Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03979209
Recruitment Status : Recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Collaborator:
Advanced Rx
Information provided by (Responsible Party):
Rush University Medical Center

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.


Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis) Drug: Nasal Mometasone Rinse Phase 1

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Potential for Cortisol Suppression With the Use of High Volume Nasal Mometasone Irrigations in Varying Dosages.
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : August 23, 2019
Estimated Study Completion Date : August 23, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Mometasone

Arm Intervention/treatment
Experimental: Mometasone 1mg
1mg capsule dissolved in 240mg saline solution nasal irrigation
Drug: Nasal Mometasone Rinse
Nasal irrigation twice a day (BID) of assigned dose.

Experimental: Mometasone 2mg
2mg capsule dissolved in 240mg saline solution nasal irrigation
Drug: Nasal Mometasone Rinse
Nasal irrigation twice a day (BID) of assigned dose.

Experimental: Mometasone 4mg
4mg capsule dissolved in 240mg saline solution nasal irrigation
Drug: Nasal Mometasone Rinse
Nasal irrigation twice a day (BID) of assigned dose.




Primary Outcome Measures :
  1. AM Serum Cortisol Level [ Time Frame: 12 weeks ]
    The potential for cortisol suppression will be assessed with AM cortisol level after continuous nasal mometasone irrigation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03979209


Contacts
Layout table for location contacts
Contact: Bobby Tajudeen, MD 312-942-6100 bobby_tajudeen@rush.edu
Contact: Stephanie Chinapen, BS 312-942-9967 stephanie_chinapen@rush.edu

Locations
Layout table for location information
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Bobby Tajudeen, MD    312-942-6100    bobby_tajudeen@rush.edu   
Contact: Stephanie Chinapen, BS    312-942-9967    stephanie_chinapen@rush.edu   
Principal Investigator: Bobby Tajudeen, MD         
Sponsors and Collaborators
Rush University Medical Center
Advanced Rx
Investigators
Layout table for investigator information
Principal Investigator: Bobby Tajudeen, MD Rush University Medical Center

Publications:
Pulmicort(R) [package insert]. Wilmington, DE: AstraZeneca; 2000.
Brattsand, R. What factors determine anti-inflammatory activity and selectivity of inhaled steroids? Eur. Respir. Rev. 1997, 7, 356- 361.
Nasonex(R) [package insert]. Whitehouse Station, NJ: Merk & CO.,INC; 1997.
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.

Layout table for additonal information
Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03979209    
Other Study ID Numbers: 17121505
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Rush University Medical Center:
Cortisol Suppression
Mometasone
Chronic Rhinosinusitis
Steroid Irrigations
Additional relevant MeSH terms:
Layout table for MeSH terms
Sinusitis
Chronic Disease
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Mometasone Furoate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents