Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis

The Washington University

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinosinusitis; Chronic Eosinophilic Rhinosinusitis; Chronic Rhinosinusitis (Diagnosis)

Treatments: Drug: Mometasone Nasal Spray; Drug: Mometasone Furoate Nasal Irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT03705793

201801067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups

Mometasone Furoate Nasal Irrigation

Experimental group

Description:

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.

Treatment:

Drug: Mometasone Furoate Nasal Irrigation

Mometasone Nasal Spray

Active Comparator group

Description:

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.

Treatment:

Drug: Mometasone Nasal Spray