Trial Outcomes & Findings for Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529) (NCT NCT00732381)
NCT ID: NCT00732381
Last Updated: 2024-05-21
Results Overview
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours \[reflective\])
COMPLETED
PHASE3
351 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
|
176
|
175
|
|
Overall Study
COMPLETED
|
174
|
174
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
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
|
1
|
0
|
|
Overall Study
Treatment Failure
|
1
|
1
|
Baseline Characteristics
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529)
Baseline characteristics by cohort
| Measure |
Mometasone Furoate Nasal Spray
n=176 Participants
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
Placebo Nasal Spray
n=175 Participants
Matching placebo nasal spray
|
Total
n=351 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
162 Participants
n=99 Participants
|
156 Participants
n=107 Participants
|
318 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
107 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
223 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
128 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 15 days of treatmentPopulation: The standard deviation is pooled.
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours \[reflective\])
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray
n=176 Participants
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
Placebo Nasal Spray
n=175 Participants
Matching placebo nasal spray
|
|---|---|---|
|
The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
|
-0.64 Units on a scale
Standard Deviation 0.52
|
-0.49 Units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: 15 days of treatmentTotal 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. PRIOR (the subject's status over the previous 12 hours \[reflective\])
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray
n=176 Participants
Mometasone furoate nasal spray 200 mcg QD (once per day)
|
Placebo Nasal Spray
n=175 Participants
Matching placebo nasal spray
|
|---|---|---|
|
The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
|
-2.68 Units on a scale
Standard Deviation 2.01
|
-1.85 Units on a scale
Standard Deviation 2.01
|
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: LTE60