Trial · NCT04041609
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
NCT04041609, Phase 2, Completed, Lyra Therapeutics; results first posted 2023-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study). Trials, record NCT04041609. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04041609
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
- NCT number
- NCT04041609
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 71 participants, actual
- Lead sponsor
- Lyra Therapeutics
- Conditions
- Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
- Interventions
- LYR-210, Sham comparator
- First posted
- 2019-08-01
- Last updated
- 2023-07-25
- Other registries' IDs
- eudract:2018-004621-89
- Results first posted
- 2023-06-06
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 | Week 4 | 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. |
| Secondary | Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24 | 24 weeks | 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. |
| Secondary | CFBL in Chronic Sinusitis Symptom Scores at Week 24 | Week 24 | 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. |
| Secondary | Participants With Improved Bilateral Zinreich Score at Week 24 | Week 24 | 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. |
| Secondary | The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks | 24 weeks | To evaluate the safety and tolerability of LYR-210 |
| Secondary | Plasma Drug Concentrations of MF at Week 4 | 4 Weeks | To evaluate the pharmacokinetics of LYR-210 |
| Secondary | Plasma Drug Concentrations of MF at Week 12 | 12 weeks | To evaluate the pharmacokinetics of LYR-210 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 | Week 4 | 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 | score on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24 | 24 weeks | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | CFBL in Chronic Sinusitis Symptom Scores at Week 24 | Week 24 | score on a scale | LEAST_SQUARES_MEAN | |
| SECONDARY | Participants With Improved Bilateral Zinreich Score at Week 24 | Week 24 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks | 24 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Drug Concentrations of MF at Week 4 | 4 Weeks | Participants who had evaluable plasma concentration at week 4. | pg/mL | MEAN |
| SECONDARY | Plasma Drug Concentrations of MF at Week 12 | 12 weeks | Participants who had evaluable plasma concentration at week 12. | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group19
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 | LYR-210 (Low Dose) | -2.24 | Standard Error 0.637 | score on a scale | |
| Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 | LYR-210 (High Dose) | -2.65 | Standard Error 0.651 | score on a scale | |
| Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 | Sham Procedure | -2.28 | Standard Error 0.611 | score on a scale | |
| Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24 | LYR-210 (Low Dose) | -30.0 | Standard Error 5.32 | score on a scale | |
| Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24 | LYR-210 (High Dose) | -40.7 | Standard Error 5.76 | score on a scale | |
| Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24 | Sham Procedure | -21.7 | Standard Error 5.10 | score on a scale | |
| CFBL in Chronic Sinusitis Symptom Scores at Week 24 | LYR-210 (Low Dose) | -3.36 | Standard Error 0.668 | score on a scale | |
| CFBL in Chronic Sinusitis Symptom Scores at Week 24 | LYR-210 (High Dose) | -4.32 | Standard Error 0.682 | score on a scale | |
| CFBL in Chronic Sinusitis Symptom Scores at Week 24 | Sham Procedure | -2.68 | Standard Error 0.640 | score on a scale | |
| Participants With Improved Bilateral Zinreich Score at Week 24 | LYR-210 (Low Dose) | 13 | Participants |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LYR-210 (Low Dose) | 24 | |
| Overall Study | STARTED | LYR-210 (High Dose) | 23 | |
| Overall Study | STARTED | Sham Procedure | 24 | |
| Overall Study | COMPLETED | LYR-210 (Low Dose) | 17 | |
| Overall Study | COMPLETED | LYR-210 (High Dose) | 15 | |
| Overall Study | COMPLETED | Sham Procedure | 17 | |
| Overall Study | NOT COMPLETED | LYR-210 (Low Dose) | 7 | |
| Overall Study | NOT COMPLETED | LYR-210 (High Dose) | 8 | |
| Overall Study | NOT COMPLETED | Sham Procedure | 7 |
Source ClinicalTrials.gov
Adverse events39
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Facial Pain | General disorders | LYR-210 (Low Dose) | 1 | 24 | |
| other | Facial Pain | General disorders | LYR-210 (High Dose) | 2 | 23 | |
| other | Facial Pain | General disorders | Sham Procedure | 0 | 23 | |
| other | Chronic Sinusitis | Infections and infestations | LYR-210 (Low Dose) | 4 | 24 | |
| other | Chronic Sinusitis | Infections and infestations | LYR-210 (High Dose) | 4 | 23 | |
| other | Chronic Sinusitis | Infections and infestations | Sham Procedure | 7 | 23 | |
| other | Rhinitis | Infections and infestations | LYR-210 (Low Dose) | 1 | 24 | |
| other | Rhinitis | Infections and infestations | LYR-210 (High Dose) | 4 | 23 | |
| other | Rhinitis | Infections and infestations | Sham Procedure | 0 | 23 | |
| other | Upper respiratory tract infection | Infections and infestations | LYR-210 (Low Dose) | 2 | 24 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LYR-210 (Low Dose) | 0 | 24 |
| Total, all-cause mortality | LYR-210 (High Dose) | 0 | 23 |
| Total, all-cause mortality | Sham Procedure | 0 | 23 |
| Total, other adverse events | LYR-210 (Low Dose) | 15 | 24 |
| Total, other adverse events | LYR-210 (High Dose) | 13 | 23 |
| Total, other adverse events | Sham Procedure | 12 | 23 |
| Total, serious adverse events | LYR-210 (Low Dose) | 1 | 24 |
| Total, serious adverse events | LYR-210 (High Dose) | 0 | 23 |
| Total, serious adverse events | Sham Procedure | 1 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34534410 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04041609
GET https://conductscience.org/api/trials/v1/NCT04041609/events?page=2