Chronic SinusitisPhase 2NCT04041609
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
A Phase 2 study testing LYR-210 in people with Chronic Sinusitis and Chronic Rhinosinusitis (Diagnosis), run by Lyra Therapeutics at 22 sites in 5 countries.
Trial summary
This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- LYR-210
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 22 sitesin 5 countries
- Study dates
- 9 May 2019to 4 Feb 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of CS.
- Two trials of medical treatments for CS in the past.
- Minimum CS symptom score.
- Ability to tolerate topical anesthesia.
- Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
- Agrees to comply with all study requirements.
Who cannot join
- Have undergone previous sinus surgery.
- Pregnant or breast feeding.
- Known history of hypersensitivity or intolerance to corticosteroids.
- History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
- Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
- Had dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit.
Show all 10Show fewer
- Past or present functional vision in only one eye.
- Has cataracts
- Past, present, or planned organ transplant or chemotherapy with immunosuppression.
- Currently participating in an investigational drug or device study
Trial locations and contacts
22 sites in 5 countries.
22 sites in 5 countries
New Zealand7 sites
Southern Clinical Trials Waitemata
Auckland, 0626
Southern Clinical Trials Ltd
Christchurch, 8013
Clinical Trials New Zealand
Hamilton, 3206
Middlemore Clinical Trials
Papatoetoe, 2025
P3 Research Tauranga
Tauranga, BOP 3110
P3 Research Wellington
Wellington, 6021
Wellington Hospital
Wellington, 6021
Poland6 sites
Provita Sp. z o.o. Centrum Medyczne Angelius Provita
Katowice
Centrum Medyczne All-Med
Krakow
Centrum Medyczne Plejady
Krakow
Centrum Medyczne PROMED
Krakow
Centrum Zdrowia MDM
Warsaw
Vistamed Sp. z o.o.
Wroclaw
Australia4 sites
Royal Brisbane and Woman's Hospital
Brisbane
Monash Health
Clayton, 3168
The ENT Centre
Hornsby, 2077
Westmead Hospital
Westmead, 2145
Czechia4 sites
Fakultni Nemocnice Brno OR
Brno
St Anne's Faculty Hospital
Brno
Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku
Hradec Králové, Prague, 500 05
Fakultní nemocnice Plzeň
Pilsen, Czech Republic, 305 99
Austria1 site
University Hospital for Otorhinolaryngology, Medical University of Graz
Vienna
About this study
Official title: A Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects With Chronic Sinusitis (LANTERN Study)
This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.
Read the detailed description
LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. Once in place, each LYR-210 drug depot is designed to gradually deliver sustained topical doses of MF to the inflamed mucosal sinus tissue over 24 weeks.
- Being tested
- LYR-210, Sham comparator
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYR-210Drug
A single administration of LYR-210 depot
Sham comparatorOther
Sham comparator
| Study group | Role | What they receive |
|---|---|---|
| LYR-210 (Low Dose) | Experimental | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus Receives: Drug: LYR-210 |
| LYR-210 (High Dose) | Experimental | In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus Receives: Drug: LYR-210 |
| Sham Procedure | Sham comparator | In-office bilateral sham procedure Receives: Other: Sham comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at 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.
Measured: Week 4
Secondary outcomes (6)
Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24
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.
Measured: 24 weeks
CFBL in Chronic Sinusitis Symptom Scores at 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.
Measured: Week 24
Participants With Improved Bilateral Zinreich Score at 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.
Measured: Week 24
The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks
To evaluate the safety and tolerability of LYR-210
Measured: 24 weeks
Plasma Drug Concentrations of MF at Week 4
To evaluate the pharmacokinetics of LYR-210
Measured: 4 Weeks
Plasma Drug Concentrations of MF at Week 12
To evaluate the pharmacokinetics of LYR-210
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start9 May 2019
- Primary completion25 Mar 2020
- Study completion4 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyra Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041609
- Sponsor's protocol ID
- LYR-210-2018-002
- Other IDs
- 2018-004621-89, 2018
- Status last verified
- May 2023
- First submitted
- 12 Jul 2019
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All Individual Participant Data (IPD) that underlie results in a publication may be available to other researchers.
Publications
Cervin A, Rimmer J, Wrobel A, Abelak Y, Brayton L, Kuang Y. Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study. Int Forum Allergy Rhinol. 2022 Feb;12(2):147-159. doi: 10.1002/alr.22883. Epub 2021 Sep 17.
PubMed 34534410
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects With Chronic Sinusitis (LANTERN Study)
- ClinicalTrials.gov ID
- NCT04041609
- Acronym / sponsor ID
- LYR-210-2018-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Lyra TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 May 2019 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 4 Feb 2021 (actual)
- First posted
- 1 Aug 2019 (actual)
- Results
- Posted 6 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, Randomized, Blinded, Sham Procedure-Controlled, Parallel-Group Trial to Evaluate the Efficacy, Safety and Tolerability of LYR-210 in Adult Subjects with Chronic Sinusitis.
Detailed description
LYR-210 is a drug depot, which contains the anti-inflammatory medication mometasone furoate (MF) pre-loaded in a single use applicator. LYR-210 is intended to be placed bilaterally into the sino-nasal passages by an otolaryngologist. Once in place, each LYR-210 drug depot is designed to gradually deliver sustained topical doses of MF to the inflamed mucosal sinus tissue over 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LYR-210 (Low Dose) | Experimental | Drug: LYR-210In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus |
| LYR-210 (High Dose) | Experimental | Drug: LYR-210In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus |
| Sham Procedure | Sham comparator | Other: Sham comparatorIn-office bilateral sham procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of CS.
- Two trials of medical treatments for CS in the past.
- Minimum CS symptom score.
- Ability to tolerate topical anesthesia.
- Has been informed of the nature of the study and has provided written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site.
Key exclusion criteria (10 listed)
- Have undergone previous sinus surgery.
- Pregnant or breast feeding.
- Known history of hypersensitivity or intolerance to corticosteroids.
- History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis.
- Known history of hypothalamic pituitary adrenal axial dysfunction or having a morning serum cortisol level at screening outside of the normal range.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LYR-210A single administration of LYR-210 depot | Drug | LYR-210 (High Dose), LYR-210 (Low Dose) |
| Sham comparatorSham comparator | Other | Sham Procedure |
Primary outcome
Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4
Time frame: 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.
6 secondary outcomes
Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24
Time frame: 24 weeks
CFBL in Chronic Sinusitis Symptom Scores at Week 24
Time frame: Week 24
Participants With Improved Bilateral Zinreich Score at Week 24
Time frame: Week 24
The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks
Time frame: 24 weeks
Plasma Drug Concentrations of MF at Week 4
Time frame: 4 Weeks
Plasma Drug Concentrations of MF at Week 12
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34534410Cervin A, Rimmer J, Wrobel A, Abelak Y, Brayton L, Kuang Y. Long-acting implantable corticosteroid matrix for chronic rhinosinusitis: Results of LANTERN Phase 2 randomized controlled study. Int Forum Allergy Rhinol. 2022 Feb;12(2):147-159. doi: 10.1002/alr.22883. Epub 2021 Sep 17.
- Individual participant dataSharing planned: Undecided. All Individual Participant Data (IPD) that underlie results in a publication may be available to other researchers.
Related trials for Chronic Sinusitis
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
22 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LYR-210 in people with Chronic Sinusitis and Chronic Rhinosinusitis (Diagnosis), run by Lyra Therapeutics at 22 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in New Zealand, Poland, Australia, Czechia, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04041609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.