Trial Outcomes & Findings for Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis (NCT NCT03705793)
NCT ID: NCT03705793
Last Updated: 2025-06-26
Results Overview
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")
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
53 participants
Primary outcome timeframe
Change from Baseline to Week 8
Results posted on
2025-06-26
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
26
|
|
Overall Study
COMPLETED
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
4
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Effectiveness of Mometasone Nasal Irrigation for Chronic Rhinosinusitis
Baseline characteristics by cohort
| Measure |
Mometasone Furoate Nasal Irrigation
n=26 Participants
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.
|
Mometasone Nasal Spray
n=27 Participants
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.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
n=5 Participants
|
50 years
n=7 Participants
|
48 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Overall Comorbidity
None
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Overall Comorbidity
Mild
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Overall Comorbidity
Moderate
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Overall Comorbidity
Severe
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Endoscopy Grading Scale
|
4 units on a scale
n=5 Participants
|
4 units on a scale
n=7 Participants
|
4 units on a scale
n=5 Participants
|
|
SINO-NASAL OUTCOME TEST (SNOT-22)
|
50 units on a scale
n=5 Participants
|
40 units on a scale
n=7 Participants
|
42 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to Week 8The 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")
Outcome measures
| Measure |
Mometasone Furoate Nasal Irrigation
n=24 Participants
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.
|
Mometasone Nasal Spray
n=23 Participants
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.
|
|---|---|---|
|
Change in Sino-Nasal Outcome Test Scores (SNOT-22)
|
23.18 score on a scale
Interval 15.7 to 30.7
|
17.7 score on a scale
Interval 10.3 to 25.04
|
SECONDARY outcome
Timeframe: Week 8CGI 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.
Outcome measures
| Measure |
Mometasone Furoate Nasal Irrigation
n=24 Participants
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.
|
Mometasone Nasal Spray
n=23 Participants
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.
|
|---|---|---|
|
Number of Participants Who Score <3 on the Clinical Global Impression Scale
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to Week 8A 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.
Outcome measures
| Measure |
Mometasone Furoate Nasal Irrigation
n=24 Participants
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.
|
Mometasone Nasal Spray
n=23 Participants
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.
|
|---|---|---|
|
Change in Nasal Endoscopic Findings Using the Lund-Kennedy Grading System
|
2.2 units on a scale
Interval 1.1 to 3.3
|
2.1 units on a scale
Interval 1.0 to 3.1
|
Adverse Events
Mometasone Furoate Nasal Irrigation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mometasone Nasal Spray
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mometasone Furoate Nasal Irrigation
n=26 participants at risk
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.
|
Mometasone Nasal Spray
n=27 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
myocardial infarction
|
0.00%
0/26 • Up to 8 weeks. Adverse events were monitored/assessed through study completion.
Number of participants at risk is based on the number of participants who were randomized and allocated to the 2 arms. The number stated in the participant flow is the number of participants who completed the trial.
|
3.7%
1/27 • Number of events 1 • Up to 8 weeks. Adverse events were monitored/assessed through study completion.
Number of participants at risk is based on the number of participants who were randomized and allocated to the 2 arms. The number stated in the participant flow is the number of participants who completed the trial.
|
Other adverse events
Adverse event data not reported
Additional Information
Pawina JIramongkolchai, MD
Washington University in St. Louis
Phone: 314-362-5296
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place