Steroid Treatments for Chronic Sinusitis with Nasal Polyps

Overseen By Matthew D Adams, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Marina Boruk

Must not be taking: Oral steroids

Disqualifiers: Intolerance to corticosteroids, Immune deficiency, Glaucoma, Cataracts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 1 month

30 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a research study to find out if an off-label use of carboxymethylcellulose foam (CMC), an absorbable nasal packing, combined with triamcinolone acetonide, a steroid, is more comfortable postoperatively for participants and is as effective in decreasing scarring, swelling and crusting after surgery than an FDA approved steroid eluting implant. Anticipated sample size will be 30. Study 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 visit will also have pictures taken of the nasal cavities to be scored for later analysis. Paired t-tests will be performed for analysis. Our primary objective is to demonstrate that triamcinolone-impregnated carboxymethylcellulose foam is noninferior to steroid-eluting implants in improving postoperative ethmoid inflammation, middle turbinate position, preventing intranasal synechiae and reducing polypoid change with objective measurement scales Our secondary objects include assessing the quality-of-life and nasal obstruction symptoms before and after functional endoscopic sinus surgery with validated SNOT-22 and NOSE questionnaires and to assess the cost-effectiveness of triamcinolone-impregnated carboxymethylcellulose foam versus steroid-eluting implant in management of CRSwNP in the early postoperative period. The endpoints are the POSE scores, the SNOT-22 and NOSE scores at days 7, 14, 30 and 90.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have an oral steroid-dependent condition, you cannot participate in the trial.

What data supports the effectiveness of the drug Triamcinolone-impregnated CMC foam for treating chronic sinusitis with nasal polyps?

Research shows that triamcinolone, when used in various forms like Gelfoam nasal packs or bioabsorbable packing, helps manage chronic sinusitis with nasal polyps, especially after sinus surgery. These studies suggest that triamcinolone can reduce inflammation and prevent the regrowth of nasal polyps, indicating its potential effectiveness in the CMC foam form as well. ^{1 2 3 4 5}

Is triamcinolone-impregnated CMC foam safe for treating chronic sinusitis with nasal polyps?

Triamcinolone-impregnated CMC foam has been studied for safety in treating chronic sinusitis with nasal polyps, showing a reduction in postoperative complications like crusting and swelling without significant side effects reported in the studies. ^{1 2 4 6 7}

How is the steroid treatment for chronic sinusitis with nasal polyps different from other treatments?

This treatment uses a foam infused with triamcinolone acetonide, a type of steroid, which is applied directly to the nasal area. This method targets the affected area more precisely and reduces the risk of side effects associated with oral steroids, making it a safer alternative for managing chronic sinusitis with nasal polyps after surgery. ^{1 2 3 8 9}

Research Team

Marina Boruk, MD

Principal Investigator

SUNY Downstate Med Ctr

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to follow all study rules and attend all appointments.

Provision of signed and dated informed consent form

I have nasal polyps and want surgery.

Exclusion Criteria

You have had bad reactions to corticosteroids in the past.

Subjects that did not complete the pre-op medical regimen described below

I rely on oral steroids for a health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a steroid-eluting implant or triamcinolone-impregnated CMC foam post-surgery

1 month

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with surveys and nasal cavity scoring

90 days

4 visits (in-person) at days 7, 14, 30, and 90

Treatment Details

Interventions

• Triamcinolone-impregnated CMC foam

Trial Overview 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.

Participant Groups

Group I: Triamcinolone-impregnated CMC foam Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

Marina Boruk

Lead Sponsor

Trials

1

Recruited

30+

State University of New York - Downstate Medical Center

Collaborator

Trials

67

Recruited

12,100+

References

1. United States pubmed.ncbi.nlm.nih.gov

Topical triamcinolone acetonide/carboxymethylcellulose foam for acute exacerbations of chronic rhinosinusitis/nasal polyposis. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of triamcinolone acetonide-impregnated Gelfoam nasal pack in management of chronic sinusitis with nasal polyps following endoscopic sinus surgery: a perfectly matched, placebo-controlled trial study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Triamcinolone-impregnated bioabsorbable middle meatus packing following endoscopic sinus surgery: A prospective randomized controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Prevention of relapses of nasal polyposis with intranasal triamcinolone acetonide after polyp surgery: a prospective double-blind, placebo-controlled, randomised study with a 9-month follow-up. [2014]

5. United States pubmed.ncbi.nlm.nih.gov

A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Mometasone furoate gel: a novel in-office treatment of recalcitrant postoperative chronic rhinosinusitis. [2015]

7. India pubmed.ncbi.nlm.nih.gov

Triamcinolone Impregnated Nasal Pack in Endoscopic Sinus Surgery: Our Experience. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Treatment of recurrent sinonasal polyposis with steroid-infused carboxymethylcellulose foam. [2016]

9. United States pubmed.ncbi.nlm.nih.gov

Management of early nasal polyposis using a steroid-impregnated nasal dressing. [2016]