Allergic Rhinosinusitis, Chronic Eosinophilic Rhinosinusitis, Chronic Rhinosinusitis (Diagnosis)
Conditions
Keywords
mometasone irrigation chronic rhinosinusitis, mometasone spray, rhinosinusitis
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.
Interventions
DRUGMometasone Furoate Nasal Irrigation
Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.
Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Sino-Nasal Outcome Test Scores (SNOT-22) | Change from Baseline to Week 8 | The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how bad their rhinosinusitis is 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. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome. All relevant time points used in the calculation in the Time Frame (e.g., 'baseline and 8 weeks) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Score <3 on the Clinical Global Impression Scale | 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. |
| Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System | Change from Baseline to 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. The The Lund Kennedy System grades the pathologic state of the nasal cavity based on the presence of polyps, nasal discharge, and mucosal edema. Polyps graded from 0 to 2 (0=absent, 1=limited to middle meatus, 2=extending to nasal cavity) Discharge graded from 0 to 2 (0=absent, 1=thin/clear, 2=thick) Edema graded from 0 to 2 (0=absent, 1=mild/moderate, 2=polypoid degeneration). Scores are added for each side of the nose with a minimum score of 0 and maximum score of 12 with higher scores indicating more severe sinonasal inflammation. |
Countries
United States
Participant flow
Pre-assignment details
Mometasone Furoate Nasal Irrigation Arm 3 participants lost to follow-up 2 participants withdrew Mometasone Nasal Spray Arm 4 participants lost to follow-up 1 participant withdrew While 53 participants were initially enrolled, a total of 7 participants were lost to follow-up and 3 participants withdrew. Thus, the total number of participants who completed the study was 43.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Mometasone Furoate Nasal Irrigation: Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray. | 26 |
| 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.
Mometasone Nasal Spray: Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray. | 27 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Irrigation | Mometasone Nasal Spray | Total |
|---|---|---|---|
| Age, Continuous | 48 years | 50 years | 48 years |
| Endoscopy Grading Scale | 4 units on a scale | 4 units on a scale | 4 units on a scale |
| Overall Comorbidity Mild | 6 Participants | 12 Participants | 18 Participants |
| Overall Comorbidity Moderate | 2 Participants | 3 Participants | 5 Participants |
| Overall Comorbidity None | 14 Participants | 12 Participants | 26 Participants |
| Overall Comorbidity Severe | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 4 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 17 Participants | 21 Participants | 38 Participants |
| Sex: Female, Male Female | 15 Participants | 18 Participants | 33 Participants |
| Sex: Female, Male Male | 11 Participants | 9 Participants | 20 Participants |
| SINO-NASAL OUTCOME TEST (SNOT-22) | 50 units on a scale | 40 units on a scale | 42 units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 27 |
| other Total, other adverse events | 0 / 26 | 0 / 27 |
| serious Total, serious adverse events | 0 / 26 | 1 / 27 |
Outcome results
Primary
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
The change in Sino-Nasal Outcome Test scores (SNOT-22) scores pre- and post-treatment between the two arms was measured. The Sino-Nasal Outcome Test asks subjects to rate how bad their rhinosinusitis is 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. The SNOT includes 22 questions (symptoms and social/emotional consequences of rhinosinusitis), each of which are rated from 0 to 5 for a minimum score of 0 to maximum score of 110, with higher scores representing worse outcome. All relevant time points used in the calculation in the Time Frame (e.g., 'baseline and 8 weeks)
Time frame: Change from Baseline to Week 8
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Mometasone Furoate Nasal Irrigation | Change in Sino-Nasal Outcome Test Scores (SNOT-22) | 23.18 score on a scale |
| Mometasone Nasal Spray | Change in Sino-Nasal Outcome Test Scores (SNOT-22) | 17.7 score on a scale |
Secondary
Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System
A board-certified otolaryngologist will perform a nasal endoscopic examination pre- and post-intervention and findings recorded using the Lund-Kennedy grading system. The The Lund Kennedy System grades the pathologic state of the nasal cavity based on the presence of polyps, nasal discharge, and mucosal edema. Polyps graded from 0 to 2 (0=absent, 1=limited to middle meatus, 2=extending to nasal cavity) Discharge graded from 0 to 2 (0=absent, 1=thin/clear, 2=thick) Edema graded from 0 to 2 (0=absent, 1=mild/moderate, 2=polypoid degeneration). Scores are added for each side of the nose with a minimum score of 0 and maximum score of 12 with higher scores indicating more severe sinonasal inflammation.
Time frame: Change from Baseline to Week 8
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Mometasone Furoate Nasal Irrigation | Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System | 2.2 units on a scale |
| Mometasone Nasal Spray | Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System | 2.1 units on a scale |
Secondary
Number of Participants Who Score <3 on the Clinical Global Impression Scale
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.
Time frame: Week 8
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mometasone Furoate Nasal Irrigation | Number of Participants Who Score <3 on the Clinical Global Impression Scale | 22 Participants |
| Mometasone Nasal Spray | Number of Participants Who Score <3 on the Clinical Global Impression Scale | 20 Participants |