Nasal Breathing, Nasal Valve Collapse
Conditions
Keywords
nasal airway obstruction, sham-control, Polylactide absorbable implant
Brief summary
The primary objective of the LATERA RCT is to demonstrate the superiority of the Latera Implant to improve nasal breathing, compared with a Sham Control procedure.
Detailed description
To evaluate the Latera Absorbable Nasal Implant (Latera Implant) Implant versus Sham Control in subjects with nasal valve collapse due to or primarily due to insufficient cartilaginous support of the lateral nasal wall.
Interventions
DEVICELatera Implant
Treatment with implant
DEVICESham Procedure
Sham procedure where the Latera delivery device is inserted but no implant delivered.
Sponsors
New Arch Consulting
Spirox, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants will be masked to treatment assignment through the 3-month assessment period.
Intervention model description
Sham procedure participants will be allowed to crossover to receive Latera implants after the 3-month assessment if they continue to meet eligibility criteria. Crossover participants will be followed through 24 months post implant. Sham participants who do not crossover will be exited after the 3-month assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects must meet the following criteria to be included in the study: 1. Adults aged 18 and above; 2. Understands and provides written informed consent; 3. Stated willingness to comply with all study procedures, post-treatment care and availability for the duration of the study follow up of 2 years; 4. In good general health as evidenced by medical history; 5. NOSE score ≥55; 6. Dynamic bi-lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver; 7. Nasal and facial anatomy appropriate to receive the Latera Implant; 8. Documented failure of benefit after at least 4 weeks of conservative medical management, including, for example, antihistamines or nasal steroids, evidenced by lack of efficacy or tolerability. Subjects meeting any one of the following criteria will be excluded for the study: 1. Unable to tolerate or not a candidate for procedures performed under local anesthesia; 2. Pathology other than lateral wall insufficiency (e.g. septal deviation, turbinate or adenoid hypertrophy, polyps, sinusitis, rhinitis) is the primary contributor to airway obstruction; 3. Requires or is anticipated to require any other concurrent nasal procedures (e.g. Functional Endoscopic Sinus Surgery (FESS), rhinoplasty, sinuplasty, septoplasty, or turbinate reduction) outside of the index procedure within 12 months after the index procedure; 4. FESS, sinuplasty, septoplasty, inferior turbinate reduction, or rhinoplasty within the past 6 months; 5. Any other rhinoplasty procedures are planned or planned usage of external dilators within 24 months after the index procedure; 6. Permanent nasal implant of any type (e.g. autologous, homologous, or synthetic graft) or dilator; 7. Presence of concomitant inflammatory or infectious conditions or unhealed wounds in the treatment area (e.g., vestibulitis, vasculitis, active acne), 8. Currently using chronic systemic steroids or recreational intra-nasal drugs; 9. Currently has cancerous or pre-cancerous nasal lesions, has had radiation in the treatment area, or is currently receiving chemotherapy; 10. History of a significant healing disorders including hypertrophic scarring, or keloid formation; 11. Poorly controlled diabetes mellitus; 12. Known or suspected allergy to PLA or other absorbable implant materials in the Latera Implant; 13. Severe obstructive sleep apnea (OSA) and cannot or is unwilling to refrain from continuous positive airway pressure (CPAP) for up to 2 weeks post-procedure based on expected healing needs and mask types, in agreement with the treating physician; 14. Female subjects, of child bearing potential, known or suspected to be pregnant or are lactating; 15. Any other presenting condition that, in the medical opinion of the investigator, would disqualify the subject from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NOSE Responder Rate | 3 months postprocedure. | The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate | 7 days, 30 days, and 6, 12, 18 and 24 months. | Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham Control Arm Subjects in the Sham Control arm will undergo the same preoperative assessments as those in the Latera Treatment arm up to and including anesthesia for the implant, however, no implant will be placed.
Crossover - Subjects will be unblinded after the 3-month assessment is complete. Eligible subjects in the Sham Control arm will be treated with the Latera Implant if they still meet all eligibility criteria. Follow up will continue to 24 months post-implant. Subjects who no longer meet the eligibility criteria will exit the study.
Latera Implant: Treatment | 64 |
| Latera Treatment Arm Subjects in the active treatment arm will receive the Latera Implant using standard techniques. Follow up continues for 24 months post-implant.
Latera Implant: Treatment | 63 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
| Overall Study | Unblinded before 3-month follow-upa- | 0 | 6 |
Baseline characteristics
| Characteristic | Sham Control Arm | Latera Treatment Arm | Total |
|---|---|---|---|
| Age, Continuous | 51.3 years STANDARD_DEVIATION 13.5 | 50.9 years STANDARD_DEVIATION 14.2 | 51.1 years STANDARD_DEVIATION 13.8 |
| Baseline Nasal Obstruction Symptom Evaluation (NOSE) Score | 77.7 units on a scale STANDARD_DEVIATION 15.1 | 77.4 units on a scale STANDARD_DEVIATION 13.1 | 77.6 units on a scale STANDARD_DEVIATION 14.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 2 Participants | 6 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 | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 51 Participants | 58 Participants | 109 Participants |
| Region of Enrollment United States | 64 participants | 63 participants | 127 participants |
| Sex: Female, Male Female | 40 Participants | 37 Participants | 77 Participants |
| Sex: Female, Male Male | 24 Participants | 26 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 64 | 0 / 63 |
| other Total, other adverse events | 0 / 64 | 5 / 63 |
| serious Total, serious adverse events | 2 / 64 | 3 / 63 |
Outcome results
Primary
NOSE Responder Rate
The primary endpoint of the study is the NOSE Responder Rate, assessed 3 months post-procedure in the per-protocol population of the Latera and Sham arms. The Nasal Obstruction Symptom Evaluation (NOSE) is a validated patient-reported outcome assessment of 5 questions relating to nasal obstruction (congestion, obstruction, trouble breathing through the nose, trouble sleeping, unable to breath through the nose during exercise/exertion. Each question is rated on a Likert scale of 0 (no problem) to 4 (severe problem). The sum of the scores is multiplied by 5 to result in a total score that ranges from 0 to 100. NOSE scores can also be categorized as mild (5-25), moderate (30-50), severe (55-75), and extreme (80-100). A NOSE responder is defined as a participant with at least 1 NOSE class improvement or at least 20% total NOSE score reduction.
Time frame: 3 months postprocedure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sham Control Arm | NOSE Responder Rate | 35 Participants |
| Latera Treatment Arm | NOSE Responder Rate | 52 Participants |
Comparison: Null hypothesis is that the responder rate for the Latera implant treatment was not superior to the sham treatment. A maximum sample size of 124 evaluable subjects is required for 90% power and preserving a 2.5% (one-sided) type I error rate.p-value: 0.0001t-test, 1 sided
Secondary
Responder Rate
Responder Rate at 7 days, 30 days, and 6, 12, 18 and 24 months will be assessed
Time frame: 7 days, 30 days, and 6, 12, 18 and 24 months.