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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04041609




Registration number
NCT04041609
Ethics application status
Date submitted
12/07/2019
Date registered
1/08/2019

Titles & IDs
Public title
LYR-210 Depot (LYR-210) for Adult Subjects With Chronic Sinusitis (LANTERN Study)
Scientific 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)
Secondary ID [1] 0 0
2018-004621-89
Secondary ID [2] 0 0
LYR-210-2018-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Sinusitis 0 0
Chronic Rhinosinusitis (Diagnosis) 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LYR-210
Other interventions - Sham comparator

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

Experimental: LYR-210 (High Dose) - In-office bilateral placement of the LYR-210 drug depot (mometasone furoate high dose) in the middle meatus

Sham comparator: Sham Procedure - In-office bilateral sham procedure


Treatment: Drugs: LYR-210
A single administration of LYR-210 depot

Other interventions: Sham comparator
Sham comparator
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline (CFBL) in Chronic Sinusitis Symptom Scores at Week 4
Timepoint [1] 0 0
Week 4
Secondary outcome [1] 0 0
Change From Baseline in the 22-item Sino-nasal Outcome Test (SNOT-22) Total Score at Week 24
Timepoint [1] 0 0
24 weeks
Secondary outcome [2] 0 0
CFBL in Chronic Sinusitis Symptom Scores at Week 24
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Participants With Improved Bilateral Zinreich Score at Week 24
Timepoint [3] 0 0
Week 24
Secondary outcome [4] 0 0
The Number of Participants With Treatment-related Adverse Events for up to 24 Weeks
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Plasma Drug Concentrations of MF at Week 4
Timepoint [5] 0 0
4 Weeks
Secondary outcome [6] 0 0
Plasma Drug Concentrations of MF at Week 12
Timepoint [6] 0 0
12 weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/02/2021
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Brisbane and Woman's Hospital - Brisbane
Recruitment hospital [2] 0 0
Monash Health - Clayton
Recruitment hospital [3] 0 0
The ENT Centre - Hornsby
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 0 0
- Brisbane
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2077 - Hornsby
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Wien
Country [2] 0 0
Czechia
State/province [2] 0 0
Czech Republic
Country [3] 0 0
Czechia
State/province [3] 0 0
Prague
Country [4] 0 0
Czechia
State/province [4] 0 0
Brno
Country [5] 0 0
New Zealand
State/province [5] 0 0
Auckland
Country [6] 0 0
New Zealand
State/province [6] 0 0
Christchurch
Country [7] 0 0
New Zealand
State/province [7] 0 0
Hamilton
Country [8] 0 0
New Zealand
State/province [8] 0 0
Papatoetoe
Country [9] 0 0
New Zealand
State/province [9] 0 0
Tauranga
Country [10] 0 0
New Zealand
State/province [10] 0 0
Wellington
Country [11] 0 0
Poland
State/province [11] 0 0
Katowice
Country [12] 0 0
Poland
State/province [12] 0 0
Kraków
Country [13] 0 0
Poland
State/province [13] 0 0
Warszawa
Country [14] 0 0
Poland
State/province [14] 0 0
Wroclaw

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lyra Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
All Individual Participant Data (IPD) that underlie results in a publication may be available to other researchers.


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT04041609