Trial Outcomes & Findings for A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF) (NCT NCT04614324)

Recruitment for this trial occurred between 10/5/2020 and 5/12/21. This prospective single-arm study enrolled patients across 16 centers in the United States (13) and Germany (3). All sites were either medical clinics or academic medical centers.

There was no wash out or run in for this study

A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF)

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 indicates lower symptoms, a higher score indicates more symptoms. Range of score is 0-12 This questionnaire was provided to subjects at baseline and again at 3 months post procedure. This outcome measure shows the difference in overall scores. The average change in the score between baseline and 3M

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 more symptoms. This questionnaire was provided to subjects at baseline and again at 3 months post procedure. This outcome measure shows the percentage of participants who responded to the procedure with improved rTNSS score

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 = quite a bit troubled * 5 = very troubled * 6 = extremely troubled. The total or overall MiniRQLQ score is the mean of the 14 responses (range of 0-6). Developers of the original RQLQ reported MCID for overall miniRQLQ \>0.7 with another study indicating 0.42 (95% CI 0.30-0.51).

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 = hardly troubled at all * 2 = somewhat troubled * 3 = moderately troubled * 4 = quite a bit troubled * 5 = very troubled * 6 = extremely troubled. The total or overall MiniRQLQ score is the mean of the 14 responses range (0-6).

Evaluate profile by characterizing the type and frequency of adverse events reported at or following the study procedure an throughout the follow up period

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 awareness of sign/symptom that is bothersome but tolerable) * 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12 A low score indicates lower symptoms, a higher score indicates more symptoms.

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 awareness of sign/symptom that is bothersome but tolerable) * 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12 A low score indicates lower symptoms, a higher score indicates more symptoms.

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 awareness of sign/symptom that is bothersome but tolerable) * 3 = severe symptoms (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping). The total score is the sum of the 4 nasal symptoms. Range of Scores 0-12 A low score indicates lower symptoms, a higher score indicates more symptoms.