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Steroid Treatments for Chronic Sinusitis with Nasal Polyps

Phase 2 & 3

Waitlist Available

Led By Marina Boruk, MD

Research Sponsored by Marina Boruk

Eligibility Criteria Checklist

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

Must have

Diagnosis of nasal polyposis and desiring surgery

Be older than 18 years old

Must not have

An oral steroid-dependent condition

Pre-existing narrow angle glaucoma or cataracts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 10 Other Conditions

Summary

This trial will compare the effectiveness of two treatments for post-operative sinus surgery recovery. One is an FDA approved steroid eluting implant, the other is carboxymethylcellulose foam (CMC) combined with triamcinolone acetonide (a steroid). Anticipated sample size is 30. This is an intrapatient control design. Subjects will be randomly assigned to receive CMC foam with triamcinolone in one nare and the steroid-eluting implant in the other. Participants will fill out preoperative and follow-up visit surveys at 7, 14, 30 and 90 days. Subjects at each

Who is the study for?

This trial is for individuals planning to undergo surgery for nasal polyps and chronic sinusitis, who can consent and commit to the study duration. It excludes those with steroid intolerance, incomplete pre-op regimens, oral steroid dependence, immune deficiencies, or pregnancy/breastfeeding; also excluded are those with narrow angle glaucoma or cataracts.

What is being tested?

The study tests if CMC foam with triamcinolone (a steroid) is as effective and more comfortable than an FDA-approved Propel Stent after sinus surgery. Each patient will have one treatment in each nostril and be monitored through surveys and nasal cavity pictures over a 90-day period.

What are the potential side effects?

Potential side effects may include discomfort from the treatments themselves, possible reactions to steroids like increased pressure in the eye (glaucoma), cataract formation, or reduced ability of the body's immune system to fight infections.

Eligibility Criteria

Inclusion Criteria

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

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I have nasal polyps and want surgery.

Exclusion Criteria

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

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I rely on oral steroids for a health condition.

Select...

I have narrow angle glaucoma or cataracts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Postoperative Perioperative Sinus Endoscopy Score

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Triamcinolone-impregnated CMC foamExperimental Treatment1 Intervention

Applied to one nostril at end of case through randomization. Experimental drug is triamcinolone-acetonide 40mg/mL. 2mL will be combined with 5mL sterile water and mixed with carboxymethylcellulose foam and placed in the nares at the conclusion of the surgery. This will only be applied once and will remain in the nares until it dissolves or 7 days.

Group II: Steroid-eluting implant (Propel)Active Control1 Intervention

Mometasone furoate implant. 370ug of mometasone furoate with each application. One application to be used at the conclusion of surgery and left in place for 1 month or less depending on if it requires removal during office debridement.

0 / 3Eligibility criteria met