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

NCT03979209 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 17121505
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

In the United States, more than 30 million people are diagnosed with sinusitis each year. Moreover, chronic sinusitis effects approximately 15% of the U.S. population and is one of the most common chronic illnesses in America. Budesonide and mometasone nasal sprays are used to relieve sneezing, runny, stuffy, or itchy nose caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). The objective of this study is to determine the incidence of cortisol suppression with the use of mometasone irrigations in varying doses. Low levels of cortisol can cause weakness, fatigue, and low blood pressure. In using nasal sprays, a drug may enter the body's circulation through direct local absorption in the nasal mucosa or oral absorption of any swallowed medication. Some people can reduce symptom severity using medication, including antihistamines and anti-inflammatory drugs. Nasal irrigation - the flooding of the sinus cavity with warm saline solution - can help to reduce sinus congestion and is often recommended by otolaryngologists for a variety of sinus conditions. The goal of nasal irrigation is to clear excess mucus and foreign debris out of the sinuses, and to moisturize the mucosal membrane. The practice has been subjected to clinical testing and has been found to be safe and beneficial with no apparent side effects. The addition of budesonide to nasal irrigations has become common practice in the treatment of chronic rhinosinusitis. Mometasone has been shown to be an alternative to budesonide with increased local effects and lower absorption by the body. Studies have shown that saline irrigation treatments show greater effects versus saline spray for providing short-term relief of chronic nasal and sinus symptoms. There is limited data on the use of mometasone in nasal irrigations. Subjects to be included in the study are those with a diagnosis of chronic rhinosinusitis, with or without nasal polyps and who have had prior endoscopic sinus surgery. This study will test 3 different concentrations of mometasone in a nasal irrigation. Patients will receive either 1 milligram mometasone in their nasal irrigations, 2 milligrams of mometasone, or 4 milligrams of mometasone. The dose assignment will be determined by the treating physician. After 12 weeks of entering this study and use of the mometasone irrigations, there will be a blood draw to compare morning cortisol levels to a baseline blood draw.

Conditions

Chronic Rhinosinusitis (Diagnosis)

Keywords

Cortisol Suppression; Mometasone; Chronic Rhinosinusitis; Steroid Irrigations

Outcome Measures

Primary Outcomes (1)

• Morning "AM" Serum Cortisol Level

  The potential for cortisol suppression will be assessed with "AM" cortisol level after continuous nasal mometasone irrigation.

  Morning (AM) at week 12,

Study Arms (3)

Mometasone 1mg

EXPERIMENTAL

1mg capsule dissolved in 240mg saline solution nasal irrigation

Drug: Nasal Mometasone Rinse

Mometasone 2mg

EXPERIMENTAL

2mg capsule dissolved in 240mg saline solution nasal irrigation

Drug: Nasal Mometasone Rinse

Mometasone 4mg

EXPERIMENTAL

4mg capsule dissolved in 240mg saline solution nasal irrigation

Drug: Nasal Mometasone Rinse

Interventions

Nasal Mometasone Rinse DRUG

Nasal irrigation twice a day (BID) of assigned dose.

Mometasone 1mg; Mometasone 2mg; Mometasone 4mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Diagnosis of Chronic Rhinosinusitis, with or without nasal polyposis
• History of prior endosopic sinus surgery
• Must include at least ethmoidectomy with maxillary antrostomy

You may not qualify if:

• Exposure to systemic corticosteroids within one month of the date of enrolment in to the study.
• Adrenal insufficiency
• Liver disease
• Use of oral estrogens in women
• Morbid obesity (BMI more than 38)
• Concurrent pregnancy
• Use of medications which may alter HPA axis(refer to Drugs that affect HPAA)
• Ciliary dysmotility, cystic fibrosis, sarcoidosis, systemic vasculitis, IgG or IgA deficiency, known pituitary or adrenal disease

Sponsors & Collaborators

• Rush University Medical Center: lead
• Advanced Rx: collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (13)

• Smith KA, French G, Mechor B, Rudmik L. Safety of long-term high-volume sinonasal budesonide irrigations for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Mar;6(3):228-32. doi: 10.1002/alr.21700. Epub 2016 Jan 11.

  PMID: 26750509 BACKGROUND

• Soudry E, Wang J, Vaezeafshar R, Katznelson L, Hwang PH. Safety analysis of long-term budesonide nasal irrigations in patients with chronic rhinosinusitis post endoscopic sinus surgery. Int Forum Allergy Rhinol. 2016 Jun;6(6):568-72. doi: 10.1002/alr.21724. Epub 2016 Feb 16.

  PMID: 26879335 BACKGROUND

• Derendorf H, Meltzer EO. Molecular and clinical pharmacology of intranasal corticosteroids: clinical and therapeutic implications. Allergy. 2008 Oct;63(10):1292-300. doi: 10.1111/j.1398-9995.2008.01750.x.

  PMID: 18782107 BACKGROUND

• Sastre J, Mosges R. Local and systemic safety of intranasal corticosteroids. J Investig Allergol Clin Immunol. 2012;22(1):1-12.

  PMID: 22448448 BACKGROUND

• Pulmicort(R) [package insert]. Wilmington, DE: AstraZeneca; 2000.

  BACKGROUND

• Hochhaus G. Pharmacokinetic/pharmacodynamic profile of mometasone furoate nasal spray: potential effects on clinical safety and efficacy. Clin Ther. 2008 Jan;30(1):1-13. doi: 10.1016/j.clinthera.2008.01.005.

  PMID: 18343239 BACKGROUND

• Lipworth BJ, Jackson CM. Safety of inhaled and intranasal corticosteroids: lessons for the new millennium. Drug Saf. 2000 Jul;23(1):11-33. doi: 10.2165/00002018-200023010-00002.

  PMID: 10915030 BACKGROUND

• Corren J. Intranasal corticosteroids for allergic rhinitis: how do different agents compare? J Allergy Clin Immunol. 1999 Oct;104(4 Pt 1):S144-9. doi: 10.1016/s0091-6749(99)70310-6.

  PMID: 10518811 BACKGROUND

• Brattsand, R. What factors determine anti-inflammatory activity and selectivity of inhaled steroids? Eur. Respir. Rev. 1997, 7, 356- 361.

  BACKGROUND

• Harvey RJ, Debnath N, Srubiski A, Bleier B, Schlosser RJ. Fluid residuals and drug exposure in nasal irrigation. Otolaryngol Head Neck Surg. 2009 Dec;141(6):757-61. doi: 10.1016/j.otohns.2009.09.006.

  PMID: 19932850 BACKGROUND

• Nasonex(R) [package insert]. Whitehouse Station, NJ: Merk & CO.,INC; 1997.

  BACKGROUND

• Davies RJ, Nelson HS. Once-daily mometasone furoate nasal spray: efficacy and safety of a new intranasal glucocorticoid for allergic rhinitis. Clin Ther. 1997 Jan-Feb;19(1):27-38; discussion 2-3. doi: 10.1016/s0149-2918(97)80070-7.

  PMID: 9083706 BACKGROUND

• Brannan, M. D., Seiberling, M., Cutler, D. L., Cuss, F. M., & Affrime, M. B. (1996, January). Lack of systemic activity with intranasal mometasone furoate. In JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY (Vol. 97, No. 1, pp. 62-62). 11830 WESTLINE INDUSTRIAL DR, ST LOUIS, MO 63146-3318: MOSBY-YEAR BOOK INC.

  BACKGROUND

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Bobby Tajudeen, MD
• Organization: Rush UMC

Bobby_Tajudeen@rush.edu

312-942-6100

Study Officials

• Bobby Tajudeen, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The sample size is 45 patients. Patients will sign the consent form and get a baseline morning cortisol blood draw to confirm eligibility. Once enrolled, they will be instructed on how to perform the nasal irrigation twice a day with a 240 milliliter saline filled Neilmed bottle. Patients will receive either the 1 milligram mometasone dose, 2 milligram mometasone dose, or 4 milligram of mometasone dose. The dose assignment will be determined by the treating physician. After 12 weeks of continuous use of the mometasone irrigation, there will be a repeat morning blood draw to compare cortisol levels to the baseline blood draw.

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 7, 2019
• Study Start: January 14, 2019
• Primary Completion: June 22, 2021
• Study Completion: July 28, 2022
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)