - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)Secondary· Baseline and 3 months post study procedure
The Rhinoconjuctivitis Quality of Life Questionnaire is validated rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated for efficiency by reducing the number of questions to 14.
The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:
* 0 = not troubled
* 1 = hardly troubled at all
* 2 = somewhat troubled
* 3 = moderately troubled
* 4 = qu
Group
Value
95% CI
Treatment Arm
-1.8
-1.8 – -1.4
6 Months - Mean Change in Mini Rhinoconjuctivitis Quality of Life Questionnaire (Mini RQLQ)Secondary· 6 Months
The Rhinoconjuctivitis Quality of Life Questionnaire is a well-established, validated, and the most frequently used rhinoconjuctivitis disease-specific instrument. The MiniRQLQ, to be used in this study, was developed and validated to further facilitate ease of use and efficiency by reducing the number of questions to 14.
The instrument consists of 14 questions across 5 domains (activity limitations (n=3), practical problems (n=2), nose symptoms (n=3), eye symptoms (n=3), and other symptoms (n=3)). Responses are based on a 1-week recall and provided on a 7-point scale:
* 0 = not troubled
* 1
Group
Value
95% CI
Treatment Arm
1.17
± 1.0
Number of Participants With Device Related Adverse EventsSecondary· Baseline and 3 months post study procedure
Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period
Group
Value
95% CI
Treatment Arm
0
rTNSS Scores at 3 MonthsSecondary· 3 Months
The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
* 0 = absent symptoms (no sign/symptom is evident)
* 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
* 2 = moderate symptoms (definite a
Group
Value
95% CI
Treatment Arm
3.56
± 2.28
rTNSS Score at 6 MonthsSecondary· 6 Months
The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
* 0 = absent symptoms (no sign/symptom is evident)
* 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
* 2 = moderate symptoms (definite a
Group
Value
95% CI
Treatment Arm
2.85
± 2.24
rTNSS Change From Baseline at 6 Months Post ProcedureSecondary· 6 Months
The TNSS is an instrument used to collect patient self-rated severity of nasal symptoms originally comprised of 3 symptoms (nasal obstruction, itching/sneezing and secretion/runny nose) that has been widely adapted to include 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. The patient rates 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) on the following 4-point scale:
* 0 = absent symptoms (no sign/symptom is evident)
* 1 = mild symptoms (sign/symptom present, but minimal awareness; easily tolerated)
* 2 = moderate symptoms (definite a
Group
Value
95% CI
Treatment Arm
-4.90
± 2.92
Sponsor's own description
Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Aerin Medical
Last refreshed: 28 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04614324.