Trial Outcomes & Findings for A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512) (NCT NCT00783224)
NCT ID: NCT00783224
Last Updated: 2022-02-09
Results Overview
The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
351 participants
Primary outcome timeframe
Baseline to 2 weeks of treatment
Results posted on
2022-02-09
Participant Flow
Participant milestones
| Measure |
Mometasone Furoate Placebo (PLAMF)
Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
|
Fluticasone Propionate Placebo (PLAFP)
Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
|
Mometasone Furoate (MF)
Mometasone furoate nasal spray 200 μg/day(QD)
|
Fluticasone Propionate (FP)
Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
143
|
142
|
|
Overall Study
COMPLETED
|
32
|
34
|
142
|
140
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Mometasone Furoate Placebo (PLAMF)
Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
|
Fluticasone Propionate Placebo (PLAFP)
Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
|
Mometasone Furoate (MF)
Mometasone furoate nasal spray 200 μg/day(QD)
|
Fluticasone Propionate (FP)
Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
|
Overall Study
Discarded the Investigational Drug Used
|
0
|
0
|
0
|
1
|
|
Overall Study
Inappropriate as a study subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)
Baseline characteristics by cohort
| Measure |
Mometasone Furoate Placebo (PLAMF)
n=32 Participants
Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
|
Fluticasone Propionate Placebo (PLAFP)
n=34 Participants
Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
|
Mometasone Furoate (MF)
n=143 Participants
Mometasone furoate nasal spray 200 μg/day(QD)
|
Fluticasone Propionate (FP)
n=142 Participants
Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
|
Total
n=351 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
<20 years old
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
7 participants
n=5 Participants
|
11 participants
n=4 Participants
|
19 participants
n=21 Participants
|
|
Age, Customized
20-29 years old
|
20 participants
n=5 Participants
|
13 participants
n=7 Participants
|
59 participants
n=5 Participants
|
76 participants
n=4 Participants
|
168 participants
n=21 Participants
|
|
Age, Customized
30-39 years old
|
11 participants
n=5 Participants
|
16 participants
n=7 Participants
|
54 participants
n=5 Participants
|
33 participants
n=4 Participants
|
114 participants
n=21 Participants
|
|
Age, Customized
40-59 years old
|
0 participants
n=5 Participants
|
5 participants
n=7 Participants
|
19 participants
n=5 Participants
|
21 participants
n=4 Participants
|
45 participants
n=21 Participants
|
|
Age, Customized
>=60 years old
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
4 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
230 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
121 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to 2 weeks of treatmentThe nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points.
Outcome measures
| Measure |
Mometasone Furoate Placebo (PLAMF)
n=32 Participants
Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray
|
Fluticasone Propionate Placebo (PLAFP)
n=34 Participants
Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
|
Mometasone Furoate (MF)
n=143 Participants
Mometasone furoate nasal spray 200 μg/day(QD)
|
Fluticasone Propionate (FP)
n=142 Participants
Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
|
|---|---|---|---|---|
|
Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks
Baseline
|
7.84 Units on a scale
Standard Error 0.25
|
8.41 Units on a scale
Standard Error 0.29
|
8.27 Units on a scale
Standard Error 0.15
|
8.29 Units on a scale
Standard Error 0.16
|
|
Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks
Two Weeks
|
1.63 Units on a scale
Standard Error 0.37
|
1.74 Units on a scale
Standard Error 0.35
|
3.90 Units on a scale
Standard Error 0.17
|
3.69 Units on a scale
Standard Error 0.17
|
Adverse Events
Mometasone Furoate Placebo and Fluticasone Propionate Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Mometasone Furoate (MF)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Fluticasone Propionate (FP)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mometasone Furoate Placebo and Fluticasone Propionate Placebo
n=66 participants at risk
Both placebo groups (arms) were combined to report adverse events
|
Mometasone Furoate (MF)
n=143 participants at risk
Mometasone furoate nasal spray 200 μg/day(QD)
|
Fluticasone Propionate (FP)
n=142 participants at risk
Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
|
|---|---|---|---|
|
Surgical and medical procedures
Wisdom Teeth Removal
|
0.00%
0/66
|
0.00%
0/143
|
0.70%
1/142 • Number of events 1
|
Other adverse events
| Measure |
Mometasone Furoate Placebo and Fluticasone Propionate Placebo
n=66 participants at risk
Both placebo groups (arms) were combined to report adverse events
|
Mometasone Furoate (MF)
n=143 participants at risk
Mometasone furoate nasal spray 200 μg/day(QD)
|
Fluticasone Propionate (FP)
n=142 participants at risk
Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID)
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
6.1%
4/66 • Number of events 4
|
7.7%
11/143 • Number of events 11
|
2.8%
4/142 • Number of events 4
|
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 only restriction on the PI is that the PI needs to get approval from the sponsor for publication of the trial results prior to public release.
- Publication restrictions are in place
Restriction type: OTHER