Efficacy and Safety of LYR-210 for the Treatment of Chronic Rhinosinusitis in Adults (ENLIGHTEN 1)

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    180
  • sponsor
    Lyra Therapeutics
Send
Updated on 9 April 2023
See if I qualify

Summary

Multicenter, phase III, randomized, blinded, controlled, parallel group with safety extension phase with crossover or continued treatment.

Description

This is a 52-week, multicenter, phase III, randomized, blinded, controlled, parallel group with a 24-week treatment period followed by a safety extension phase with crossover or continued treatment to evaluate the efficacy and safety of LYR-210 compared with sham control for treatment in adults with CRS.

Details
Condition Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
Treatment background therapy, Sham Procedure Control, LYR-210
Clinical Study IdentifierNCT05219968
SponsorLyra Therapeutics
Last Modified on9 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age ≥18
Diagnosed as having CRS
Undergone at least 2 trials of medical treatments in the past
Mean 3 cardinal symptom (3CS) score
Bilateral ethmoid disease confirmed on CT
Has been informed of the nature of the study and provided written informed consent
Agrees to comply with all study requirements
If on a waiting list for sinonasal surgery, willing to be removed from list or have surgery date cancelled for the duration of the study

Exclusion Criteria

Inability to tolerate topical anesthesia or endoscopic procedure
Previous nasal surgery
Presence of nasal polyp grade 2 or higher
Seasonal allergic rhinitis
Perennial rhinitis with symptoms that are well controlled by regular use of intranasal corticosteroids
Severe asthma
History or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, atrophic rhinitis, or odontogenic sinusitis
Obstruction preventing proper placement and retention of LYR-210 as seen on endoscopy
Anatomic variation that, in the opinion of the investigator, would adversely impact placement of LYR-210 as seen on CT
Known history of hypersensitivity or intolerance to corticosteroids
Known history of hypothalamic pituitary adrenal axial dysfunction
Previous pituitary or adrenal surgery
Dental procedure/implant on maxillary dentition within 4 weeks of the Screening visit
Past or present acute or chronic intracranial or orbital complications of CRS
History or diagnosis (in either eye) of glaucoma or ocular hypertension
Past or present functional vision in only 1 eye
Past, present, or planned organ transplant or chemotherapy with immunosuppression
Currently positive for COVID-19 or residual sinonasal symptoms from a previous COVID-19 infection
Pregnant or breast feeding. Females of child-bearing potential must test negative for pregnancy at the time of screening
Evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments
Currently participating in an investigational drug or device study
Determined by the investigator as not suitable to be enrolled
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note