Trial Outcomes & Findings for Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145) (NCT NCT03855228)
NCT ID: NCT03855228
Last Updated: 2022-02-09
Results Overview
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
COMPLETED
PHASE3
704 participants
Baseline and days 1 through 15 (average of 15 days of treatment)
2022-02-09
Participant Flow
Participant milestones
| Measure |
MFNS 200 μg + Loratadine 10 mg
Daily administration of 200 μg of Mometasone Furoate Nasal Spray (MFNS) plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
169
|
176
|
182
|
177
|
|
Overall Study
Treated
|
169
|
176
|
181
|
176
|
|
Overall Study
COMPLETED
|
166
|
167
|
174
|
158
|
|
Overall Study
NOT COMPLETED
|
3
|
9
|
8
|
19
|
Reasons for withdrawal
| Measure |
MFNS 200 μg + Loratadine 10 mg
Daily administration of 200 μg of Mometasone Furoate Nasal Spray (MFNS) plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
4
|
4
|
8
|
|
Overall Study
Treatment Failure
|
1
|
2
|
1
|
8
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
2
|
1
|
|
Overall Study
Did Not Meet Entry Requirements
|
0
|
2
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)
Baseline characteristics by cohort
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=169 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=176 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=181 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=176 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
Total
n=702 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
25.6 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
25.6 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
25.2 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
25.6 Years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
25.5 Years
STANDARD_DEVIATION 13.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
350 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
84 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
91 Participants
n=4 Participants
|
352 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
162 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
169 Participants
n=4 Participants
|
672 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
150 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
154 Participants
n=4 Participants
|
622 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline and days 1 through 15 (average of 15 days of treatment)Population: Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=165 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=166 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=175 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=165 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)
Baseline
|
7.9 Score on a scale
Standard Deviation 2.2
|
7.8 Score on a scale
Standard Deviation 2.2
|
7.9 Score on a scale
Standard Deviation 2.2
|
8.0 Score on a scale
Standard Deviation 2.1
|
|
Change From Baseline in Total Nasal Symptom Score (Assessed by Participant)
Change From Baseline Days 1-15
|
-3.0 Score on a scale
Standard Deviation 2.6
|
-2.7 Score on a scale
Standard Deviation 2.5
|
-1.9 Score on a scale
Standard Deviation 2.2
|
-1.4 Score on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Baseline and days 1 through 15 (average of 15 days of treatment)Population: Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=165 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=166 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=175 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=165 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Change From Baseline in Total Symptom Score (Assessed by Participant)
Baseline
|
14.3 Score on a scale
Standard Deviation 4.1
|
14.2 Score on a scale
Standard Deviation 4.4
|
14.4 Score on a scale
Standard Deviation 4.5
|
14.6 Score on a scale
Standard Deviation 4.3
|
|
Change From Baseline in Total Symptom Score (Assessed by Participant)
Change From Baseline Days 1-15
|
-5.4 Score on a scale
Standard Deviation 4.8
|
-4.8 Score on a scale
Standard Deviation 4.7
|
-3.8 Score on a scale
Standard Deviation 4.2
|
-2.7 Score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: Baseline and study day 15Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=165 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=164 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=172 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=162 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)
Baseline
|
8.7 Score on a scale
Standard Deviation 1.8
|
8.6 Score on a scale
Standard Deviation 1.8
|
8.6 Score on a scale
Standard Deviation 1.7
|
8.8 Score on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician)
Change From Baseline Day 15
|
-4.4 Score on a scale
Standard Deviation 3.1
|
-4.2 Score on a scale
Standard Deviation 2.8
|
-3.1 Score on a scale
Standard Deviation 2.8
|
-2.8 Score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline and study day 15Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=165 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=164 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=172 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=162 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)
Baseline
|
15.9 Score on a scale
Standard Deviation 3.1
|
16.1 Score on a scale
Standard Deviation 3.4
|
15.9 Score on a scale
Standard Deviation 3.2
|
16.2 Score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician)
Change From Baseline Day 15
|
-8.2 Score on a scale
Standard Deviation 5.3
|
-8.0 Score on a scale
Standard Deviation 5.1
|
-6.2 Score on a scale
Standard Deviation 5.1
|
-5.4 Score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline and study day 8Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=165 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=164 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=172 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=162 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)
Baseline
|
8.7 Score on a scale
Standard Deviation 1.8
|
8.6 Score on a scale
Standard Deviation 1.8
|
8.6 Score on a scale
Standard Deviation 1.7
|
8.8 Score on a scale
Standard Deviation 1.8
|
|
Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician)
Change From Baseline Day 8
|
-3.7 Score on a scale
Standard Deviation 3.1
|
-3.6 Score on a scale
Standard Deviation 2.7
|
-2.6 Score on a scale
Standard Deviation 2.6
|
-2.2 Score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline and study day 8Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=165 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=164 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=172 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=162 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)
Baseline
|
15.9 Score on a scale
Standard Deviation 3.1
|
16.1 Score on a scale
Standard Deviation 3.4
|
15.9 Score on a scale
Standard Deviation 3.2
|
16.2 Score on a scale
Standard Deviation 3.5
|
|
Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician)
Change From Baseline Day 8
|
-7.0 Score on a scale
Standard Deviation 5.4
|
-6.9 Score on a scale
Standard Deviation 4.9
|
-5.2 Score on a scale
Standard Deviation 4.6
|
-4.6 Score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: Baseline and study day 15Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=165 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=164 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=172 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=162 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)
Baseline
|
2.3 Score on a scale
Standard Deviation 0.5
|
2.3 Score on a scale
Standard Deviation 0.5
|
2.3 Score on a scale
Standard Deviation 0.5
|
2.3 Score on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician)
Change From Baseline Day 15
|
-0.9 Score on a scale
Standard Deviation 0.7
|
-0.9 Score on a scale
Standard Deviation 0.7
|
-0.6 Score on a scale
Standard Deviation 0.8
|
-0.6 Score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline and study day 8Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=165 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=164 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=172 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=162 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)
Baseline
|
2.3 Score on a scale
Standard Deviation 0.5
|
2.3 Score on a scale
Standard Deviation 0.5
|
2.3 Score on a scale
Standard Deviation 0.5
|
2.3 Score on a scale
Standard Deviation 0.5
|
|
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician)
Change From Baseline Day 8
|
-0.8 Score on a scale
Standard Deviation 0.8
|
-0.7 Score on a scale
Standard Deviation 0.7
|
-0.5 Score on a scale
Standard Deviation 0.7
|
-0.5 Score on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Study day 15Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=160 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=159 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=167 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=154 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Response to Therapy on Day 15 (Assessed by Physician)
|
2.8 Score on a scale
Standard Deviation 1.0
|
3.0 Score on a scale
Standard Deviation 1.0
|
3.4 Score on a scale
Standard Deviation 1.1
|
3.4 Score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Study day 8Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.
Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response.
Outcome measures
| Measure |
MFNS 200 μg + Loratadine 10 mg
n=165 Participants
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200 μg
n=163 Participants
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine 10 mg
n=172 Participants
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=162 Participants
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Response to Therapy on Day 8 (Assessed by Physician)
|
3.0 Score on a scale
Standard Deviation 1.1
|
3.1 Score on a scale
Standard Deviation 1.0
|
3.4 Score on a scale
Standard Deviation 0.9
|
3.6 Score on a scale
Standard Deviation 1.0
|
Adverse Events
MFNS Pus Loratadine
MFNS 200
Loratadine
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
MFNS Pus Loratadine
n=169 participants at risk
Daily administration of 200 μg of MFNS plus oral dose of 10 mg loratadine tablet.
|
MFNS 200
n=176 participants at risk
Daily administration of 200 μg of MFNS plus oral placebo tablet.
|
Loratadine
n=181 participants at risk
Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray.
|
Placebo
n=176 participants at risk
Daily administration of placebo nasal spray plus oral placebo tablet.
|
|---|---|---|---|---|
|
Nervous system disorders
HEADACHE
|
13.0%
22/169 • Number of events 35 • Up to approximately 45 days.
Analysis population includes all randomized participants with at least one post-Baseline evaluation. Adverse event (AE) preferred terms were converted from WHO-ART dictionary to the MedDRA version 12.0.
|
12.5%
22/176 • Number of events 28 • Up to approximately 45 days.
Analysis population includes all randomized participants with at least one post-Baseline evaluation. Adverse event (AE) preferred terms were converted from WHO-ART dictionary to the MedDRA version 12.0.
|
18.2%
33/181 • Number of events 41 • Up to approximately 45 days.
Analysis population includes all randomized participants with at least one post-Baseline evaluation. Adverse event (AE) preferred terms were converted from WHO-ART dictionary to the MedDRA version 12.0.
|
11.9%
21/176 • Number of events 31 • Up to approximately 45 days.
Analysis population includes all randomized participants with at least one post-Baseline evaluation. Adverse event (AE) preferred terms were converted from WHO-ART dictionary to the MedDRA version 12.0.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator agrees not to publish or publicly present any interim results of the Protocol study without the prior written consent of Sponsor. The Principal Investigator further agrees to provide thirty (30) days prior to submission for publication or presentation to Sponsor to review copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the Protocol study.
- Publication restrictions are in place
Restriction type: OTHER