Chronic Rhinitis
Conditions
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.
Interventions
DEVICERhinAer Stylus
The RhinAer procedure will be performed in the study clinic using the RhinAer Stylus and Aerin Console. The RhinAer Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior turbinate) in both nostrils treated during a single study procedure session.
DEVICESham
The control treatment will be performed in the study clinic using the RhinAer Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
Sponsors
Aerin Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will be blinded to the study arm they are assigned to.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reflective Total Nasal Symptom Score (rTNSS) Responder Rate | 3 months visit following the study procedure. | TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. 4 Symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) are reported with score of 0/absent; 1/mild; 2/moderate; 3/severe. The total score is the sum of the 4 nasal symptom scores with a maximum TNSS of 12 indicating the most severe symptoms. Treatment Responder based on rTNSS improvement Individual participant success (responder) is defined as at least 30% improvement (decrease) in the rTNSS from baseline. For this protocol patients had to meet inclusion criteria of rTNSS rating of 2 or 3 for Rhinorrhea; rTNSS rating of 1, 2 or 3 for Congestion; and total rTNSS score \>/= 6 at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reflective Total Nasal Symptom Score (rTNSS) Mean Change | Change from Baseline to 3 months following the study procedure. | The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. This study will measure the mean change in rTNSS from baseline to 3 months after the procedure. |
| Percentage of Participants With Treatment Related Events (Safety) | At or following the study procedure up to to 3 months. | Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, severity, duration and outcome will be documented. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nasal Status Assessment | Baseline, 1 month, 3 months and 6 months following the study procedure | The Nasal Status Assessment is an evaluation, performed by a physician, of 10 specified physical or intranasal findings. Each finding is ranked in severity from Not Present to Severe. Each component of the assessment will be summarized. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at X academic medical centers and clinics between July 30, 2020 and December 29, 2020. The first participant was enrolled on July 31, 2020 and the last participant was enrolled in December 28,2020
Pre-assignment details
There was no wash out or run in for this study
Participants by arm
| Arm | Count |
|---|---|
| Active Treatment Subjects randomized to receive the Rhinaer procedure | 77 |
| Sham Control Subjects randomized to receive the Sham Procedure | 39 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Crossover Period | Did not meet Eligibility to Crossover | 0 | 11 |
Baseline characteristics
| Characteristic | Active Treatment | Total | Sham Control |
|---|---|---|---|
| Age, Continuous | 57.3 years STANDARD_DEVIATION 14.8 | 57.5 years STANDARD_DEVIATION 14.6 | 57.8 years STANDARD_DEVIATION 14.4 |
| Medication Use - Antihistamines | 56 Participants | 84 Participants | 28 Participants |
| Medication Use - Decongestants | 22 Participants | 32 Participants | 10 Participants |
| Medication Use -Intranasal anticholinergic sprays | 19 Participants | 27 Participants | 8 Participants |
| Medication use - Intranasal steroid sprays | 34 Participants | 60 Participants | 26 Participants |
| Medication Use - Oral leukotriene inhibitors | 4 Participants | 7 Participants | 3 Participants |
| Nasal Exam Nasal Polyps | 3 Participants | 3 Participants | 0 Participants |
| Nasal Exam Turbinate Enlargement | 16 Participants | 24 Participants | 8 Participants |
| Prior Nasal Surgery | 27 Participants | 40 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 6 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 105 Participants | 36 Participants |
| rTNSS | 8.3 rTNSS Score STANDARD_DEVIATION 1.9 | 8.25 rTNSS Score STANDARD_DEVIATION 1.85 | 8.2 rTNSS Score STANDARD_DEVIATION 1.8 |
| Sex: Female, Male Female | 49 Participants | 75 Participants | 26 Participants |
| Sex: Female, Male Male | 28 Participants | 41 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 39 |
| other Total, other adverse events | 7 / 77 | 1 / 39 |
| serious Total, serious adverse events | 0 / 77 | 0 / 39 |
Outcome results
Primary
Reflective Total Nasal Symptom Score (rTNSS) Responder Rate
TNSS is an instrument used to collect patient self-rated severity of nasal symptoms. 4 Symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing) are reported with score of 0/absent; 1/mild; 2/moderate; 3/severe. The total score is the sum of the 4 nasal symptom scores with a maximum TNSS of 12 indicating the most severe symptoms. Treatment Responder based on rTNSS improvement Individual participant success (responder) is defined as at least 30% improvement (decrease) in the rTNSS from baseline. For this protocol patients had to meet inclusion criteria of rTNSS rating of 2 or 3 for Rhinorrhea; rTNSS rating of 1, 2 or 3 for Congestion; and total rTNSS score \>/= 6 at baseline
Time frame: 3 months visit following the study procedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active Treatment | Reflective Total Nasal Symptom Score (rTNSS) Responder Rate | 52 Participants |
| Sham Control | Reflective Total Nasal Symptom Score (rTNSS) Responder Rate | 16 Participants |
Secondary
Percentage of Participants With Treatment Related Events (Safety)
Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, severity, duration and outcome will be documented.
Time frame: At or following the study procedure up to to 3 months.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Active Treatment | Percentage of Participants With Treatment Related Events (Safety) | Severe Nasal Soreness/Pain | 1 Participants |
| Active Treatment | Percentage of Participants With Treatment Related Events (Safety) | Increased Nasal Congestion at 1 month | 1 Participants |
| Active Treatment | Percentage of Participants With Treatment Related Events (Safety) | Mild nasal bleeding immediate post procedure | 0 Participants |
| Sham Control | Percentage of Participants With Treatment Related Events (Safety) | Severe Nasal Soreness/Pain | 0 Participants |
| Sham Control | Percentage of Participants With Treatment Related Events (Safety) | Increased Nasal Congestion at 1 month | 0 Participants |
| Sham Control | Percentage of Participants With Treatment Related Events (Safety) | Mild nasal bleeding immediate post procedure | 1 Participants |
Secondary
Reflective Total Nasal Symptom Score (rTNSS) Mean Change
The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. This study will measure the mean change in rTNSS from baseline to 3 months after the procedure.
Time frame: Change from Baseline to 3 months following the study procedure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment | Reflective Total Nasal Symptom Score (rTNSS) Mean Change | -3.6 score on a scale |
| Sham Control | Reflective Total Nasal Symptom Score (rTNSS) Mean Change | -2.2 score on a scale |
Secondary
Reflective Total Nasal Symptom Score (rTNSS) Mean Change
The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity.
Time frame: Change from Baseline to 12 months following the study procedure.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Active Treatment | Reflective Total Nasal Symptom Score (rTNSS) Mean Change | -4.8 score on a scale |
Other Pre-specified
Nasal Status Assessment
The Nasal Status Assessment is an evaluation, performed by a physician, of 10 specified physical or intranasal findings. Each finding is ranked in severity from Not Present to Severe. Each component of the assessment will be summarized.
Time frame: Baseline, 1 month, 3 months and 6 months following the study procedure
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Active Treatment | Nasal Status Assessment | Significant Dry Eye | 1 participants |
| Active Treatment | Nasal Status Assessment | Soreness, Pain | 3 participants |
| Sham Control | Nasal Status Assessment | Significant Dry Eye | 0 participants |
| Sham Control | Nasal Status Assessment | Soreness, Pain | 4 participants |