Rhinitis
Conditions
Brief summary
The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.
Interventions
loratadine, one 10 mg tablet, orally
fexofenadine, one 180 mg tablet, orally
one tablet, orally
one tablet, orally
Sponsors
Study design
Eligibility
Inclusion criteria
* Female participants of child bearing potential must demonstrate a negative urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study. * Willing to stop use of current decongestant and allergy medications at the start of the washout period (Visit 1) and during the trial. * Documented history or participant-reported history of seasonal allergic rhinitis caused by mountain cedar pollen within the last 2 years and documented or participant-reported symptoms over at least the last 2 mountain cedar allergy seasons. * Documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the last 1 year to mountain cedar pollen present. * Capable of reading English. * Body mass index (BMI) \<35.
Exclusion criteria
* Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, fexofenadine or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy. * Have started allergen immunotherapy within 1 month preceding enrollment or participants starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation. * Known allergy or intolerance to loratadine, desloratadine, or fexofenadine. * History of rhinitis medicamentosa. * Use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone is permitted), or nasal corticosteroids in the last 30 days or current or expected use of disallowed medications as listed in the protocol. * Asthma, with the exception of mild intermittent asthma.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | From time of sensitization (time 0) to end of visit (~8 hours) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | 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. |
| Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | 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. |
| Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | 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. |
| Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | 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. |
| Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | 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. |
| Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | 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. |
| Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Loratadine Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. | 85 |
| Fexofenadine Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. | 85 |
| Placebo Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4. | 85 |
| Total | 255 |
Baseline characteristics
| Characteristic | Loratadine | Fexofenadine | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 41.5 years STANDARD_DEVIATION 13.52 | 43.1 years STANDARD_DEVIATION 12.21 | 40.6 years STANDARD_DEVIATION 12.56 | 41.7 years STANDARD_DEVIATION 12.77 |
| Sex: Female, Male Female | 51 Participants | 53 Participants | 53 Participants | 157 Participants |
| Sex: Female, Male Male | 34 Participants | 32 Participants | 32 Participants | 98 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 85 | 0 / 85 | 0 / 85 |
| serious Total, serious adverse events | 0 / 85 | 0 / 85 | 0 / 85 |
Outcome results
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Fexofenadine | 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) | 6.5 units on a scale | Standard Deviation 4.43 |
| Fexofenadine | 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) | 6.7 units on a scale | Standard Deviation 4.86 |
| Fexofenadine | 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) | 6.7 units on a scale | Standard Deviation 4.87 |
| Fexofenadine | 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) | 6.5 units on a scale | Standard Deviation 4.87 |
| Fexofenadine | 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) | 6.5 units on a scale | Standard Deviation 4.7 |
| Fexofenadine | 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) | 6.3 units on a scale | Standard Deviation 4.47 |
| Fexofenadine | 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) | 6.4 units on a scale | Standard Deviation 4.5 |
| Fexofenadine | 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) | 6.9 units on a scale | Standard Deviation 4.76 |
| Fexofenadine | 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) | 6.5 units on a scale | Standard Deviation 4.65 |
| Placebo | 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) | 8.7 units on a scale | Standard Deviation 5.28 |
| Placebo | 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) | 8.5 units on a scale | Standard Deviation 5.07 |
| Placebo | 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) | 8.4 units on a scale | Standard Deviation 5.56 |
| Placebo | 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) | 8.9 units on a scale | Standard Deviation 5.31 |
| Placebo | 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) | 8.4 units on a scale | Standard Deviation 5.58 |
| Placebo | 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) | 8.3 units on a scale | Standard Deviation 5.38 |
| Placebo | 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) | 8.5 units on a scale | Standard Deviation 5.36 |
| Placebo | 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) | 8.7 units on a scale | Standard Deviation 5.76 |
| Placebo | 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) | 8.4 units on a scale | Standard Deviation 5.51 |
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loratadine | 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 |
| Loratadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 90 minutes | 2.3 units on a scale | Standard Deviation 1.1 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 360 minutes | 1.8 units on a scale | Standard Deviation 1.32 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 195 minutes | 1.7 units on a scale | Standard Deviation 1.22 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 15 minutes | 3.2 units on a scale | Standard Deviation 0.81 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 210 minutes | 1.7 units on a scale | Standard Deviation 1.28 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 225 minutes | 1.7 units on a scale | Standard Deviation 1.27 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 240 minutes | 1.7 units on a scale | Standard Deviation 1.24 |
| Fexofenadine | 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 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 255 minutes | 1.7 units on a scale | Standard Deviation 1.21 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 270 minutes | 1.7 units on a scale | Standard Deviation 1.25 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 45 minutes | 2.6 units on a scale | Standard Deviation 0.96 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 285 minutes | 1.8 units on a scale | Standard Deviation 1.22 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 105 minutes | 2.1 units on a scale | Standard Deviation 1.1 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 300 minutes | 1.8 units on a scale | Standard Deviation 1.2 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 60 minutes | 2.4 units on a scale | Standard Deviation 1.05 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 75 minutes | 2.3 units on a scale | Standard Deviation 1.14 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 150 minutes | 1.8 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 120 minutes | 1.8 units on a scale | Standard Deviation 1.12 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 165 minutes | 1.7 units on a scale | Standard Deviation 1.22 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 90 minutes | 2.1 units on a scale | Standard Deviation 1.07 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 180 minutes | 1.8 units on a scale | Standard Deviation 1.25 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 315 minutes | 1.8 units on a scale | Standard Deviation 1.22 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 135 minutes | 1.8 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 330 minutes | 1.7 units on a scale | Standard Deviation 1.25 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 345 minutes | 1.7 units on a scale | Standard Deviation 1.29 |
| Fexofenadine | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 0 minutes | 3.3 units on a scale | Standard Deviation 0.73 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 300 minutes | 2.1 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 135 minutes | 2.2 units on a scale | Standard Deviation 1.22 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 90 minutes | 2.4 units on a scale | Standard Deviation 1.17 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 105 minutes | 2.4 units on a scale | Standard Deviation 1.1 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 120 minutes | 2.1 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 15 minutes | 3.1 units on a scale | Standard Deviation 0.93 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 30 minutes | 2.8 units on a scale | Standard Deviation 0.99 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 45 minutes | 2.8 units on a scale | Standard Deviation 1.04 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 60 minutes | 2.6 units on a scale | Standard Deviation 1.07 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 75 minutes | 2.5 units on a scale | Standard Deviation 1.19 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 150 minutes | 2.2 units on a scale | Standard Deviation 1.18 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 165 minutes | 2.2 units on a scale | Standard Deviation 1.14 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 180 minutes | 2.2 units on a scale | Standard Deviation 1.12 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 315 minutes | 2.2 units on a scale | Standard Deviation 1.38 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 330 minutes | 2.1 units on a scale | Standard Deviation 1.31 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 345 minutes | 2.2 units on a scale | Standard Deviation 1.36 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 360 minutes | 2.2 units on a scale | Standard Deviation 1.38 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 195 minutes | 2.2 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 210 minutes | 2.2 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 225 minutes | 2.2 units on a scale | Standard Deviation 1.25 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 240 minutes | 2.2 units on a scale | Standard Deviation 1.24 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 255 minutes | 2.2 units on a scale | Standard Deviation 1.3 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 270 minutes | 2.1 units on a scale | Standard Deviation 1.31 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 285 minutes | 2.2 units on a scale | Standard Deviation 1.29 |
| Placebo | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | 0 minutes | 3.4 units on a scale | Standard Deviation 0.77 |
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 105 minutes | 2.4 units on a scale | Standard Deviation 1.1 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 180 minutes | 2.1 units on a scale | Standard Deviation 1.2 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 150 minutes | 2.3 units on a scale | Standard Deviation 1.1 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 270 minutes | 1.9 units on a scale | Standard Deviation 1.3 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 255 minutes | 2.0 units on a scale | Standard Deviation 1.3 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 240 minutes | 1.8 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 315 minutes | 1.8 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 345 minutes | 1.8 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 0 minutes | 3.2 units on a scale | Standard Deviation 0.78 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 15 minutes | 3.0 units on a scale | Standard Deviation 0.91 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 30 minutes | 2.9 units on a scale | Standard Deviation 0.99 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 45 minutes | 2.6 units on a scale | Standard Deviation 1.05 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 60 minutes | 2.3 units on a scale | Standard Deviation 1.02 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 75 minutes | 2.2 units on a scale | Standard Deviation 1.08 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 90 minutes | 2.1 units on a scale | Standard Deviation 1.08 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 105 minutes | 2.1 units on a scale | Standard Deviation 1.03 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 120 minutes | 2.0 units on a scale | Standard Deviation 1 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 135 minutes | 2.0 units on a scale | Standard Deviation 1.07 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 150 minutes | 2.0 units on a scale | Standard Deviation 1.07 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 165 minutes | 1.8 units on a scale | Standard Deviation 1.14 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 180 minutes | 1.9 units on a scale | Standard Deviation 1.2 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 195 minutes | 1.9 units on a scale | Standard Deviation 1.21 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 210 minutes | 1.8 units on a scale | Standard Deviation 1.22 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 225 minutes | 1.8 units on a scale | Standard Deviation 1.24 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 255 minutes | 1.7 units on a scale | Standard Deviation 1.15 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 270 minutes | 1.8 units on a scale | Standard Deviation 1.1 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 285 minutes | 1.9 units on a scale | Standard Deviation 1.15 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 300 minutes | 1.8 units on a scale | Standard Deviation 1.14 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 330 minutes | 1.8 units on a scale | Standard Deviation 1.18 |
| Fexofenadine | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 360 minutes | 1.9 units on a scale | Standard Deviation 1.23 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 300 minutes | 2.3 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 210 minutes | 2.3 units on a scale | Standard Deviation 1.24 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 75 minutes | 2.6 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 0 minutes | 3.3 units on a scale | Standard Deviation 0.89 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 225 minutes | 2.3 units on a scale | Standard Deviation 1.19 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 60 minutes | 2.7 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 270 minutes | 2.3 units on a scale | Standard Deviation 1.35 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 240 minutes | 2.2 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 45 minutes | 2.8 units on a scale | Standard Deviation 1.15 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 360 minutes | 2.3 units on a scale | Standard Deviation 1.33 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 255 minutes | 2.3 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 30 minutes | 2.9 units on a scale | Standard Deviation 1.14 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 330 minutes | 2.3 units on a scale | Standard Deviation 1.31 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 345 minutes | 2.4 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 150 minutes | 2.4 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 135 minutes | 2.4 units on a scale | Standard Deviation 1.19 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 285 minutes | 2.3 units on a scale | Standard Deviation 1.31 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 165 minutes | 2.3 units on a scale | Standard Deviation 1.18 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 120 minutes | 2.3 units on a scale | Standard Deviation 1.18 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 15 minutes | 3.0 units on a scale | Standard Deviation 1.09 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 180 minutes | 2.3 units on a scale | Standard Deviation 1.17 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 105 minutes | 2.5 units on a scale | Standard Deviation 1.16 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 315 minutes | 2.4 units on a scale | Standard Deviation 1.3 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 195 minutes | 2.4 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | 90 minutes | 2.4 units on a scale | Standard Deviation 1.28 |
Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 1.1 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 75 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.2 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 0 minutes (n=85, n=85, n=85) | 3.2 units on a scale | Standard Deviation 0.87 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 15 minutes (n=85, n=85, n=84) | 3.0 units on a scale | Standard Deviation 1.02 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 30 minutes (n=85, n=85, n=85) | 2.7 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 45 minutes (n=85, n=85, n=85) | 2.3 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | 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 1.18 |
| Fexofenadine | 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 1.13 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 150 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.2 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 60 minutes (n=85, n=85, n=85) | 2.1 units on a scale | Standard Deviation 1.14 |
| Fexofenadine | 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 1.17 |
| Fexofenadine | 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 1.15 |
| Fexofenadine | 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 1.14 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 165 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.24 |
| Fexofenadine | 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 1.18 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 195 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | 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 1.21 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 225 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 240 minutes (n=84, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.11 |
| Fexofenadine | 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 1.15 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 285 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | 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 1.18 |
| Fexofenadine | 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 1.24 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 330 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.24 |
| Fexofenadine | 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 1.27 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 360 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.25 |
| Placebo | 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 1.2 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 225 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 150 minutes (n=85, n=85, n=85) | 1.6 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 0 minutes (n=85, n=85, n=85) | 3.1 units on a scale | Standard Deviation 1.08 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 135 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 330 minutes (n=85, n=85, n=85) | 1.6 units on a scale | Standard Deviation 1.38 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 270 minutes (n=85, n=85, n=85) | 1.6 units on a scale | Standard Deviation 1.3 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 120 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.3 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 15 minutes (n=85, n=85, n=84) | 2.8 units on a scale | Standard Deviation 1.15 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 285 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.42 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 255 minutes (n=85, n=85, n=85) | 1.6 units on a scale | Standard Deviation 1.31 |
| Placebo | 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 1.29 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 360 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.37 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 90 minutes (n=85, n=85, n=85) | 1.9 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 300 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.33 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 165 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.28 |
| Placebo | 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 1.25 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 240 minutes (n=84, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.29 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 180 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.23 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 60 minutes (n=85, n=85, n=85) | 2.2 units on a scale | Standard Deviation 1.23 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 345 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.38 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 195 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.3 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 45 minutes (n=85, n=85, n=85) | 2.4 units on a scale | Standard Deviation 1.24 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 315 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.36 |
| Placebo | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | 210 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.26 |
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 1.2 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 1.2 |
| Loratadine | 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 1.2 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 1.2 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 225 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.2 |
| Fexofenadine | 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 1.05 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 15 minutes (n=85, n=85, n=85) | 3.0 units on a scale | Standard Deviation 1.06 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 30 minutes (n=85, n=85, n=85) | 2.8 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 45 minutes (n=85, n=85, n=85) | 2.8 units on a scale | Standard Deviation 1.09 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 60 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.27 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 75 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.16 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 90 minutes (n=85, n=85, n=85) | 2.3 units on a scale | Standard Deviation 1.16 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 105 minutes (n=85, n=85, n=85) | 2.4 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 120 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.15 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 135 minutes (n=85, n=85, n=85) | 2.3 units on a scale | Standard Deviation 1.24 |
| Fexofenadine | 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 1.17 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 165 minutes (n=85, n=85, n=85) | 2.2 units on a scale | Standard Deviation 1.21 |
| Fexofenadine | 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 1.21 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 195 minutes (n=85, n=85, n=85) | 2.1 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 210 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.12 |
| Fexofenadine | 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 1.15 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 255 minutes (n=85, n=85, n=84) | 2.0 units on a scale | Standard Deviation 1.22 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 270 minutes (n=85, n=85, n=85) | 1.6 units on a scale | Standard Deviation 1.16 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 285 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.26 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 300 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.21 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 315 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.23 |
| Fexofenadine | 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 1.22 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 345 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.25 |
| Fexofenadine | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 360 minutes (n=85, n=85, n=85) | 1.3 units on a scale | Standard Deviation 1.21 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 240 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.31 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 105 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.14 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 0 minutes (n=85, n=85, n=85) | 2.9 units on a scale | Standard Deviation 1.17 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 255 minutes (n=85, n=85, n=84) | 2.4 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 90 minutes (n=85, n=85, n=85) | 2.3 units on a scale | Standard Deviation 1.25 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 330 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.23 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 270 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.29 |
| Placebo | 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 1.12 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 15 minutes (n=85, n=85, n=85) | 3.0 units on a scale | Standard Deviation 1.09 |
| Placebo | 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 1.31 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 60 minutes (n=85, n=85, n=85) | 2.4 units on a scale | Standard Deviation 1.25 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 360 minutes (n=85, n=85, n=85) | 1.7 units on a scale | Standard Deviation 1.27 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 300 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 45 minutes (n=85, n=85, n=85) | 2.8 units on a scale | Standard Deviation 1.06 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 180 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.29 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 345 minutes (n=85, n=85, n=85) | 2.5 units on a scale | Standard Deviation 1.29 |
| Placebo | 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 1.26 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 165 minutes (n=85, n=85, n=85) | 2.4 units on a scale | Standard Deviation 1.29 |
| Placebo | 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 1.3 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 210 minutes (n=85, n=85, n=85) | 1.9 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 150 minutes (n=85, n=85, n=85) | 1.9 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 135 minutes (n=85, n=85, n=85) | 2.5 units on a scale | Standard Deviation 1.24 |
| Placebo | 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 1.25 |
| Placebo | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | 120 minutes (n=85, n=85, n=85) | 2.1 units on a scale | Standard Deviation 1.31 |
| Placebo | 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 1.27 |
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 1.2 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 75 minutes (n=85, n=85, n=85) | 2.1 units on a scale | Standard Deviation 1.21 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 0 minutes (n=85, n=85, n=85) | 3.2 units on a scale | Standard Deviation 0.88 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 15 minutes (n=85, n=85, n=85) | 2.2 units on a scale | Standard Deviation 1.25 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 30 minutes (n=85, n=85, n=85) | 1.5 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 45 minutes (n=85, n=85, n=85) | 2.1 units on a scale | Standard Deviation 1.21 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 60 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.2 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 90 minutes (n=85, n=85, n=85) | 1.3 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 105 minutes (n=85, n=85, n=85) | 2.1 units on a scale | Standard Deviation 1.2 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 240 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.21 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 255 minutes (n=85, n=85, n=84) | 2.0 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 270 minutes (n=85, n=85, n=84) | 1.3 units on a scale | Standard Deviation 1.22 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 285 minutes (n=85, n=85, n=85) | 2.1 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 300 minutes (n=85, n=85, n=85) | 1.3 units on a scale | Standard Deviation 1.25 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 315 minutes (n=85, n=85, n=85) | 2.1 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 330 minutes (n=85, n=85, n=85) | 1.3 units on a scale | Standard Deviation 1.24 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 345 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.24 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 360 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.31 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 120 minutes (n=85, n=85, n=85) | 1.4 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 135 minutes (n=85, n=85, n=85) | 2.1 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 150 minutes (n=85, n=85, n=85) | 1.3 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 165 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.14 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 180 minutes (n=85, n=85, n=85) | 1.3 units on a scale | Standard Deviation 1.22 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 195 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.15 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 210 minutes (n=85, n=85, n=85) | 1.3 units on a scale | Standard Deviation 1.2 |
| Fexofenadine | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 225 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.24 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 75 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.24 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 180 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.39 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 360 minutes (n=85, n=85, n=85) | 1.9 units on a scale | Standard Deviation 1.51 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 15 minutes (n=85, n=85, n=85) | 2.7 units on a scale | Standard Deviation 1.19 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 120 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.31 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 240 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 210 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.34 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 135 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.26 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 60 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.34 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 195 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.25 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 150 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.31 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 45 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.22 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 285 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.34 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 270 minutes (n=85, n=85, n=84) | 1.8 units on a scale | Standard Deviation 1.46 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 225 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 300 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.43 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 255 minutes (n=85, n=85, n=84) | 2.6 units on a scale | Standard Deviation 1.3 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 165 minutes (n=85, n=85, n=85) | 2.5 units on a scale | Standard Deviation 1.33 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 315 minutes (n=85, n=85, n=85) | 2.5 units on a scale | Standard Deviation 1.39 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 105 minutes (n=85, n=85, n=85) | 2.6 units on a scale | Standard Deviation 1.24 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 30 minutes (n=85, n=85, n=85) | 2.0 units on a scale | Standard Deviation 1.26 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 330 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.47 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 90 minutes (n=85, n=85, n=85) | 1.8 units on a scale | Standard Deviation 1.34 |
| Placebo | 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 0.76 |
| Placebo | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | 345 minutes (n=85, n=85, n=85) | 2.5 units on a scale | Standard Deviation 1.33 |
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 1.1 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 300 minutes (n=84, n=85, n=85) | 0.5 units on a scale | Standard Deviation 0.95 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 225 minutes (n=85, n=85, n=85) | 0.6 units on a scale | Standard Deviation 0.93 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 240 minutes (n=85, n=85, n=85) | 0.5 units on a scale | Standard Deviation 1.04 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 255 minutes (n=85, n=85, n=85) | 0.4 units on a scale | Standard Deviation 0.86 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 270 minutes (n=85, n=85, n=85) | 0.5 units on a scale | Standard Deviation 1 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 285 minutes (n=85, n=85, n=85) | 0.6 units on a scale | Standard Deviation 1.07 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 210 minutes (n=85, n=85, n=85) | 0.5 units on a scale | Standard Deviation 1.03 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 315 minutes (n=84, n=85, n=85) | 0.4 units on a scale | Standard Deviation 0.94 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 330 minutes (n=85, n=85, n=85) | 0.6 units on a scale | Standard Deviation 1.03 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 345 minutes (n=84, n=85, n=85) | 0.6 units on a scale | Standard Deviation 0.99 |
| Fexofenadine | 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 1.09 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 0 minutes (n=85, n=85, n=85) | 1.2 units on a scale | Standard Deviation 1.36 |
| Fexofenadine | 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 1.39 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 30 minutes (n=85, n=85, n=85) | 1.1 units on a scale | Standard Deviation 1.32 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 45 minutes (n=85, n=85, n=85) | 0.9 units on a scale | Standard Deviation 1.22 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 60 minutes (n=85, n=85, n=85) | 0.7 units on a scale | Standard Deviation 1.12 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 75 minutes (n=85, n=85, n=85) | 0.8 units on a scale | Standard Deviation 1.16 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 90 minutes (n=85, n=85, n=85) | 0.6 units on a scale | Standard Deviation 1.07 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 105 minutes (n=85, n=85, n=85) | 0.6 units on a scale | Standard Deviation 1.07 |
| Fexofenadine | 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 1.04 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 135 minutes (n=85, n=85, n=85) | 0.7 units on a scale | Standard Deviation 1.2 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 150 minutes (n=85, n=85, n=85) | 0.6 units on a scale | Standard Deviation 1.14 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 165 minutes (n=85, n=85, n=85) | 0.5 units on a scale | Standard Deviation 1.03 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 180 minutes (n=85, n=85, n=85) | 0.6 units on a scale | Standard Deviation 1.11 |
| Fexofenadine | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 195 minutes (n=85, n=85, n=85) | 0.6 units on a scale | Standard Deviation 1.09 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 330 minutes (n=85, n=85, n=85) | 1.0 units on a scale | Standard Deviation 1.38 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 165 minutes (n=85, n=85, n=85) | 0.9 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 90 minutes (n=85, n=85, n=85) | 1.0 units on a scale | Standard Deviation 1.37 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 315 minutes (n=84, n=85, n=85) | 1.1 units on a scale | Standard Deviation 1.4 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 240 minutes (n=85, n=85, n=85) | 0.9 units on a scale | Standard Deviation 1.29 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 105 minutes (n=85, n=85, n=85) | 1.1 units on a scale | Standard Deviation 1.43 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 300 minutes (n=84, n=85, n=85) | 0.9 units on a scale | Standard Deviation 1.34 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 195 minutes (n=85, n=85, n=85) | 1.0 units on a scale | Standard Deviation 1.38 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 120 minutes (n=85, n=85, n=85) | 0.9 units on a scale | Standard Deviation 1.28 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 285 minutes (n=85, n=85, n=85) | 1.1 units on a scale | Standard Deviation 1.42 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 180 minutes (n=85, n=85, n=85) | 0.9 units on a scale | Standard Deviation 1.3 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 135 minutes (n=85, n=85, n=85) | 1.2 units on a scale | Standard Deviation 1.48 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 270 minutes (n=85, n=85, n=85) | 1.0 units on a scale | Standard Deviation 1.4 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 15 minutes (n=85, n=85, n=85) | 1.3 units on a scale | Standard Deviation 1.37 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 225 minutes (n=85, n=85, n=85) | 0.9 units on a scale | Standard Deviation 1.33 |
| Placebo | 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 1.38 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 0 minutes (n=85, n=85, n=85) | 1.5 units on a scale | Standard Deviation 1.4 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 150 minutes (n=85, n=85, n=85) | 1.1 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 45 minutes (n=85, n=85, n=85) | 1.3 units on a scale | Standard Deviation 1.39 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 360 minutes (n=85, n=85, n=85) | 1.0 units on a scale | Standard Deviation 1.38 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 255 minutes (n=85, n=85, n=85) | 1.0 units on a scale | Standard Deviation 1.41 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 60 minutes (n=85, n=85, n=85) | 1.2 units on a scale | Standard Deviation 1.36 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 345 minutes (n=84, n=85, n=85) | 1.0 units on a scale | Standard Deviation 1.33 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 210 minutes (n=85, n=85, n=85) | 1.0 units on a scale | Standard Deviation 1.31 |
| Placebo | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | 75 minutes (n=85, n=85, n=85) | 1.1 units on a scale | Standard Deviation 1.39 |
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation 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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Loratadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 360 minutes | 1.2 units on a scale | Standard Deviation 1.2 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Loratadine | 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 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 240 minutes | 1.1 units on a scale | Standard Deviation 1.1 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 60 minutes | 1.9 units on a scale | Standard Deviation 1.16 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 120 minutes | 1.3 units on a scale | Standard Deviation 1.09 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 135 minutes | 1.3 units on a scale | Standard Deviation 1.11 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 150 minutes | 1.2 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | 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 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 180 minutes | 1.1 units on a scale | Standard Deviation 1.12 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 195 minutes | 1.2 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 225 minutes | 1.1 units on a scale | Standard Deviation 1.16 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 285 minutes | 1.2 units on a scale | Standard Deviation 1.13 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 330 minutes | 1.2 units on a scale | Standard Deviation 1.15 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 345 minutes | 1.2 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 0 minutes | 2.8 units on a scale | Standard Deviation 1.05 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 15 minutes | 2.6 units on a scale | Standard Deviation 1.1 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 30 minutes | 2.3 units on a scale | Standard Deviation 1.17 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 45 minutes | 2.0 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 75 minutes | 1.8 units on a scale | Standard Deviation 1.19 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 90 minutes | 1.6 units on a scale | Standard Deviation 1.23 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 105 minutes | 1.6 units on a scale | Standard Deviation 1.13 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 210 minutes | 1.1 units on a scale | Standard Deviation 1.13 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 255 minutes | 1.1 units on a scale | Standard Deviation 1.13 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 270 minutes | 1.1 units on a scale | Standard Deviation 1.09 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 300 minutes | 1.1 units on a scale | Standard Deviation 1.1 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 315 minutes | 1.2 units on a scale | Standard Deviation 1.13 |
| Fexofenadine | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 360 minutes | 1.3 units on a scale | Standard Deviation 1.17 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 345 minutes | 1.4 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 225 minutes | 1.4 units on a scale | Standard Deviation 1.25 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 360 minutes | 1.4 units on a scale | Standard Deviation 1.34 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 210 minutes | 1.4 units on a scale | Standard Deviation 1.27 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 195 minutes | 1.5 units on a scale | Standard Deviation 1.21 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 180 minutes | 1.3 units on a scale | Standard Deviation 1.16 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 165 minutes | 1.4 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 240 minutes | 1.4 units on a scale | Standard Deviation 1.24 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 315 minutes | 1.4 units on a scale | Standard Deviation 1.33 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 255 minutes | 1.4 units on a scale | Standard Deviation 1.26 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 150 minutes | 1.4 units on a scale | Standard Deviation 1.2 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 330 minutes | 1.4 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 270 minutes | 1.4 units on a scale | Standard Deviation 1.21 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 135 minutes | 1.4 units on a scale | Standard Deviation 1.29 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 285 minutes | 1.4 units on a scale | Standard Deviation 1.27 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 120 minutes | 1.4 units on a scale | Standard Deviation 1.18 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 45 minutes | 2.0 units on a scale | Standard Deviation 1.18 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 30 minutes | 2.1 units on a scale | Standard Deviation 1.25 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 60 minutes | 1.9 units on a scale | Standard Deviation 1.12 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 75 minutes | 1.6 units on a scale | Standard Deviation 1.11 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 15 minutes | 2.4 units on a scale | Standard Deviation 1.15 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 300 minutes | 1.3 units on a scale | Standard Deviation 1.32 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 90 minutes | 1.5 units on a scale | Standard Deviation 1.18 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 0 minutes | 2.7 units on a scale | Standard Deviation 1.02 |
| Placebo | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | 105 minutes | 1.5 units on a scale | Standard Deviation 1.19 |