Potential for Cortisol Suppression With the Use of High Volume Nasal Mometasone Irrigations in Varying Dosages.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rush University Medical Center

Must not be taking: Systemic corticosteroids, Oral estrogens

Disqualifiers: Adrenal insufficiency, Liver disease, Morbid obesity, Pregnancy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests different doses of mometasone in nasal irrigation for patients with chronic sinusitis. The goal is to see if it affects cortisol levels in the body. Mometasone helps reduce nasal inflammation and is less likely to enter the bloodstream, making it safer for long-term use. Mometasone furoate has been used in various forms, such as nasal sprays and gels, to treat sinusitis and reduce nasal inflammation.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used systemic corticosteroids in the past month or are taking medications that affect the HPA axis (a system that controls stress response and other body processes).

What data supports the effectiveness of the drug Nasal Mometasone Rinse?

Research shows that mometasone furoate nasal spray, a component of the nasal rinse, significantly improves symptoms and quality of life in patients with rhinosinusitis and allergic rhinitis. This suggests that the nasal rinse could be effective for similar conditions. ^{1 2 3 4 5}

Is Nasal Mometasone Rinse safe for humans?

Mometasone furoate nasal spray, which is similar to Nasal Mometasone Rinse, is generally safe for humans. It does not reach high levels in the bloodstream and is not linked to serious side effects, with common mild effects being nosebleeds, headaches, and sore throat. ^{2 4 6 7 8}

How is nasal mometasone rinse different from other treatments for sinus conditions?

Nasal mometasone rinse is unique because it involves flushing a solution containing mometasone, a corticosteroid, through the sinonasal cavity, providing direct contact with the nasal tissues. This method may offer more targeted relief compared to standard nasal sprays, which are typically used for conditions like allergic rhinitis. ^{1 2 4 9 10}

Research Team

Bobby Tajudeen, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

Inclusion Criteria

Age 18+

Diagnosis of Chronic Rhinosinusitis, with or without nasal polyposis

History of prior endosopic sinus surgery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive nasal mometasone irrigations in varying dosages for 12 weeks

12 weeks

Daily self-administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) for blood draw

Treatment Details

Interventions

• Nasal Mometasone Rinse

Participant Groups

Group I: Mometasone 4mg Experimental Treatment 1 Intervention

4mg capsule dissolved in 240mg saline solution nasal irrigation

Group II: Mometasone 2mg Experimental Treatment 1 Intervention

2mg capsule dissolved in 240mg saline solution nasal irrigation

Group III: Mometasone 1mg Experimental Treatment 1 Intervention

1mg capsule dissolved in 240mg saline solution nasal irrigation

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Advanced Rx

Industry Sponsor

Trials

1

Recruited

20+

Findings from Research

Mometasone furoate nasal spray is a potent treatment for allergic rhinitis and nasal polyposis that has negligible systemic exposure, minimizing the risk of significant side effects compared to oral corticosteroids.

Clinical trials involving around 4,500 patients show that mometasone furoate does not suppress the hypothalamus-pituitary-adrenal axis or inhibit growth in children, confirming its safety and tolerability profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mometasone furoate nasal spray: a review of safety and systemic effects. Zitt, M., Kosoglou, T., Hubbell, J.[2022]

References

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

Effective dose range of mometasone furoate nasal spray in the treatment of acute rhinosinusitis. [2015]

2. Turkey pubmed.ncbi.nlm.nih.gov

The effect of topical mometasone furoate nasal spray on carriage of Staphylococcus aureus. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of mometasone furoate nasal spray on quality of life of patients with acute rhinosinusitis. [2015]

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

Mometasone absorption in cultured airway epithelium. [2020]

5. Denmark pubmed.ncbi.nlm.nih.gov

Efficacy of mometasone furoate nasal spray in the treatment of allergic rhinitis. Meta-analysis of randomized, double-blind, placebo-controlled, clinical trials. [2015]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Mometasone furoate nasal spray: a review of safety and systemic effects. [2022]

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

The Comparison of Nasaleze and Mometasone Nasal Spray to Control the Symptoms of Allergic Rhinitis. [2023]

8. China pubmed.ncbi.nlm.nih.gov

[Clinical study on mometasone furoate nasal spray in the treatment of non-allergic rhinitis]. [2015]

9. Turkey pubmed.ncbi.nlm.nih.gov

Effects of topical sprays on allergy-induced nasal obstruction in children. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Features of mometasone furoate nasal spray and its utility in the management of allergic rhinitis. [2019]