What side effects are associated with this type of intervention?

Common treatments for chronic sinusitis include antibiotics, antifungal agents, and immunotherapy. Antibiotics can lead to side effects such as gastrointestinal upset, allergic reactions, and the development of antibiotic-resistant bacteria. Antifungal treatments, though less commonly used, may cause local irritation and have uncertain efficacy. Immunotherapy, including sublingual and injection forms, can result in local reactions like itching and swelling, and in rare cases, systemic reactions such as anaphylaxis. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

FDA-approved treatments for chronic sinusitis include various pharmacological and non-pharmacological options. Pharmacological treatments often involve the use of intranasal corticosteroids, such as fluticasone propionate, to reduce inflammation. Antibiotics may be prescribed for bacterial infections, while mucolytics like N-acetylcysteine (NAC) are used to liquefy mucus. Additionally, sublingual immunotherapy (SLIT) tablets have been approved for allergic rhinitis, which can be associated with chronic sinusitis. Non-pharmacological treatments include saline nasal irrigation and, in some cases, surgical interventions to improve sinus drainage.

What other types of research exist?

One promising novel alternative for Chronic Sinusitis treatment is LYR-210, which is currently being evaluated in a phase III clinical trial. LYR-210 is a bioabsorbable nasal implant designed to deliver a continuous, steady dose of mometasone furoate directly to the sinonasal tissues over an extended period. This treatment aims to reduce inflammation and improve symptoms in patients with chronic rhinosinusitis. Patients should discuss with their healthcare provider to determine if this treatment is suitable for their condition.

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Other

LYR-210 for Chronic Sinusitis (ENLIGHTEN 1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Lyra Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergone at least 2 trials of medical treatments in the past

Age ≥18

Must not have

Past, present, or planned organ transplant or chemotherapy with immunosuppression

Presence of nasal polyp grade 2 or higher

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 24

Awards & highlights

Pivotal Trial

Summary

This trial is testing LYR-210 to see if it helps adults with chronic sinus problems by reducing swelling and opening nasal passages. LYR-210 is a new method designed to provide continuous treatment for patients with long-term sinus issues who have not improved with other treatments.

Who is the study for?

Adults over 18 with chronic sinusitis, confirmed by CT scan, who've tried at least two medical treatments without success. They must understand the study and consent to participate. Excluded are those with previous nasal surgery, severe allergies well-controlled by steroids, current participation in other studies, pregnancy or breastfeeding women, and various conditions that could interfere with LYR-210 placement or affect survival.

What is being tested?

The trial is testing LYR-210 against a sham procedure (placebo) for treating chronic sinusitis. Participants will also continue their usual sinus treatments. It's a large-scale phase III study where participants are randomly assigned to treatment groups and don't know which group they're in.

What are the potential side effects?

Possible side effects of LYR-210 may include reactions related to corticosteroid sensitivity such as increased risk of infection, potential hormonal imbalances affecting the adrenal glands, glaucoma or ocular hypertension risks due to steroid exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried at least 2 different medical treatments before.

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I am 18 years old or older.

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I have been diagnosed with CRS.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had, am having, or will have an organ transplant or chemotherapy that weakens my immune system.

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I have nasal polyps that are moderate to severe.

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I have been diagnosed with glaucoma or high eye pressure.

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I have had surgery on my nose before.

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I have had surgery on my pituitary or adrenal gland.

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I can only see out of one eye.

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I have or might have a serious fungal infection in my sinuses.

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I cannot tolerate skin numbing creams or internal camera examinations.

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I am not pregnant or breastfeeding, and if capable of becoming pregnant, I have tested negative for pregnancy.

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I have had brain or eye complications from a sinus condition.

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I currently have COVID-19 or lingering symptoms from a past infection.

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I have severe asthma.

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I have a known issue with my adrenal gland function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from baseline (CFBL) in the 7-day average composite score of 3 cardinal symptoms (3CS) in participants without nasal polyps.

Secondary study objectives

CFBL in the 22-item Sino-Nasal Outcome Test (SNOT-22) total score at Week 24

CFBL in the 3-D volumetric CT score at Week 20

CFBL in the 7-day average composite score of 3CS in all participants at Week 24.

+1 more

Side effects data

From 2021 Phase 2 trial • 71 Patients • NCT04041609

17%

Chronic Sinusitis

17%

Rhinitis

13%

Epistaxis

Rhinorrhoea

Facial Pain

Upper respiratory tract infection

Oropharyngeal pain

Headache

100%

80%

60%

40%

20%

Study treatment Arm

LYR-210 (High Dose)

LYR-210 (Low Dose)

Sham Procedure

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LYR-210Experimental Treatment2 Interventions

Single administration of LYR-210 drug matrix (7500 μg)

Group II: Sham procedure controlPlacebo Group2 Interventions

Single mock administration procedure

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LYR-210

2022

Completed Phase 3

~270

0 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Chronic Sinusitis include antibiotics, corticosteroids, and saline irrigation. Antibiotics target and eliminate bacterial infections that can exacerbate sinusitis. Corticosteroids reduce inflammation in the sinus tissues, helping to alleviate swelling and improve sinus drainage. Saline irrigation helps to clear mucus and debris from the nasal passages, promoting better airflow and reducing congestion. These mechanisms are crucial for Chronic Sinusitis patients as they address the underlying causes of symptoms, improve breathing, and prevent further complications.

Developing a core outcome set for chronic rhinosinusitis: a systematic review of outcomes utilised in the current literature.Topical therapies in the management of chronic rhinosinusitis: an evidence-based review with recommendations.