Trial Outcomes & Findings for Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332) (NCT NCT01135134)
NCT ID: NCT01135134
Last Updated: 2024-05-28
Results Overview
Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
333 participants
Primary outcome timeframe
Baseline and 2 weeks (or discontinuation)
Results posted on
2024-05-28
Participant Flow
Participant milestones
| Measure |
MFNS
Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.
|
Placebo
Placebo MFNS. Administration was as follows:
* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
220
|
113
|
|
Overall Study
COMPLETED
|
218
|
112
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
MFNS
Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.
|
Placebo
Placebo MFNS. Administration was as follows:
* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Did not meet protocol eligibility
|
1
|
0
|
Baseline Characteristics
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
Baseline characteristics by cohort
| Measure |
MFNS
n=220 Participants
Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.
|
Placebo
n=113 Participants
Placebo MFNS. Administration was as follows:
* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 5 and 11 years
|
146 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
220 Participants
n=5 Participants
|
|
Age, Customized
Between 12 and 15 years
|
74 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
130 Participants
n=5 Participants
|
75 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2 weeks (or discontinuation)Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Outcome measures
| Measure |
MFNS
n=220 Participants
Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.
|
Placebo
n=113 Participants
Placebo MFNS. Administration was as follows:
* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.
|
|---|---|---|
|
Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
|
-3.9850 score on a scale
Standard Error 0.1633
|
-1.9081 score on a scale
Standard Error 0.2233
|
SECONDARY outcome
Timeframe: Baseline and 1 weekTotal nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Outcome measures
| Measure |
MFNS
n=219 Participants
Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.
|
Placebo
n=113 Participants
Placebo MFNS. Administration was as follows:
* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.
|
|---|---|---|
|
Change From Baseline in the Total Nasal Symptom Score at 1 Week
|
-2.4686 score on a scale
Standard Error 0.1441
|
-1.1651 score on a scale
Standard Error 0.1967
|
Adverse Events
MFNS
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MFNS
n=220 participants at risk
Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
* 5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks.
|
Placebo
n=113 participants at risk
Placebo MFNS. Administration was as follows:
* 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.
* 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks.
|
|---|---|---|
|
Infections and infestations
Naspharyngitis
|
5.0%
11/220 • Number of events 11
|
8.8%
10/113 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.9%
13/220 • Number of events 15
|
9.7%
11/113 • Number of events 16
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial. The Sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
- Publication restrictions are in place
Restriction type: OTHER