Trials / Completed
CompletedNCT04041609
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Lyra Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LYR-210 | A single administration of LYR-210 depot |
| OTHER | Sham comparator | Sham comparator |
Timeline
- Start date
- 2019-05-09
- Primary completion
- 2020-03-25
- Completion
- 2021-02-04
- First posted
- 2019-08-01
- Last updated
- 2023-07-25
- Results posted
- 2023-06-06
Locations
22 sites across 5 countries: Australia, Austria, Czechia, New Zealand, Poland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04041609. Inclusion in this directory is not an endorsement.