Trial Outcomes & Findings for A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712) (NCT NCT01469234)
NCT ID: NCT01469234
Last Updated: 2015-03-11
Results Overview
The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
255 participants
Primary outcome timeframe
From time of sensitization (time 0) to end of visit (~8 hours)
Results posted on
2015-03-11
Participant Flow
Participant milestones
| Measure |
Loratadine
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
|---|---|---|---|
|
Overall Study
STARTED
|
85
|
85
|
85
|
|
Overall Study
COMPLETED
|
85
|
85
|
85
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
Baseline characteristics by cohort
| Measure |
Loratadine
n=85 Participants
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
n=85 Participants
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
n=85 Participants
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 13.52 • n=5 Participants
|
43.1 years
STANDARD_DEVIATION 12.21 • n=7 Participants
|
40.6 years
STANDARD_DEVIATION 12.56 • n=5 Participants
|
41.7 years
STANDARD_DEVIATION 12.77 • n=4 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
157 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
98 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From time of sensitization (time 0) to end of visit (~8 hours)Population: Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Loratadine
n=85 Participants
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
n=85 Participants
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
n=85 Participants
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
|---|---|---|---|
|
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
180 minutes (n=85, n=85, n=85)
|
7.4 units on a scale
Standard Deviation 4.51
|
6.7 units on a scale
Standard Deviation 4.86
|
8.5 units on a scale
Standard Deviation 5.07
|
|
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
195 minutes (n=85, n=85, n=85)
|
7.5 units on a scale
Standard Deviation 4.84
|
6.7 units on a scale
Standard Deviation 4.87
|
8.9 units on a scale
Standard Deviation 5.31
|
|
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
210 minutes (n=85, n=85, n=85)
|
7.3 units on a scale
Standard Deviation 4.73
|
6.5 units on a scale
Standard Deviation 4.87
|
8.7 units on a scale
Standard Deviation 5.28
|
|
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
225 minutes (n=85, n=85, n=85)
|
7.4 units on a scale
Standard Deviation 4.63
|
6.5 units on a scale
Standard Deviation 4.70
|
8.5 units on a scale
Standard Deviation 5.36
|
|
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
240 minutes (n=84, n=85, n=85)
|
7.4 units on a scale
Standard Deviation 4.76
|
6.5 units on a scale
Standard Deviation 4.43
|
8.3 units on a scale
Standard Deviation 5.38
|
|
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
255 minutes (n=85, n=85, n=85)
|
7.1 units on a scale
Standard Deviation 4.78
|
6.3 units on a scale
Standard Deviation 4.47
|
8.4 units on a scale
Standard Deviation 5.51
|
|
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
270 minutes (n=85, n=85, n=85)
|
7.0 units on a scale
Standard Deviation 4.67
|
6.4 units on a scale
Standard Deviation 4.50
|
8.4 units on a scale
Standard Deviation 5.56
|
|
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
285 minutes (n=85, n=85, n=85)
|
7.3 units on a scale
Standard Deviation 4.52
|
6.9 units on a scale
Standard Deviation 4.76
|
8.7 units on a scale
Standard Deviation 5.76
|
|
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
300 minutes (n=84, n=85, n=85)
|
7.1 units on a scale
Standard Deviation 4.54
|
6.5 units on a scale
Standard Deviation 4.65
|
8.4 units on a scale
Standard Deviation 5.58
|
SECONDARY outcome
Timeframe: From time of sensitization (time 0) to end of visit (~8 hours)Population: Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
The individual symptom score for Runny Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Loratadine
n=85 Participants
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
n=85 Participants
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
n=85 Participants
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
|---|---|---|---|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
0 minutes
|
3.4 units on a scale
Standard Deviation 0.77
|
3.2 units on a scale
Standard Deviation 0.78
|
3.3 units on a scale
Standard Deviation 0.89
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
15 minutes
|
3.1 units on a scale
Standard Deviation 0.85
|
3.0 units on a scale
Standard Deviation 0.91
|
3.0 units on a scale
Standard Deviation 1.09
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
30 minutes
|
3.0 units on a scale
Standard Deviation 0.95
|
2.9 units on a scale
Standard Deviation 0.99
|
2.9 units on a scale
Standard Deviation 1.14
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
45 minutes
|
2.8 units on a scale
Standard Deviation 0.99
|
2.6 units on a scale
Standard Deviation 1.05
|
2.8 units on a scale
Standard Deviation 1.15
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
60 minutes
|
2.7 units on a scale
Standard Deviation 1.06
|
2.3 units on a scale
Standard Deviation 1.02
|
2.7 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
75 minutes
|
2.6 units on a scale
Standard Deviation 1.06
|
2.2 units on a scale
Standard Deviation 1.08
|
2.6 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
90 minutes
|
2.4 units on a scale
Standard Deviation 1.04
|
2.1 units on a scale
Standard Deviation 1.08
|
2.4 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
105 minutes
|
2.4 units on a scale
Standard Deviation 1.10
|
2.1 units on a scale
Standard Deviation 1.03
|
2.5 units on a scale
Standard Deviation 1.16
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
120 minutes
|
2.1 units on a scale
Standard Deviation 1.07
|
2.0 units on a scale
Standard Deviation 1.00
|
2.3 units on a scale
Standard Deviation 1.18
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
135 minutes
|
2.2 units on a scale
Standard Deviation 1.12
|
2.0 units on a scale
Standard Deviation 1.07
|
2.4 units on a scale
Standard Deviation 1.19
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
150 minutes
|
2.3 units on a scale
Standard Deviation 1.10
|
2.0 units on a scale
Standard Deviation 1.07
|
2.4 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
165 minutes
|
2.2 units on a scale
Standard Deviation 1.07
|
1.8 units on a scale
Standard Deviation 1.14
|
2.3 units on a scale
Standard Deviation 1.18
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
180 minutes
|
2.1 units on a scale
Standard Deviation 1.20
|
1.9 units on a scale
Standard Deviation 1.20
|
2.3 units on a scale
Standard Deviation 1.17
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
195 minutes
|
2.1 units on a scale
Standard Deviation 1.27
|
1.9 units on a scale
Standard Deviation 1.21
|
2.4 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
210 minutes
|
2.0 units on a scale
Standard Deviation 1.23
|
1.8 units on a scale
Standard Deviation 1.22
|
2.3 units on a scale
Standard Deviation 1.24
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
225 minutes
|
2.1 units on a scale
Standard Deviation 1.22
|
1.8 units on a scale
Standard Deviation 1.24
|
2.3 units on a scale
Standard Deviation 1.19
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
240 minutes
|
2.0 units on a scale
Standard Deviation 1.23
|
1.8 units on a scale
Standard Deviation 1.19
|
2.2 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
255 minutes
|
2.0 units on a scale
Standard Deviation 1.30
|
1.7 units on a scale
Standard Deviation 1.15
|
2.3 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
270 minutes
|
1.9 units on a scale
Standard Deviation 1.30
|
1.8 units on a scale
Standard Deviation 1.10
|
2.3 units on a scale
Standard Deviation 1.35
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
285 minutes
|
2.1 units on a scale
Standard Deviation 1.24
|
1.9 units on a scale
Standard Deviation 1.15
|
2.3 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
300 minutes
|
2.0 units on a scale
Standard Deviation 1.26
|
1.8 units on a scale
Standard Deviation 1.14
|
2.3 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
315 minutes
|
2.1 units on a scale
Standard Deviation 1.25
|
1.8 units on a scale
Standard Deviation 1.17
|
2.4 units on a scale
Standard Deviation 1.30
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
330 minutes
|
2.2 units on a scale
Standard Deviation 1.26
|
1.8 units on a scale
Standard Deviation 1.18
|
2.3 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
345 minutes
|
2.1 units on a scale
Standard Deviation 1.27
|
1.8 units on a scale
Standard Deviation 1.17
|
2.4 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
360 minutes
|
2.1 units on a scale
Standard Deviation 1.29
|
1.9 units on a scale
Standard Deviation 1.23
|
2.3 units on a scale
Standard Deviation 1.33
|
SECONDARY outcome
Timeframe: From time of sensitization (time 0) to end of visit (~8 hours)Population: Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
The individual symptom score for Itchy Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Loratadine
n=85 Participants
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
n=85 Participants
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
n=85 Participants
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
|---|---|---|---|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
0 minutes
|
3.3 units on a scale
Standard Deviation 0.74
|
3.3 units on a scale
Standard Deviation 0.73
|
3.4 units on a scale
Standard Deviation 0.77
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
15 minutes
|
3.1 units on a scale
Standard Deviation 0.84
|
3.2 units on a scale
Standard Deviation 0.81
|
3.1 units on a scale
Standard Deviation 0.93
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
30 minutes
|
2.8 units on a scale
Standard Deviation 0.97
|
2.8 units on a scale
Standard Deviation 0.97
|
2.8 units on a scale
Standard Deviation 0.99
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
45 minutes
|
2.7 units on a scale
Standard Deviation 1.02
|
2.6 units on a scale
Standard Deviation 0.96
|
2.8 units on a scale
Standard Deviation 1.04
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
60 minutes
|
2.6 units on a scale
Standard Deviation 1.09
|
2.4 units on a scale
Standard Deviation 1.05
|
2.6 units on a scale
Standard Deviation 1.07
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
75 minutes
|
2.4 units on a scale
Standard Deviation 1.16
|
2.3 units on a scale
Standard Deviation 1.14
|
2.5 units on a scale
Standard Deviation 1.19
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
90 minutes
|
2.3 units on a scale
Standard Deviation 1.10
|
2.1 units on a scale
Standard Deviation 1.07
|
2.4 units on a scale
Standard Deviation 1.17
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
105 minutes
|
2.2 units on a scale
Standard Deviation 1.08
|
2.1 units on a scale
Standard Deviation 1.10
|
2.4 units on a scale
Standard Deviation 1.10
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
120 minutes
|
1.9 units on a scale
Standard Deviation 1.14
|
1.8 units on a scale
Standard Deviation 1.12
|
2.1 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
135 minutes
|
2.0 units on a scale
Standard Deviation 1.12
|
1.8 units on a scale
Standard Deviation 1.17
|
2.2 units on a scale
Standard Deviation 1.22
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
150 minutes
|
2.1 units on a scale
Standard Deviation 1.06
|
1.8 units on a scale
Standard Deviation 1.19
|
2.2 units on a scale
Standard Deviation 1.18
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
165 minutes
|
2.0 units on a scale
Standard Deviation 1.09
|
1.7 units on a scale
Standard Deviation 1.22
|
2.2 units on a scale
Standard Deviation 1.14
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
180 minutes
|
2.0 units on a scale
Standard Deviation 1.16
|
1.8 units on a scale
Standard Deviation 1.25
|
2.2 units on a scale
Standard Deviation 1.12
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
195 minutes
|
1.9 units on a scale
Standard Deviation 1.23
|
1.7 units on a scale
Standard Deviation 1.22
|
2.2 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
210 minutes
|
2.0 units on a scale
Standard Deviation 1.25
|
1.7 units on a scale
Standard Deviation 1.28
|
2.2 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
225 minutes
|
1.9 units on a scale
Standard Deviation 1.18
|
1.7 units on a scale
Standard Deviation 1.27
|
2.2 units on a scale
Standard Deviation 1.25
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
240 minutes
|
1.9 units on a scale
Standard Deviation 1.14
|
1.7 units on a scale
Standard Deviation 1.24
|
2.2 units on a scale
Standard Deviation 1.24
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
255 minutes
|
1.8 units on a scale
Standard Deviation 1.24
|
1.7 units on a scale
Standard Deviation 1.21
|
2.2 units on a scale
Standard Deviation 1.30
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
270 minutes
|
1.9 units on a scale
Standard Deviation 1.18
|
1.7 units on a scale
Standard Deviation 1.25
|
2.1 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
285 minutes
|
1.9 units on a scale
Standard Deviation 1.17
|
1.8 units on a scale
Standard Deviation 1.22
|
2.2 units on a scale
Standard Deviation 1.29
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
300 minutes
|
1.8 units on a scale
Standard Deviation 1.19
|
1.8 units on a scale
Standard Deviation 1.20
|
2.1 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
315 minutes
|
1.8 units on a scale
Standard Deviation 1.26
|
1.8 units on a scale
Standard Deviation 1.22
|
2.2 units on a scale
Standard Deviation 1.38
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
330 minutes
|
1.8 units on a scale
Standard Deviation 1.16
|
1.7 units on a scale
Standard Deviation 1.25
|
2.1 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
345 minutes
|
1.9 units on a scale
Standard Deviation 1.23
|
1.7 units on a scale
Standard Deviation 1.29
|
2.2 units on a scale
Standard Deviation 1.36
|
|
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
360 minutes
|
1.8 units on a scale
Standard Deviation 1.22
|
1.8 units on a scale
Standard Deviation 1.32
|
2.2 units on a scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: From time of sensitization (time 0) to end of visit (~8 hours)Population: Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
The individual symptom score for Sneezing was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Loratadine
n=85 Participants
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
n=85 Participants
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
n=85 Participants
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
|---|---|---|---|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
0 minutes (n=85, n=85, n=85)
|
1.3 units on a scale
Standard Deviation 1.37
|
1.2 units on a scale
Standard Deviation 1.36
|
1.5 units on a scale
Standard Deviation 1.40
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
15 minutes (n=85, n=85, n=85)
|
1.2 units on a scale
Standard Deviation 1.31
|
1.2 units on a scale
Standard Deviation 1.39
|
1.3 units on a scale
Standard Deviation 1.37
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
30 minutes (n=85, n=85, n=85)
|
1.2 units on a scale
Standard Deviation 1.34
|
1.1 units on a scale
Standard Deviation 1.32
|
1.2 units on a scale
Standard Deviation 1.38
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
45 minutes (n=85, n=85, n=85)
|
1.0 units on a scale
Standard Deviation 1.29
|
0.9 units on a scale
Standard Deviation 1.22
|
1.3 units on a scale
Standard Deviation 1.39
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
60 minutes (n=85, n=85, n=85)
|
1.1 units on a scale
Standard Deviation 1.21
|
0.7 units on a scale
Standard Deviation 1.12
|
1.2 units on a scale
Standard Deviation 1.36
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
75 minutes (n=85, n=85, n=85)
|
1.0 units on a scale
Standard Deviation 1.25
|
0.8 units on a scale
Standard Deviation 1.16
|
1.1 units on a scale
Standard Deviation 1.39
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
90 minutes (n=85, n=85, n=85)
|
0.7 units on a scale
Standard Deviation 1.12
|
0.6 units on a scale
Standard Deviation 1.07
|
1.0 units on a scale
Standard Deviation 1.37
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
105 minutes (n=85, n=85, n=85)
|
0.8 units on a scale
Standard Deviation 1.16
|
0.6 units on a scale
Standard Deviation 1.07
|
1.1 units on a scale
Standard Deviation 1.43
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
120 minutes (n=85, n=85, n=85)
|
0.5 units on a scale
Standard Deviation 0.88
|
0.5 units on a scale
Standard Deviation 1.04
|
0.9 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
135 minutes (n=85, n=85, n=85)
|
0.8 units on a scale
Standard Deviation 1.13
|
0.7 units on a scale
Standard Deviation 1.20
|
1.2 units on a scale
Standard Deviation 1.48
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
150 minutes (n=85, n=85, n=85)
|
0.9 units on a scale
Standard Deviation 1.22
|
0.6 units on a scale
Standard Deviation 1.14
|
1.1 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
165 minutes (n=85, n=85, n=85)
|
0.8 units on a scale
Standard Deviation 1.11
|
0.5 units on a scale
Standard Deviation 1.03
|
0.9 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
180 minutes (n=85, n=85, n=85)
|
0.7 units on a scale
Standard Deviation 1.08
|
0.6 units on a scale
Standard Deviation 1.11
|
0.9 units on a scale
Standard Deviation 1.30
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
195 minutes (n=85, n=85, n=85)
|
0.8 units on a scale
Standard Deviation 1.19
|
0.6 units on a scale
Standard Deviation 1.09
|
1.0 units on a scale
Standard Deviation 1.38
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
210 minutes (n=85, n=85, n=85)
|
0.7 units on a scale
Standard Deviation 1.07
|
0.5 units on a scale
Standard Deviation 1.03
|
1.0 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
225 minutes (n=85, n=85, n=85)
|
0.7 units on a scale
Standard Deviation 1.04
|
0.6 units on a scale
Standard Deviation 0.93
|
0.9 units on a scale
Standard Deviation 1.33
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
240 minutes (n=85, n=85, n=85)
|
0.7 units on a scale
Standard Deviation 1.09
|
0.5 units on a scale
Standard Deviation 1.04
|
0.9 units on a scale
Standard Deviation 1.29
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
255 minutes (n=85, n=85, n=85)
|
0.6 units on a scale
Standard Deviation 1.15
|
0.4 units on a scale
Standard Deviation 0.86
|
1.0 units on a scale
Standard Deviation 1.41
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
270 minutes (n=85, n=85, n=85)
|
0.6 units on a scale
Standard Deviation 1.13
|
0.5 units on a scale
Standard Deviation 1.00
|
1.0 units on a scale
Standard Deviation 1.40
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
285 minutes (n=85, n=85, n=85)
|
0.8 units on a scale
Standard Deviation 1.08
|
0.6 units on a scale
Standard Deviation 1.07
|
1.1 units on a scale
Standard Deviation 1.42
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
300 minutes (n=84, n=85, n=85)
|
0.7 units on a scale
Standard Deviation 1.02
|
0.5 units on a scale
Standard Deviation 0.95
|
0.9 units on a scale
Standard Deviation 1.34
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
315 minutes (n=84, n=85, n=85)
|
0.7 units on a scale
Standard Deviation 1.10
|
0.4 units on a scale
Standard Deviation 0.94
|
1.1 units on a scale
Standard Deviation 1.40
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
330 minutes (n=85, n=85, n=85)
|
0.7 units on a scale
Standard Deviation 1.02
|
0.6 units on a scale
Standard Deviation 1.03
|
1.0 units on a scale
Standard Deviation 1.38
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
345 minutes (n=84, n=85, n=85)
|
0.7 units on a scale
Standard Deviation 1.09
|
0.6 units on a scale
Standard Deviation 0.99
|
1.0 units on a scale
Standard Deviation 1.33
|
|
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
360 minutes (n=85, n=85, n=85)
|
0.6 units on a scale
Standard Deviation 1.12
|
0.6 units on a scale
Standard Deviation 1.09
|
1.0 units on a scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: From time of sensitization (time 0) to end of visit (~8 hours)Population: Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
The individual symptom score for Water Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Loratadine
n=85 Participants
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
n=85 Participants
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
n=85 Participants
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
|---|---|---|---|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
210 minutes
|
1.2 units on a scale
Standard Deviation 1.14
|
1.1 units on a scale
Standard Deviation 1.13
|
1.4 units on a scale
Standard Deviation 1.27
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
165 minutes
|
1.2 units on a scale
Standard Deviation 1.14
|
1.2 units on a scale
Standard Deviation 1.14
|
1.4 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
0 minutes
|
2.7 units on a scale
Standard Deviation 1.12
|
2.8 units on a scale
Standard Deviation 1.05
|
2.7 units on a scale
Standard Deviation 1.02
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
15 minutes
|
2.4 units on a scale
Standard Deviation 1.17
|
2.6 units on a scale
Standard Deviation 1.10
|
2.4 units on a scale
Standard Deviation 1.15
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
30 minutes
|
2.2 units on a scale
Standard Deviation 1.23
|
2.3 units on a scale
Standard Deviation 1.17
|
2.1 units on a scale
Standard Deviation 1.25
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
45 minutes
|
1.9 units on a scale
Standard Deviation 1.22
|
2.0 units on a scale
Standard Deviation 1.19
|
2.0 units on a scale
Standard Deviation 1.18
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
60 minutes
|
1.8 units on a scale
Standard Deviation 1.21
|
1.9 units on a scale
Standard Deviation 1.16
|
1.9 units on a scale
Standard Deviation 1.12
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
75 minutes
|
1.7 units on a scale
Standard Deviation 1.21
|
1.8 units on a scale
Standard Deviation 1.19
|
1.6 units on a scale
Standard Deviation 1.11
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
90 minutes
|
1.5 units on a scale
Standard Deviation 1.29
|
1.6 units on a scale
Standard Deviation 1.23
|
1.5 units on a scale
Standard Deviation 1.18
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
105 minutes
|
1.5 units on a scale
Standard Deviation 1.22
|
1.6 units on a scale
Standard Deviation 1.13
|
1.5 units on a scale
Standard Deviation 1.19
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
120 minutes
|
1.3 units on a scale
Standard Deviation 1.15
|
1.3 units on a scale
Standard Deviation 1.09
|
1.4 units on a scale
Standard Deviation 1.18
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
135 minutes
|
1.2 units on a scale
Standard Deviation 1.11
|
1.3 units on a scale
Standard Deviation 1.11
|
1.4 units on a scale
Standard Deviation 1.29
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
150 minutes
|
1.2 units on a scale
Standard Deviation 1.12
|
1.2 units on a scale
Standard Deviation 1.19
|
1.4 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
195 minutes
|
1.2 units on a scale
Standard Deviation 1.15
|
1.2 units on a scale
Standard Deviation 1.19
|
1.5 units on a scale
Standard Deviation 1.21
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
180 minutes
|
1.2 units on a scale
Standard Deviation 1.07
|
1.1 units on a scale
Standard Deviation 1.12
|
1.3 units on a scale
Standard Deviation 1.16
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
225 minutes
|
1.2 units on a scale
Standard Deviation 1.13
|
1.1 units on a scale
Standard Deviation 1.16
|
1.4 units on a scale
Standard Deviation 1.25
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
240 minutes
|
1.2 units on a scale
Standard Deviation 1.16
|
1.1 units on a scale
Standard Deviation 1.10
|
1.4 units on a scale
Standard Deviation 1.24
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
255 minutes
|
1.2 units on a scale
Standard Deviation 1.12
|
1.1 units on a scale
Standard Deviation 1.13
|
1.4 units on a scale
Standard Deviation 1.26
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
270 minutes
|
1.2 units on a scale
Standard Deviation 1.13
|
1.1 units on a scale
Standard Deviation 1.09
|
1.4 units on a scale
Standard Deviation 1.21
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
285 minutes
|
1.2 units on a scale
Standard Deviation 1.08
|
1.2 units on a scale
Standard Deviation 1.13
|
1.4 units on a scale
Standard Deviation 1.27
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
300 minutes
|
1.2 units on a scale
Standard Deviation 1.02
|
1.1 units on a scale
Standard Deviation 1.10
|
1.3 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
315 minutes
|
1.2 units on a scale
Standard Deviation 1.09
|
1.2 units on a scale
Standard Deviation 1.13
|
1.4 units on a scale
Standard Deviation 1.33
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
330 minutes
|
1.3 units on a scale
Standard Deviation 1.14
|
1.2 units on a scale
Standard Deviation 1.15
|
1.4 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
345 minutes
|
1.2 units on a scale
Standard Deviation 1.15
|
1.2 units on a scale
Standard Deviation 1.19
|
1.4 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
360 minutes
|
1.2 units on a scale
Standard Deviation 1.20
|
1.3 units on a scale
Standard Deviation 1.17
|
1.4 units on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: From time of sensitization (time 0) to end of visit (~8 hours)Population: Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
The individual symptom score for Itchy Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Loratadine
n=85 Participants
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
n=85 Participants
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
n=85 Participants
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
|---|---|---|---|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
345 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.23
|
1.4 units on a scale
Standard Deviation 1.27
|
1.8 units on a scale
Standard Deviation 1.38
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
360 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.34
|
1.4 units on a scale
Standard Deviation 1.25
|
1.7 units on a scale
Standard Deviation 1.37
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
0 minutes (n=85, n=85, n=85)
|
3.0 units on a scale
Standard Deviation 0.93
|
3.2 units on a scale
Standard Deviation 0.87
|
3.1 units on a scale
Standard Deviation 1.08
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
15 minutes (n=85, n=85, n=84)
|
2.6 units on a scale
Standard Deviation 1.10
|
3.0 units on a scale
Standard Deviation 1.02
|
2.8 units on a scale
Standard Deviation 1.15
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
30 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.12
|
2.7 units on a scale
Standard Deviation 1.17
|
2.4 units on a scale
Standard Deviation 1.20
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
45 minutes (n=85, n=85, n=85)
|
2.2 units on a scale
Standard Deviation 1.14
|
2.3 units on a scale
Standard Deviation 1.17
|
2.4 units on a scale
Standard Deviation 1.24
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
60 minutes (n=85, n=85, n=85)
|
1.9 units on a scale
Standard Deviation 1.14
|
2.1 units on a scale
Standard Deviation 1.14
|
2.2 units on a scale
Standard Deviation 1.23
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
75 minutes (n=85, n=85, n=85)
|
1.9 units on a scale
Standard Deviation 1.14
|
2.0 units on a scale
Standard Deviation 1.20
|
1.9 units on a scale
Standard Deviation 1.25
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
90 minutes (n=85, n=85, n=85)
|
1.8 units on a scale
Standard Deviation 1.21
|
1.8 units on a scale
Standard Deviation 1.17
|
1.9 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
105 minutes (n=85, n=85, n=85)
|
1.8 units on a scale
Standard Deviation 1.18
|
1.8 units on a scale
Standard Deviation 1.15
|
1.8 units on a scale
Standard Deviation 1.29
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
120 minutes (n=85, n=85, n=85)
|
1.6 units on a scale
Standard Deviation 1.19
|
1.6 units on a scale
Standard Deviation 1.14
|
1.7 units on a scale
Standard Deviation 1.30
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
135 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.14
|
1.5 units on a scale
Standard Deviation 1.13
|
1.7 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
150 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.06
|
1.4 units on a scale
Standard Deviation 1.20
|
1.6 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
165 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.11
|
1.4 units on a scale
Standard Deviation 1.24
|
1.7 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
180 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.11
|
1.4 units on a scale
Standard Deviation 1.18
|
1.7 units on a scale
Standard Deviation 1.23
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
195 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.15
|
1.4 units on a scale
Standard Deviation 1.19
|
1.8 units on a scale
Standard Deviation 1.30
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
210 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.12
|
1.4 units on a scale
Standard Deviation 1.21
|
1.7 units on a scale
Standard Deviation 1.26
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
225 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.15
|
1.4 units on a scale
Standard Deviation 1.19
|
1.7 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
240 minutes (n=84, n=85, n=85)
|
1.6 units on a scale
Standard Deviation 1.19
|
1.4 units on a scale
Standard Deviation 1.11
|
1.7 units on a scale
Standard Deviation 1.29
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
255 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.13
|
1.4 units on a scale
Standard Deviation 1.18
|
1.6 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
270 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.09
|
1.4 units on a scale
Standard Deviation 1.15
|
1.6 units on a scale
Standard Deviation 1.30
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
285 minutes (n=85, n=85, n=85)
|
1.3 units on a scale
Standard Deviation 1.16
|
1.4 units on a scale
Standard Deviation 1.17
|
1.7 units on a scale
Standard Deviation 1.42
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
300 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.19
|
1.4 units on a scale
Standard Deviation 1.18
|
1.7 units on a scale
Standard Deviation 1.33
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
315 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.19
|
1.4 units on a scale
Standard Deviation 1.24
|
1.7 units on a scale
Standard Deviation 1.36
|
|
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
330 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.21
|
1.4 units on a scale
Standard Deviation 1.24
|
1.6 units on a scale
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: From time of sensitization (time 0) to end of visit (~8 hours)Population: Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
The individual symptom score for Nasal Congestion was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Loratadine
n=85 Participants
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
n=85 Participants
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
n=85 Participants
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
|---|---|---|---|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
0 minutes (n=85, n=85, n=85)
|
3.4 units on a scale
Standard Deviation 0.81
|
3.2 units on a scale
Standard Deviation 0.88
|
3.4 units on a scale
Standard Deviation 0.76
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
15 minutes (n=85, n=85, n=85)
|
2.5 units on a scale
Standard Deviation 1.20
|
2.2 units on a scale
Standard Deviation 1.25
|
2.7 units on a scale
Standard Deviation 1.19
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
30 minutes (n=85, n=85, n=85)
|
1.6 units on a scale
Standard Deviation 1.33
|
1.5 units on a scale
Standard Deviation 1.19
|
2.0 units on a scale
Standard Deviation 1.26
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
45 minutes (n=85, n=85, n=85)
|
2.5 units on a scale
Standard Deviation 1.16
|
2.1 units on a scale
Standard Deviation 1.21
|
2.6 units on a scale
Standard Deviation 1.22
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
60 minutes (n=85, n=85, n=85)
|
1.6 units on a scale
Standard Deviation 1.29
|
1.4 units on a scale
Standard Deviation 1.20
|
1.8 units on a scale
Standard Deviation 1.34
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
75 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.25
|
2.1 units on a scale
Standard Deviation 1.21
|
2.6 units on a scale
Standard Deviation 1.24
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
90 minutes (n=85, n=85, n=85)
|
1.6 units on a scale
Standard Deviation 1.27
|
1.3 units on a scale
Standard Deviation 1.19
|
1.8 units on a scale
Standard Deviation 1.34
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
105 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.24
|
2.1 units on a scale
Standard Deviation 1.20
|
2.6 units on a scale
Standard Deviation 1.24
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
120 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.26
|
1.4 units on a scale
Standard Deviation 1.17
|
1.8 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
135 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.24
|
2.1 units on a scale
Standard Deviation 1.19
|
2.6 units on a scale
Standard Deviation 1.26
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
150 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.31
|
1.3 units on a scale
Standard Deviation 1.19
|
1.8 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
165 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.26
|
2.0 units on a scale
Standard Deviation 1.14
|
2.5 units on a scale
Standard Deviation 1.33
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
180 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.22
|
1.3 units on a scale
Standard Deviation 1.22
|
1.8 units on a scale
Standard Deviation 1.39
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
195 minutes (n=85, n=85, n=85)
|
2.5 units on a scale
Standard Deviation 1.21
|
2.0 units on a scale
Standard Deviation 1.15
|
2.6 units on a scale
Standard Deviation 1.25
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
210 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.31
|
1.3 units on a scale
Standard Deviation 1.20
|
1.8 units on a scale
Standard Deviation 1.34
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
225 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.21
|
2.0 units on a scale
Standard Deviation 1.24
|
2.6 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
240 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.29
|
1.4 units on a scale
Standard Deviation 1.21
|
1.8 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
255 minutes (n=85, n=85, n=84)
|
2.4 units on a scale
Standard Deviation 1.26
|
2.0 units on a scale
Standard Deviation 1.19
|
2.6 units on a scale
Standard Deviation 1.30
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
270 minutes (n=85, n=85, n=84)
|
1.6 units on a scale
Standard Deviation 1.29
|
1.3 units on a scale
Standard Deviation 1.22
|
1.8 units on a scale
Standard Deviation 1.46
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
285 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.31
|
2.1 units on a scale
Standard Deviation 1.19
|
2.6 units on a scale
Standard Deviation 1.34
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
300 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.31
|
1.3 units on a scale
Standard Deviation 1.25
|
1.8 units on a scale
Standard Deviation 1.43
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
315 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.29
|
2.1 units on a scale
Standard Deviation 1.19
|
2.5 units on a scale
Standard Deviation 1.39
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
330 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.31
|
1.3 units on a scale
Standard Deviation 1.24
|
1.8 units on a scale
Standard Deviation 1.47
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
345 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.28
|
2.0 units on a scale
Standard Deviation 1.24
|
2.5 units on a scale
Standard Deviation 1.33
|
|
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
360 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.31
|
1.4 units on a scale
Standard Deviation 1.31
|
1.9 units on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: From time of sensitization (time 0) to end of visit (~8 hours)Population: Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Outcome measures
| Measure |
Loratadine
n=85 Participants
Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
|
Fexofenadine
n=85 Participants
Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
|
Placebo
n=85 Participants
Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
|
|---|---|---|---|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
0 minutes (n=85, n=85, n=85)
|
3.0 units on a scale
Standard Deviation 1.08
|
3.0 units on a scale
Standard Deviation 1.05
|
2.9 units on a scale
Standard Deviation 1.17
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
15 minutes (n=85, n=85, n=85)
|
3.2 units on a scale
Standard Deviation 1.05
|
3.0 units on a scale
Standard Deviation 1.06
|
3.0 units on a scale
Standard Deviation 1.09
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
30 minutes (n=85, n=85, n=85)
|
2.6 units on a scale
Standard Deviation 1.19
|
2.8 units on a scale
Standard Deviation 1.17
|
2.6 units on a scale
Standard Deviation 1.27
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
45 minutes (n=85, n=85, n=85)
|
3.0 units on a scale
Standard Deviation 1.11
|
2.8 units on a scale
Standard Deviation 1.09
|
2.8 units on a scale
Standard Deviation 1.06
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
60 minutes (n=85, n=85, n=85)
|
2.3 units on a scale
Standard Deviation 1.29
|
2.6 units on a scale
Standard Deviation 1.27
|
2.4 units on a scale
Standard Deviation 1.25
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
75 minutes (n=85, n=85, n=85)
|
2.8 units on a scale
Standard Deviation 1.16
|
2.6 units on a scale
Standard Deviation 1.16
|
2.8 units on a scale
Standard Deviation 1.12
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
90 minutes (n=85, n=85, n=85)
|
2.0 units on a scale
Standard Deviation 1.22
|
2.3 units on a scale
Standard Deviation 1.16
|
2.3 units on a scale
Standard Deviation 1.25
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
105 minutes (n=85, n=85, n=85)
|
2.7 units on a scale
Standard Deviation 1.19
|
2.4 units on a scale
Standard Deviation 1.17
|
2.6 units on a scale
Standard Deviation 1.14
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
120 minutes (n=85, n=85, n=85)
|
1.9 units on a scale
Standard Deviation 1.24
|
2.0 units on a scale
Standard Deviation 1.15
|
2.1 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
135 minutes (n=85, n=85, n=85)
|
2.6 units on a scale
Standard Deviation 1.20
|
2.3 units on a scale
Standard Deviation 1.24
|
2.5 units on a scale
Standard Deviation 1.24
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
150 minutes (n=85, n=85, n=85)
|
1.8 units on a scale
Standard Deviation 1.21
|
1.8 units on a scale
Standard Deviation 1.17
|
1.9 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
165 minutes (n=85, n=85, n=85)
|
2.5 units on a scale
Standard Deviation 1.17
|
2.2 units on a scale
Standard Deviation 1.21
|
2.4 units on a scale
Standard Deviation 1.29
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
180 minutes (n=85, n=85, n=85)
|
1.7 units on a scale
Standard Deviation 1.20
|
1.7 units on a scale
Standard Deviation 1.21
|
1.8 units on a scale
Standard Deviation 1.29
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
195 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.25
|
2.1 units on a scale
Standard Deviation 1.17
|
2.4 units on a scale
Standard Deviation 1.26
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
210 minutes (n=85, n=85, n=85)
|
1.6 units on a scale
Standard Deviation 1.21
|
1.7 units on a scale
Standard Deviation 1.12
|
1.9 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
225 minutes (n=85, n=85, n=85)
|
2.3 units on a scale
Standard Deviation 1.13
|
2.0 units on a scale
Standard Deviation 1.20
|
2.3 units on a scale
Standard Deviation 1.25
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
240 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.18
|
1.5 units on a scale
Standard Deviation 1.15
|
1.7 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
255 minutes (n=85, n=85, n=84)
|
2.3 units on a scale
Standard Deviation 1.19
|
2.0 units on a scale
Standard Deviation 1.22
|
2.4 units on a scale
Standard Deviation 1.28
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
270 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.20
|
1.6 units on a scale
Standard Deviation 1.16
|
1.7 units on a scale
Standard Deviation 1.29
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
285 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.16
|
2.0 units on a scale
Standard Deviation 1.26
|
2.4 units on a scale
Standard Deviation 1.31
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
300 minutes (n=85, n=85, n=85)
|
1.5 units on a scale
Standard Deviation 1.14
|
1.4 units on a scale
Standard Deviation 1.21
|
1.8 units on a scale
Standard Deviation 1.32
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
315 minutes (n=85, n=85, n=85)
|
2.4 units on a scale
Standard Deviation 1.18
|
2.0 units on a scale
Standard Deviation 1.23
|
2.4 units on a scale
Standard Deviation 1.30
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
330 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.19
|
1.4 units on a scale
Standard Deviation 1.22
|
1.7 units on a scale
Standard Deviation 1.23
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
345 minutes (n=85, n=85, n=85)
|
2.3 units on a scale
Standard Deviation 1.20
|
2.0 units on a scale
Standard Deviation 1.25
|
2.5 units on a scale
Standard Deviation 1.29
|
|
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
360 minutes (n=85, n=85, n=85)
|
1.4 units on a scale
Standard Deviation 1.17
|
1.3 units on a scale
Standard Deviation 1.21
|
1.7 units on a scale
Standard Deviation 1.27
|
Adverse Events
Loratadine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fexofenadine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place