Trial Outcomes & Findings for Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED) (NCT NCT00733005)
NCT ID: NCT00733005
Last Updated: 2024-05-21
Results Overview
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\])
COMPLETED
PHASE3
324 participants
15 days of treatment
2024-05-21
Participant Flow
Participant milestones
| Measure |
Mometasone Furoate Nasal Spray
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
Placebo Nasal Spray
Matching placebo nasal spray
|
|---|---|---|
|
Overall Study
STARTED
|
162
|
162
|
|
Overall Study
COMPLETED
|
160
|
159
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Mometasone Furoate Nasal Spray
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
Placebo Nasal Spray
Matching placebo nasal spray
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Treatment Failure
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Mometasone Furoate Nasal Spray
n=162 Participants
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
Placebo Nasal Spray
n=162 Participants
Matching placebo nasal spray
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
148 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
229 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 days of treatmentPopulation: Standard deviation is pooled.
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\])
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray
n=162 Participants
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
Placebo Nasal Spray
n=162 Participants
Matching placebo nasal spray
|
|---|---|---|
|
The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.
|
-0.68 Units on a scale
Standard Deviation 0.59
|
-0.57 Units on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: 15 days of treatmentPopulation: Standard deviation is pooled.
Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray
n=162 Participants
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
Placebo Nasal Spray
n=162 Participants
Matching placebo nasal spray
|
|---|---|---|
|
The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
|
-2.61 Units on a scale
Standard Deviation 2.10
|
-2.06 Units on a scale
Standard Deviation 2.10
|
Adverse Events
Mometasone Furoate Nasal Spray
Placebo Nasal Spray
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck, Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60