CompletedNCT03400787Updated Feb 9, 2021Results posted

Latera RCT - Latera vs. Sham Control for Lateral Nasal Valve Collapse

An interventional study of Latera Implant and Sham Procedure in Nasal Valve Collapse and Nasal Breathing, sponsored by Spirox, Inc.. Completed at 11 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by Spirox, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 137
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

Nasal Valve Collapse
Nasal Breathing

Browse trials for

Shock 916

Keywords

nasal airway obstruction
sham-control
Polylactide absorbable implant

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility criteria

Subjects must meet the following criteria to be included in the study:

Adults aged 18 and above;
Understands and provides written informed consent;
Stated willingness to comply with all study procedures, post-treatment care and availability for the duration of the study follow up of 2 years;
In good general health as evidenced by medical history;
NOSE score ≥55;
Dynamic bi-lateral nasal wall insufficiency as confirmed by Positive Modified Cottle Maneuver;
Nasal and facial anatomy appropriate to receive the Latera Implant;
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:

Unable to tolerate or not a candidate for procedures performed under local anesthesia;
Pathology other than lateral wall insufficiency (e.g. septal deviation, turbinate or adenoid hypertrophy, polyps, sinusitis, rhinitis) is the primary contributor to airway obstruction;
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;
FESS, sinuplasty, septoplasty, inferior turbinate reduction, or rhinoplasty within the past 6 months;
Any other rhinoplasty procedures are planned or planned usage of external dilators within 24 months after the index procedure;
Permanent nasal implant of any type (e.g. autologous, homologous, or synthetic graft) or dilator;
Presence of concomitant inflammatory or infectious conditions or unhealed wounds in the treatment area (e.g., vestibulitis, vasculitis, active acne),
Currently using chronic systemic steroids or recreational intra-nasal drugs;
Currently has cancerous or pre-cancerous nasal lesions, has had radiation in the treatment area, or is currently receiving chemotherapy;
History of a significant healing disorders including hypertrophic scarring, or keloid formation;
Poorly controlled diabetes mellitus;
Known or suspected allergy to PLA or other absorbable implant materials in the Latera Implant;
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;
Female subjects, of child bearing potential, known or suspected to be pregnant or are lactating;
Any other presenting condition that, in the medical opinion of the investigator, would disqualify the subject from the study.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 137 participants (actual)

Study arms

Sham comparator
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.
Device: Latera Implant
Experimental
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.
Device: Sham Procedure

Interventions

DeviceLatera Implant
Treatment with implant
DeviceSham Procedure
Sham procedure where the Latera delivery device is inserted but no implant delivered.

What researchers measure

Primary outcomes

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.

Secondary outcomes

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.

Results

Posted Jan 9, 2020

Participant flow

Participant flow — Overall Study
Milestone	Sham Control Arm	Latera Treatment Arm
Started	66	71
3-month follow-up	64	63
Completed	64	63
Not completed	2	8
Withdrew: Lost to follow-up	1	0
Withdrew: Death	1	0
Withdrew: Protocol violation	0	2
Withdrew: Unblinded before 3-month follow-upa-	0	6

Outcome measures

PrimaryNOSE 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.
Reported as:: Count of participants · Participants

NOSE Responder Rate
Participants	Sham Control Arm	Latera Treatment Arm
NOSE Responder Rate	35	52

Statistical analysis

Sham Control Arm vs Latera Treatment Arm · t-test, 1 sided · p = 0.0001 (p\<0.025 indicates statistical significance.)

SecondaryResponder 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.

Results for this outcome have not been posted.

Adverse events

Collected over Adverse events reported from procedure through 3-month follow-up.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Sham Control Arm	1/64 (1.6%)	2/64 (3.1%)	0/64 (0%)
Latera Treatment Arm	0/63 (0%)	3/63 (4.8%)	5/63 (7.9%)

Most frequent serious events

Most frequent serious events
Event	Sham Control Arm	Latera Treatment Arm
Liver cancerHepatobiliary disorders	0/64	1/63
Degenerative disc disease/stenosisMusculoskeletal and connective tissue disorders	0/64	1/63
Severe hypertensionGeneral disorders	0/64	1/63
DeathGeneral disorders	1/64	0/63
Orthopedic surgeryMusculoskeletal and connective tissue disorders	1/64	0/63

Most frequent other events

Most frequent other events
Event	Sham Control Arm	Latera Treatment Arm
Implant extrusion/migrationProduct Issues	0/64	5/63

Baseline characteristics

Participants with evaluable data for the primary endpoint at 3-month follow-up

Age, Continuous
Age, Continuous(years)	Sham Control Arm	Latera Treatment Arm	Total
Mean	51.3 ± 13.5	50.9 ± 14.2	51.1 ± 13.8

Sex: Female, Male
Sex: Female, Male(Participants)	Sham Control Arm	Latera Treatment Arm	Total
Female	40	37	77
Male	24	26	50

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Sham Control Arm	Latera Treatment Arm	Total
American Indian or Alaska Native	1	1	2
Asian	5	2	7
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	1	0	1
White	51	58	109
More than one race	4	2	6
Unknown or Not Reported	2	0	2

Region of Enrollment
Region of Enrollment(participants)	Sham Control Arm	Latera Treatment Arm	Total
United States	64	63	127

Baseline Nasal Obstruction Symptom Evaluation (NOSE) Score
Baseline Nasal Obstruction Symptom Evaluation (NOSE) Score(units on a scale)	Sham Control Arm	Latera Treatment Arm	Total
Mean	77.7 ± 15.1	77.4 ± 13.1	77.6 ± 14.1

Study locations

11 sites

Sacramento ENT
Roseville, California 95661, United States
Breathe Clear Institute
Torrance, California 90503, United States
ENT of GA
Atlanta, Georgia 30342, United States
Chicago Nasal and Sinus Center
Chicago, Illinois 60602, United States
Michiana Sleep and ENT Solutions
South Bend, Indiana 46635, United States
Albany ENT & Allergy
Albany, New York 12206, United States
Piedmont ENT
Winston-Salem, North Carolina 27103, United States
Texas ENT Specialist
Houston, Texas 77094, United States
ENT Associates of Texas
McKinney, Texas 78209, United States
Texas Facial Plastics and ENT
San Antonio, Texas 78239, United States
Ogden Clinic
Ogden, Utah 84403, United States

References and documents

Publications

Stolovitzky P, Senior B, Ow RA, Mehendale N, Bikhazi N, Sidle DM. Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol. 2019 Aug;9(8):850-856. doi: 10.1002/alr.22362. Epub 2019 Jun 21. PubMed 31226238 ↗

Study documents

Study protocol · Mar 23, 2018
Statistical analysis plan · Feb 12, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03400787
Lead sponsor: Spirox, Inc.
Collaborators: New Arch Consulting
Responsible party: Sponsor
First posted: Jan 17, 2018
Start date: Nov 28, 2017
Primary completion: Feb 1, 2019
Completion: Dec 23, 2020
Results posted: Jan 9, 2020
Last update: Feb 9, 2021

Study contacts

Pablo Stolovitzky, MD

principal investigator · ENT of Georgia

Douglas Sidle, MD

principal investigator · Northwestern Facial Plastic Surgery

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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