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Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT03705793
Recruitment Status : Not yet recruiting
First Posted : October 15, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
Chronic rhinosinusitis (CRS) affects up to 12.5% of the US population and has a significant disease burden. The recommended medical management of CRS includes large-volume, low-pressure saline lavage, systemic antibiotics, and intranasal corticosteroids (INCS). While the efficacy and safety of INCS are well-established for the long-term management of CRS, penetration of INCS beyond the nasal vestibule and into the paranasal sinuses is limited. The aim of this study is to evaluate the effectiveness of mometasone furoate large-volume, low-pressure nasal irrigation for surgery-naive CRS patients.

Condition or disease Intervention/treatment Phase
Chronic Rhinosinusitis (Diagnosis) Allergic Rhinosinusitis Chronic Eosinophilic Rhinosinusitis Drug: Mometasone Furoate Nasal Irrigation Drug: Mometasone Nasal Spray Phase 4

Detailed Description:
Mometasone furoate nasal spray (MFNS) is a INCS that is used in the management of CRS. The overall goal of this proposed research project is to optimize topical delivery of MF to the paranasal sinuses in surgery-naive CRS patients through the use of high-volume, low-pressure nasal saline irrigation. The investigators will be conducting a single-site, double-blinded, placebo-controlled randomized clinical trial (RCT) in which we propose to evaluate the effectiveness of MF nasal irrigation compared to MF nasal spray.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mometasone Furoate Nasal Irrigation
The study intervention will be mometasone furoate powder (1.2 mg/capsule) and placebo nasal spray. The placebo nasal spray will contain the same inert ingredients found in MF nasal spray: glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The placebo nasal spray will be packaged identically to the mometasone nasal spray. Participants will be required to dissolve the contents of two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.
Drug: Mometasone Furoate Nasal Irrigation
Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.

Active Comparator: Mometasone Nasal Spray
The study intervention will be mometasone nasal spray (50 mcg/spray) and placebo nasal irrigation. The placebo will contain lactose monohydrate and will be supplied in capsules identical to the budesonide capsules. Participants will be required to dissolve the contents of the two capsules into an 8-ounce (240 mL) sinus rinse bottle along with the saline rinse. All participants will be instructed to perform the following once daily: irrigation of both right and left nasal cavity with one-half of the contents of the nasal rinse followed by 2 sprays per nostril of the nasal spray.
Drug: Mometasone Nasal Spray
Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.
Other Name: Nasonex




Primary Outcome Measures :
  1. Change in Sino-Nasal Outcome Test scores (SNOT-22) [ Time Frame: Baseline, Week 2, Week 4, Week 6, Week 8 ]
    Within- and between participant changes in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment. The Sino-Nasal Outcome Test asks subjects to rate how "bad" their rhinosinusitis by using a 0-5 point scale with 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be.


Secondary Outcome Measures :
  1. Change in Clinical Global Impression Scale (CGI) [ Time Frame: Week 8 ]
    CGI asks subjects to rate their overall response to treatment using a 7-point Likert scale with anchors of 1=very much improved, 4=no change, and 7=very much worse.

  2. Nasal Endoscopic Findings [ Time Frame: Baseline, Week 8 ]
    A board-certified otolaryngologist will perform a nasal endoscopic examination pre- and post-intervention and findings recorded using the Lund-Kennedy grading system.

  3. Radiologic Findings [ Time Frame: Baseline, Week 8 ]
    Radiologic examinations, including CT scans of the paranasal sinuses, are not required for study enrollment. However, if participants receive paranasal sinus CT scans as part of their clinical work-up, the radiologic images will be reviewed and findings recorded using the Lund-McKay grading system. The radiologic data may possibly be included in the data analysis.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

12-weeks or longer of two or more of the following signs and symptom consistent with CRS:

  • mucopurulent drainage(anterior, posterior, or both)
  • nasal obstruction (congestion)
  • facial pain-pressure-fullness
  • and decreased sense of smell

AND inflammation documented by one or more of the following findings:

  • purulent mucus or edema in the middle meatus or ethmoid region
  • radiographic imaging showing inflammation of the paranasal sinuses.

Exclusion Criteria:

  • inability to speak or understand English
  • nasal polyps
  • history of nasal or sinus surgery
  • comorbid mucociliary conditions
  • dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease
  • history of oral or systematic antibiotic use in the past 2 weeks
  • history of allergy to MF or other topical steroids
  • pregnant or breastfeeding
  • participants with a baseline SNOT-22 score of 9 or less will be excluded due to inability to achieve a minimally clinically improved difference pre- and post-intervention.

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): NCT03705793


Contacts
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Contact: Pawina Jiramongkolchai, MD 314-362-5296 pawina@wustl.edu

Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine

Publications:

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03705793     History of Changes
Other Study ID Numbers: 201801067
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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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.: Yes

Keywords provided by Washington University School of Medicine:
mometasone irrigation, mometasone spray, chronic rhinosinusitis

Additional relevant MeSH terms:
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Sinusitis
Chronic Disease
Rhinitis, Allergic
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes
Pathologic Processes
Rhinitis
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents