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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to aid recovery from sinus surgery for those with chronic sinusitis and nasal polyps. Researchers aim to determine if a foam containing the steroid triamcinolone (triamcinolone-impregnated CMC foam) is as effective or better than the usual steroid implant in reducing swelling, scarring, and other post-surgery symptoms. Participants will receive the foam in one nostril and the implant in the other for comparison. Individuals with nasal polyps planning surgery may be suitable for this study. As a Phase 2, Phase 3 trial, this research evaluates the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, allowing participants to contribute to potentially groundbreaking treatment advancements.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a special foam containing triamcinolone has been tested for safety in treating long-term sinus issues with nasal polyps. Studies indicate it can help reduce problems like scarring and swelling after surgery. Importantly, the foam has not shown serious side effects, indicating it is generally safe for patients.

Previous studies have demonstrated that the steroid-releasing implant effectively delivers medicine directly to the needed area while reducing systemic side effects. Like the foam, it is also well-tolerated by patients.

Both treatments aim to aid healing and comfort after surgery, and research supports their safety when used in nasal procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the triamcinolone-impregnated CMC foam because it offers a unique approach to treating chronic sinusitis with nasal polyps. Unlike typical treatments, which often involve oral or injectable steroids, this foam delivers triamcinolone directly to the nasal cavity, providing localized treatment. This method allows for targeted anti-inflammatory action right where it's needed, potentially reducing systemic side effects. Additionally, the foam dissolves over time, offering a controlled release of the medication and simplifying the post-surgery care process. This novel delivery system could lead to faster and more effective relief for patients.

What evidence suggests that this trial's treatments could be effective for chronic sinusitis with nasal polyps?

Research has shown that a special foam containing triamcinolone, which participants in this trial may receive, can help treat chronic sinusitis with nasal polyps. Studies suggest that this foam reduces swelling and inflammation after sinus surgery. Specifically, it improved symptoms and camera-based examinations within the first week and month after treatment. The foam delivers the medicine directly to the affected area, reducing polyp growth and inflammation. Overall, this triamcinolone foam appears to be a promising option for reducing sinus problems after surgery. ^{1 2 6 7 8}

Who Is on the Research Team?

Marina Boruk, MD

Principal Investigator

SUNY Downstate Med Ctr

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34559269/

Efficacy of triamcinolone acetonide-impregnated Gelfoam ... Conclusion: TAA-soaked Gelfoam dressing following bilateral ESS was found to be an effective method for treating CRSwNP particularly for the eosinophilic ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03607175

Adjunctive Treatment for Chronic Rhinosinusitis With Nasal ... Our primary objective is to demonstrate that triamcinolone-impregnated carboxymethylcellulose foam is noninferior to steroid-eluting implants in improving ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24819563/

Topical triamcinolone acetonide/carboxymethylcellulose ... The objective of the current study was to critically evaluate the topical application of triamcinolone acetonide (80) in carboxymethylcellulose (TA/CMC) foam ...

4. trial.medpath.com trial.medpath.com/clinical-trial/9e62a0da0e06a4ac/nct03607175-randomized-clinical-trial-nasal-polyposis

Adjunctive Treatment for Chronic Rhinosinusitis With Nasal ... This is a research study to find out if an off-label use of carboxymethylcellulose foam (CMC), an absorbable nasal packing, combined with triamcinolone ...

5. researchgate.net researchgate.net/publication/49670235_Treatment_of_Recurrent_Sinonasal_Polyposis_with_Steroid-Infused_Carboxymethylcellulose_Foam

Treatment of Recurrent Sinonasal Polyposis with Steroid- ... However, triamcinoloneinfused CMC foam improved symptoms and endoscopic outcomes at 1 week and 1 month. 58 Microporous polysaccharide ...

6. withpower.com withpower.com/trial/phase-2-and-3-nasal-polyps-6-2018-a4a1c

Steroid Treatments for 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 ...

7. researchgate.net researchgate.net/publication/257752622_Systemic_Effects_and_Safety_of_Triamcinolone-Impregnated_Nasal_Packing_after_Endoscopic_Sinus_Surgery_A_Randomized_Double-Blinded_Placebo-Controlled_Study

Systemic Effects and Safety of Triamcinolone-Impregnated ... The purpose of this study was to evaluate the systemic effects and safety of steroid-impregnated absorbable nasal packing after ESS. Patients ...

8. journals.sagepub.com journals.sagepub.com/doi/10.1177/0145561320982193

In-Office Corticosteroid Placement in the Management of ... The objective of this publication is to review the evolution of the in-office intranasal placement of corticosteroids in the management of CRS.