What side effects are associated with this type of intervention?

Common treatments for chronic sinusitis that reduce inflammation or act as antimicrobials include nasal corticosteroids, antibiotics, and nasal saline irrigations. Nasal corticosteroids, such as fluticasone and mometasone, can cause side effects like nasal irritation, nosebleeds, and, rarely, nasal septum perforation. Antibiotics, such as amoxicillin-clavulanate or doxycycline, may lead to gastrointestinal issues, allergic reactions, and the development of antibiotic-resistant bacteria. Nasal saline irrigations are generally safe but can cause minor discomfort or irritation. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

There is limited specific information on prior FDA approvals for treatments of Chronic Sinusitis in the provided context. However, treatments for chronic sinusitis often include intranasal corticosteroids, which reduce inflammation, and antibiotics for bacterial infections. Examples of intranasal corticosteroids include fluticasone propionate and mometasone furoate, which are commonly used to manage symptoms by reducing nasal inflammation. Antimicrobial treatments may include antibiotics like amoxicillin-clavulanate for bacterial sinusitis. These treatments aim to alleviate symptoms and prevent complications associated with chronic sinusitis.

What other types of research exist?

Promising alternatives to GLS-1200 Nasal Spray for chronic sinusitis include: 1) Topical antibiotics such as ofloxacin, which have shown efficacy in treating otitis media and may be beneficial for sinusitis due to their antimicrobial properties. 2) Topical antiseptics like povidone-iodine, which have been evaluated for their effectiveness in chronic suppurative otitis media and could potentially reduce microbial load in sinusitis. 3) Sublingual immunotherapy (SLIT) for allergic rhinitis, which may help in reducing inflammation and improving symptoms in patients with allergic components to their sinusitis.

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GLS-1200 Nasal Spray for Chronic Sinusitis

Phase 2

Waitlist Available

Research Sponsored by GeneOne Life Science, Inc.

Eligibility Criteria Checklist

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

Must have

Elective FESS

Age 18 years or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week post-op through week 16

Awards & highlights

Study Summary

This trial will test a new nasal spray to see if it's safe and effective for people with chronic sinusitis who have had surgery.

Who is the study for?

Adults over 18 with chronic sinusitis who've had or will have elective endoscopic sinus surgery can join. They must be able to follow the study plan and give informed consent. Women should use birth control if they can have children. People with latex allergies, certain medical histories like blood cancers, bone marrow transplants, or those on chemotherapy are excluded.Check my eligibility

What is being tested?

The trial is testing GLS-1200 nasal spray's safety and how well it works in preventing sinus infections after sinus surgery compared to a placebo (a treatment with no active drug). Participants will receive either the real spray or placebo alongside standard post-surgery care.See study design

What are the potential side effects?

Possible side effects of GLS-1200 aren't detailed here but may include typical reactions to nasal sprays such as irritation, discomfort, or an allergic reaction. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for elective sinus surgery.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week post-op through week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week post-op through week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week post-op through week 16 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment

Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment

Secondary outcome measures

Assess antibiotic usage relative to treatment assignment

Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GLS-1200Experimental Treatment1 Intervention

3 ml of GLS-1200 (1 mg/ml in 0.9% saline)

Group II: Sterile SalinePlacebo Group1 Intervention

3 ml of 0.9% saline

0 / 2Eligibility 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

Common treatments for Chronic Sinusitis include nasal corticosteroids, saline nasal irrigation, and antibiotics. Nasal corticosteroids, such as fluticasone and mometasone, reduce inflammation in the sinus cavities, helping to alleviate swelling and improve sinus drainage. Saline nasal irrigation helps to clear mucus and allergens from the nasal passages, reducing congestion and promoting sinus health. Antibiotics are used to treat bacterial infections that may be contributing to sinusitis symptoms. These treatments are important for Chronic Sinusitis patients as they address the underlying inflammation and infection, providing relief from symptoms and preventing complications.

Topical and systemic antifungal therapy for chronic rhinosinusitis.