NCT04041609

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2019

Geographic Reach
4 countries

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2019

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2021

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

June 6, 2023

Completed
Last Updated

July 25, 2023

Status Verified

May 1, 2023

Enrollment Period

11 months

First QC Date

July 12, 2019

Results QC Date

May 10, 2023

Last Update Submit

July 11, 2023

Conditions

Chronic SinusitisChronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24

    24 weeks

  • CFBL in Chronic Sinusitis Symptom Scores at Week 24

    Week 24

  • Participants With Improved Bilateral Zinreich Score at Week 24

    Week 24

  • The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks

    24 weeks

  • Plasma Drug Concentrations of MF at Week 4

    4 Weeks

  • +1 more secondary outcomes

Study Arms (3)

LYR-210 (Low Dose)

EXPERIMENTAL

In-office bilateral placement of the LYR-210 drug depot (mometasone furoate low dose) in the middle meatus

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

Drug: LYR-210

Sham Procedure

SHAM COMPARATOR

In-office bilateral sham procedure

Other: Sham comparator

Interventions

LYR-210DRUG

A single administration of LYR-210 depot

LYR-210 (High Dose)LYR-210 (Low Dose)
Sham comparatorOTHER

Sham comparator

Sham Procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (22)

Royal Brisbane and Woman's Hospital

Brisbane, Australia

Location

Monash Health

Clayton, 3168, Australia

Location

The ENT Centre

Hornsby, 2077, Australia

Location

Westmead Hospital

Westmead, 2145, Australia

Location

University Hospital for Otorhinolaryngology, Medical University of Graz

Vienna, Austria

Location

Fakultní nemocnice Plzeň

Pilsen, Czech Republic, 305 99, Czechia

Location

Fakultni Nemocnice Hradec Kralove Klinika otorinolaryngologie a chirurgie hlavy a krku

Hradec Králové, Prague, 500 05, Czechia

Location

Fakultni Nemocnice Brno OR

Brno, Czechia

Location

St Anne's Faculty Hospital

Brno, Czechia

Location

Southern Clinical Trials Waitemata

Auckland, 0626, New Zealand

Location

Southern Clinical Trials Ltd

Christchurch, 8013, New Zealand

Location

Clinical Trials New Zealand

Hamilton, 3206, New Zealand

Location

Middlemore Clinical Trials

Papatoetoe, 2025, New Zealand

Location

P3 Research Tauranga

Tauranga, BOP 3110, New Zealand

Location

P3 Research Wellington

Wellington, 6021, New Zealand

Location

Wellington Hospital

Wellington, 6021, New Zealand

Location

Provita Sp. z o.o. Centrum Medyczne Angelius Provita

Katowice, Poland

Location

Centrum Medyczne All-Med

Krakow, Poland

Location

Centrum Medyczne Plejady

Krakow, Poland

Location

Centrum Medyczne PROMED

Krakow, Poland

Location

Centrum Zdrowia MDM

Warsaw, Poland

Location

Vistamed Sp. z o.o.

Wroclaw, Poland

Location

Related Publications (1)

  • 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.

    PMID: 34534410BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Lyra Clinical
Organization
Lyra Therapeutics
lyraclinical@lyratx.com
617-393-4600

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2019

First Posted

August 1, 2019

Study Start

May 9, 2019

Primary Completion

March 25, 2020

Study Completion

February 4, 2021

Last Updated

July 25, 2023

Results First Posted

June 6, 2023

Record last verified: 2023-05

Locations

AU(1)NZ(7)CZ(4)PL(6)