Chronic Sinusitis Clinical Trial
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)
Verified date | May 2023 |
Source | Lyra Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 71 |
Est. completion date | February 4, 2021 |
Est. primary completion date | March 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Brisbane and Woman's Hospital | Brisbane | |
Australia | Monash Health | Clayton | |
Australia | The ENT Centre | Hornsby | |
Australia | Westmead Hospital | Westmead | |
Austria | University Hospital for Otorhinolaryngology, Medical University of Graz | Wien | |
Czechia | Fakultni Nemocnice Brno OR | Brno | |
Czechia | St Anne's Faculty Hospital | Brno | |
Czechia | Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku | Hradec Králové | Prague |
Czechia | Fakultní nemocnice Plzen | Plzen | Czech Republic |
New Zealand | Southern Clinical Trials Waitemata | Auckland | |
New Zealand | Southern Clinical Trials Ltd | Christchurch | |
New Zealand | Clinical Trials New Zealand | Hamilton | |
New Zealand | Middlemore Clinical Trials | Papatoetoe | |
New Zealand | P3 Research Tauranga | Tauranga | |
New Zealand | P3 Research Wellington | Wellington | |
New Zealand | Wellington Hospital | Wellington | |
Poland | Provita Sp. z o.o. Centrum Medyczne Angelius Provita | Katowice | |
Poland | Centrum Medyczne All-Med | Kraków | |
Poland | Centrum Medyczne Plejady | Kraków | |
Poland | Centrum Medyczne PROMED | Kraków | |
Poland | Centrum Zdrowia MDM | Warszawa | |
Poland | Vistamed Sp. z o.o. | Wroclaw |
Lead Sponsor | Collaborator |
---|---|
Lyra Therapeutics |
Australia, Austria, Czechia, New Zealand, Poland,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Week 4 | |
Secondary | 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. | 24 weeks | |
Secondary | 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. | Week 24 | |
Secondary | 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. | Week 24 | |
Secondary | The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks | To evaluate the safety and tolerability of LYR-210 | 24 weeks | |
Secondary | Plasma Drug Concentrations of MF at Week 4 | To evaluate the pharmacokinetics of LYR-210 | 4 Weeks | |
Secondary | Plasma Drug Concentrations of MF at Week 12 | To evaluate the pharmacokinetics of LYR-210 | 12 weeks |
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