Clinical trial NCT04041609: LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Lead sponsor: Lyra Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-08-01
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4
timeFrame: Week 4
Secondary outcomes:
measure: Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24
timeFrame: 24 weeks
measure: CFBL in Chronic Sinusitis Symptom Scores at Week 24
timeFrame: Week 24
measure: Participants With Improved Bilateral Zinreich Score at Week 24
timeFrame: Week 24
measure: The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks
timeFrame: 24 weeks
measure: Plasma Drug Concentrations of MF at Week 4
timeFrame: 4 Weeks
measure: Plasma Drug Concentrations of MF at Week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane and Woman's Hospital
city: Clayton
country: Australia
facility: Monash Health
city: Hornsby
country: Australia
facility: The ENT Centre
city: Westmead
country: Australia
facility: Westmead Hospital
city: Wien
country: Austria
facility: University Hospital for Otorhinolaryngology, Medical University of Graz
city: Plzen
country: Czechia
facility: Fakultní nemocnice Plzeň
state: Czech Republic
city: Hradec Králové
country: Czechia
facility: Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku
state: Prague
city: Brno
country: Czechia
facility: Fakultni Nemocnice Brno OR
city: Brno
country: Czechia
facility: St Anne's Faculty Hospital
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Waitemata
city: Christchurch
country: New Zealand
facility: Southern Clinical Trials Ltd
city: Hamilton
country: New Zealand
facility: Clinical Trials New Zealand
city: Papatoetoe
country: New Zealand
facility: Middlemore Clinical Trials
city: Tauranga
country: New Zealand
facility: P3 Research Tauranga
city: Wellington
country: New Zealand
facility: P3 Research Wellington
city: Wellington
country: New Zealand
facility: Wellington Hospital
city: Katowice
country: Poland
facility: Provita Sp. z o.o. Centrum Medyczne Angelius Provita
city: Kraków
country: Poland
facility: Centrum Medyczne All-Med
city: Kraków
country: Poland
facility: Centrum Medyczne Plejady
city: Kraków
country: Poland
facility: Centrum Medyczne PROMED
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Wrocław
country: Poland
facility: Vistamed Sp. z o.o.
Study officials:
References:
citation: 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.