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Trial record 1 of 1 for:    LYR-210-2018-002
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LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)

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ClinicalTrials.gov Identifier: NCT04041609
Recruitment Status : Completed
First Posted : August 1, 2019
Results First Posted : June 6, 2023
Last Update Posted : July 25, 2023
Sponsor:
Information provided by (Responsible Party):
Lyra Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Interventions Drug: LYR-210
Other: Sham comparator
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Hide Arm/Group Description

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate 2500 µg) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate 7500 µg) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator
Period Title: Overall Study
Started 24 23 24
Completed 17 15 17
Not Completed 7 8 7
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure Total
Hide Arm/Group Description

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator

 Total of all reporting groups
Overall Number of Baseline Participants 23 21 23 67
Hide Baseline Analysis Population Description
The primary analysis set for efficacy is the Intent-to-treat (ITT) set which includes all randomized subjects who received the study treatment and had a post-Day 1 assessment available.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 21 participants 23 participants 67 participants
42.3  (12.72) 46.9  (12.72) 41.3  (14.68) 43.4  (13.44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 23 participants 67 participants
Female
12
  52.2%
8
  38.1%
12
  52.2%
32
  47.8%
Male
11
  47.8%
13
  61.9%
11
  47.8%
35
  52.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 23 participants 67 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
23
 100.0%
21
 100.0%
23
 100.0%
67
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 21 participants 23 participants 67 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
22
  95.7%
21
 100.0%
22
  95.7%
65
  97.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.3%
0
   0.0%
1
   4.3%
2
   3.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 23 participants 21 participants 23 participants 67 participants
New Zealand 1 1 1 3
Australia 4 2 2 8
Europe 18 18 20 56
1.Primary Outcome
Title Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4
Hide Description Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom 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 scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT analysis set: all randomized subjects who receive the study treatment or have a treatment attempt on Day 1 and have post-Day 1 assessments available
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Hide Arm/Group Description:

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator
Overall Number of Participants Analyzed 23 21 23
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-2.24  (0.637) -2.65  (0.651) -2.28  (0.611)
2.Secondary Outcome
Title Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24
Hide Description Participants score the severity of their symptoms and social/emotional consequences of CS on a 6-point scale: 0 = no problem, 1 = very mild problem, 2 = mild or slight problem, 3 = moderate problem, 4 = severe problem, 5 = problem as bad as it can be. The scores are summed in the range of 0-110; higher scores indicate higher severity of symptoms or social/emotional consequences of CS.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Hide Arm/Group Description:

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator
Overall Number of Participants Analyzed 23 21 23
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-30.0  (5.32) -40.7  (5.76) -21.7  (5.10)
3.Secondary Outcome
Title CFBL in Chronic Sinusitis Symptom Scores at Week 24
Hide Description Participants score their CS symptoms on a 4-point scale as follows: 0 = absent symptoms (no sign/symptom 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 scores are summed and averaged over the proceeding 7 days; higher scores indicate higher severity of symptoms of CS.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Hide Arm/Group Description:

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator
Overall Number of Participants Analyzed 23 21 23
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-3.36  (0.668) -4.32  (0.682) -2.68  (0.640)
4.Secondary Outcome
Title Participants With Improved Bilateral Zinreich Score at Week 24
Hide Description Each sinus is assigned a score based on the percentage of opacification as follows: 0 = 0%, 1 = 1% to 25%, 2 = 26% to 50%, 3 = 51% to 75%, 4 = 76 % to 99%, 5 = 100% or completely occluded. Each sinus pair has a bilateral score in the range of 0 to 10. Higher scores indicate higher severity of sinus opacification. Responder is defined as a participant with at least a 1-point decrease in the imaging score at Week 24 compared with baseline.
Time Frame Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
The outcome measure is based on the Intent-to-treat (ITT) set which includes all randomized subjects who received the study treatment and had a post-Day 1 imaging assessment which could be analyzed by the imaging core lab.
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Hide Arm/Group Description:

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator
Overall Number of Participants Analyzed 19 19 18
Measure Type: Count of Participants
Unit of Measure: Participants
13
  68.4%
14
  73.7%
10
  55.6%
5.Secondary Outcome
Title The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks
Hide Description To evaluate the safety and tolerability of LYR-210
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Hide Arm/Group Description:

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator
Overall Number of Participants Analyzed 24 23 23
Measure Type: Count of Participants
Unit of Measure: Participants
11
  45.8%
5
  21.7%
5
  21.7%
6.Secondary Outcome
Title Plasma Drug Concentrations of MF at Week 4
Hide Description To evaluate the pharmacokinetics of LYR-210
Time Frame 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had evaluable plasma concentration at week 4.
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Hide Arm/Group Description:

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator
Overall Number of Participants Analyzed 20 16 0
Mean (Standard Deviation)
Unit of Measure: pg/mL
13.6110  (5.21710) 45.3500  (11.40783)
7.Secondary Outcome
Title Plasma Drug Concentrations of MF at Week 12
Hide Description To evaluate the pharmacokinetics of LYR-210
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who had evaluable plasma concentration at week 12.
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Hide Arm/Group Description:

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator
Overall Number of Participants Analyzed 16 14 0
Mean (Standard Deviation)
Unit of Measure: pg/mL
21.6500  (7.77869) 30.9143  (12.04657)
Time Frame 1 year
Adverse Event Reporting Description AEs are collected from the time of informed consent until week 48/EOS visit. The safety analysis population contains all subjects who were randomized and either received the study treatment (Sham or either dose of LYR-210) or had a treatment attempt on Day 1.
 
Arm/Group Title LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Hide Arm/Group Description

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

LYR-210: A single administration of LYR-210 depot

In-office bilateral sham procedure

Sham comparator: Sham comparator
All-Cause Mortality
LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)      0/23 (0.00%)      0/23 (0.00%)    
Hide Serious Adverse Events
LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/24 (4.17%)      0/23 (0.00%)      1/23 (4.35%)    
Infections and infestations       
Acarodermatitis *  1/24 (4.17%)  1 0/23 (0.00%)  0 0/23 (0.00%)  0
Chronic Sinusitis *  0/24 (0.00%)  0 0/23 (0.00%)  0 1/23 (4.35%)  1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LYR-210 (Low Dose) LYR-210 (High Dose) Sham Procedure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/24 (62.50%)      13/23 (56.52%)      12/23 (52.17%)    
General disorders       
Facial Pain *  1/24 (4.17%)  2/23 (8.70%)  0/23 (0.00%) 
Infections and infestations       
Chronic Sinusitis *  4/24 (16.67%)  4/23 (17.39%)  7/23 (30.43%) 
Rhinitis *  1/24 (4.17%)  4/23 (17.39%)  0/23 (0.00%) 
Upper respiratory tract infection *  2/24 (8.33%)  1/23 (4.35%)  1/23 (4.35%) 
Metabolism and nutrition disorders       
Hyperkalaemia *  0/24 (0.00%)  0/23 (0.00%)  2/23 (8.70%) 
Nervous system disorders       
Dizziness *  2/24 (8.33%)  0/23 (0.00%)  0/23 (0.00%) 
Headache *  2/24 (8.33%)  1/23 (4.35%)  3/23 (13.04%) 
Respiratory, thoracic and mediastinal disorders       
Epistaxis *  4/24 (16.67%)  3/23 (13.04%)  1/23 (4.35%) 
Nasal congestion *  2/24 (8.33%)  0/23 (0.00%)  0/23 (0.00%) 
Oropharyngeal pain *  0/24 (0.00%)  1/23 (4.35%)  2/23 (8.70%) 
Rhinorrhoea *  4/24 (16.67%)  2/23 (8.70%)  1/23 (4.35%) 
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Lyra Clinical
Organization: Lyra Therapeutics
Phone: 617-393-4600
EMail: lyraclinical@lyratx.com
Publications:
Layout table for additonal information
Responsible Party: Lyra Therapeutics
ClinicalTrials.gov Identifier: NCT04041609    
Other Study ID Numbers: LYR-210-2018-002
2018-004621-89 ( EudraCT Number )
First Submitted: July 12, 2019
First Posted: August 1, 2019
Results First Submitted: May 10, 2023
Results First Posted: June 6, 2023
Last Update Posted: July 25, 2023