Clinical trial NCT03705793: Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
Official title: Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Rhinosinusitis (Diagnosis)
Allergic Rhinosinusitis
Chronic Eosinophilic Rhinosinusitis
Keywords: mometasone irrigation, mometasone spray, chronic rhinosinusitis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Sino-Nasal Outcome Test Scores (SNOT-22)
timeFrame: Change from Baseline to Week 8
Secondary outcomes:
measure: Number of Participants Who Score <3 on the Clinical Global Impression Scale
timeFrame: Week 8
measure: Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System
timeFrame: Change from Baseline to Week 8
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jay F Piccirillo, MD
role: PRINCIPAL_INVESTIGATOR
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