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A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)

A Double-Blind, Parallel, Randomized, Placebo Controlled Trial to Evaluate Onset of Action of Loratadine and Fexofenadine in Subjects With Seasonal Allergic Rhinitis in a Pollen Challenge Chamber

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01469234
Enrollment
255
Registered
2011-11-10
Start date
2011-10-31
Completion date
2011-11-30
Last updated
2015-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinitis

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

DRUGloratadine

loratadine, one 10 mg tablet, orally

DRUGfexofenadine

fexofenadine, one 180 mg tablet, orally

DRUGplacebo to loratadine

one tablet, orally

DRUGplacebo to fexofenadine

one tablet, orally

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
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

MeasureTime frameDescription
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time PointFrom 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 PointFrom 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 PointFrom 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 PointFrom 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 PointFrom 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 PointFrom 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 PointFrom 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

ArmCount
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
Total255

Baseline characteristics

CharacteristicLoratadineFexofenadinePlaceboTotal
Age, Continuous41.5 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 Participants53 Participants53 Participants157 Participants
Sex: Female, Male
Male
34 Participants32 Participants32 Participants98 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 850 / 850 / 85
serious
Total, serious adverse events
0 / 850 / 850 / 85

Outcome results

Primary

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.

ArmMeasureGroupValue (MEAN)Dispersion
LoratadineMean 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 scaleStandard Deviation 4.63
LoratadineMean 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 scaleStandard Deviation 4.54
LoratadineMean 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 scaleStandard Deviation 4.78
LoratadineMean 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 scaleStandard Deviation 4.76
LoratadineMean 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 scaleStandard Deviation 4.51
LoratadineMean 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 scaleStandard Deviation 4.52
LoratadineMean 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 scaleStandard Deviation 4.73
LoratadineMean 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 scaleStandard Deviation 4.84
LoratadineMean 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 scaleStandard Deviation 4.67
FexofenadineMean 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 scaleStandard Deviation 4.43
FexofenadineMean 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 scaleStandard Deviation 4.86
FexofenadineMean 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 scaleStandard Deviation 4.87
FexofenadineMean 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 scaleStandard Deviation 4.87
FexofenadineMean 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 scaleStandard Deviation 4.7
FexofenadineMean 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 scaleStandard Deviation 4.47
FexofenadineMean 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 scaleStandard Deviation 4.5
FexofenadineMean 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 scaleStandard Deviation 4.76
FexofenadineMean 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 scaleStandard Deviation 4.65
PlaceboMean 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 scaleStandard Deviation 5.28
PlaceboMean 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 scaleStandard Deviation 5.07
PlaceboMean 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 scaleStandard Deviation 5.56
PlaceboMean 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 scaleStandard Deviation 5.31
PlaceboMean 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 scaleStandard Deviation 5.58
PlaceboMean 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 scaleStandard Deviation 5.38
PlaceboMean 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 scaleStandard Deviation 5.36
PlaceboMean 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 scaleStandard Deviation 5.76
PlaceboMean 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 scaleStandard Deviation 5.51
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point255 minutes1.8 units on a scaleStandard Deviation 1.24
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point90 minutes2.3 units on a scaleStandard Deviation 1.1
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point75 minutes2.4 units on a scaleStandard Deviation 1.16
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point225 minutes1.9 units on a scaleStandard Deviation 1.18
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point120 minutes1.9 units on a scaleStandard Deviation 1.14
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point150 minutes2.1 units on a scaleStandard Deviation 1.06
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point105 minutes2.2 units on a scaleStandard Deviation 1.08
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point270 minutes1.9 units on a scaleStandard Deviation 1.18
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point165 minutes2.0 units on a scaleStandard Deviation 1.09
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point210 minutes2.0 units on a scaleStandard Deviation 1.25
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point30 minutes2.8 units on a scaleStandard Deviation 0.97
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point180 minutes2.0 units on a scaleStandard Deviation 1.16
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point285 minutes1.9 units on a scaleStandard Deviation 1.17
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point135 minutes2.0 units on a scaleStandard Deviation 1.12
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point315 minutes1.8 units on a scaleStandard Deviation 1.26
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point240 minutes1.9 units on a scaleStandard Deviation 1.14
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point195 minutes1.9 units on a scaleStandard Deviation 1.23
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point330 minutes1.8 units on a scaleStandard Deviation 1.16
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point300 minutes1.8 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point0 minutes3.3 units on a scaleStandard Deviation 0.74
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point345 minutes1.9 units on a scaleStandard Deviation 1.23
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point45 minutes2.7 units on a scaleStandard Deviation 1.02
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point60 minutes2.6 units on a scaleStandard Deviation 1.09
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point360 minutes1.8 units on a scaleStandard Deviation 1.22
LoratadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point15 minutes3.1 units on a scaleStandard Deviation 0.84
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point360 minutes1.8 units on a scaleStandard Deviation 1.32
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point195 minutes1.7 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point15 minutes3.2 units on a scaleStandard Deviation 0.81
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point210 minutes1.7 units on a scaleStandard Deviation 1.28
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point225 minutes1.7 units on a scaleStandard Deviation 1.27
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point240 minutes1.7 units on a scaleStandard Deviation 1.24
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point30 minutes2.8 units on a scaleStandard Deviation 0.97
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point255 minutes1.7 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point270 minutes1.7 units on a scaleStandard Deviation 1.25
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point45 minutes2.6 units on a scaleStandard Deviation 0.96
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point285 minutes1.8 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point105 minutes2.1 units on a scaleStandard Deviation 1.1
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point300 minutes1.8 units on a scaleStandard Deviation 1.2
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point60 minutes2.4 units on a scaleStandard Deviation 1.05
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point75 minutes2.3 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point150 minutes1.8 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point120 minutes1.8 units on a scaleStandard Deviation 1.12
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point165 minutes1.7 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point90 minutes2.1 units on a scaleStandard Deviation 1.07
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point180 minutes1.8 units on a scaleStandard Deviation 1.25
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point315 minutes1.8 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point135 minutes1.8 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point330 minutes1.7 units on a scaleStandard Deviation 1.25
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point345 minutes1.7 units on a scaleStandard Deviation 1.29
FexofenadineMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point0 minutes3.3 units on a scaleStandard Deviation 0.73
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point300 minutes2.1 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point135 minutes2.2 units on a scaleStandard Deviation 1.22
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point90 minutes2.4 units on a scaleStandard Deviation 1.17
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point105 minutes2.4 units on a scaleStandard Deviation 1.1
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point120 minutes2.1 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point15 minutes3.1 units on a scaleStandard Deviation 0.93
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point30 minutes2.8 units on a scaleStandard Deviation 0.99
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point45 minutes2.8 units on a scaleStandard Deviation 1.04
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point60 minutes2.6 units on a scaleStandard Deviation 1.07
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point75 minutes2.5 units on a scaleStandard Deviation 1.19
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point150 minutes2.2 units on a scaleStandard Deviation 1.18
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point165 minutes2.2 units on a scaleStandard Deviation 1.14
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point180 minutes2.2 units on a scaleStandard Deviation 1.12
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point315 minutes2.2 units on a scaleStandard Deviation 1.38
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point330 minutes2.1 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point345 minutes2.2 units on a scaleStandard Deviation 1.36
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point360 minutes2.2 units on a scaleStandard Deviation 1.38
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point195 minutes2.2 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point210 minutes2.2 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point225 minutes2.2 units on a scaleStandard Deviation 1.25
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point240 minutes2.2 units on a scaleStandard Deviation 1.24
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point255 minutes2.2 units on a scaleStandard Deviation 1.3
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point270 minutes2.1 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point285 minutes2.2 units on a scaleStandard Deviation 1.29
PlaceboMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point0 minutes3.4 units on a scaleStandard Deviation 0.77
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point90 minutes2.4 units on a scaleStandard Deviation 1.04
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point315 minutes2.1 units on a scaleStandard Deviation 1.25
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point210 minutes2.0 units on a scaleStandard Deviation 1.23
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point105 minutes2.4 units on a scaleStandard Deviation 1.1
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point15 minutes3.1 units on a scaleStandard Deviation 0.85
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point195 minutes2.1 units on a scaleStandard Deviation 1.27
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point120 minutes2.1 units on a scaleStandard Deviation 1.07
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point330 minutes2.2 units on a scaleStandard Deviation 1.26
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point180 minutes2.1 units on a scaleStandard Deviation 1.2
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point135 minutes2.2 units on a scaleStandard Deviation 1.12
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point300 minutes2.0 units on a scaleStandard Deviation 1.26
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point165 minutes2.2 units on a scaleStandard Deviation 1.07
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point150 minutes2.3 units on a scaleStandard Deviation 1.1
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point30 minutes3.0 units on a scaleStandard Deviation 0.95
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point345 minutes2.1 units on a scaleStandard Deviation 1.27
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point270 minutes1.9 units on a scaleStandard Deviation 1.3
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point45 minutes2.8 units on a scaleStandard Deviation 0.99
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point285 minutes2.1 units on a scaleStandard Deviation 1.24
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point255 minutes2.0 units on a scaleStandard Deviation 1.3
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point60 minutes2.7 units on a scaleStandard Deviation 1.06
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point0 minutes3.4 units on a scaleStandard Deviation 0.77
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point240 minutes2.0 units on a scaleStandard Deviation 1.23
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point75 minutes2.6 units on a scaleStandard Deviation 1.06
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point360 minutes2.1 units on a scaleStandard Deviation 1.29
LoratadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point225 minutes2.1 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point240 minutes1.8 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point315 minutes1.8 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point345 minutes1.8 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point0 minutes3.2 units on a scaleStandard Deviation 0.78
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point15 minutes3.0 units on a scaleStandard Deviation 0.91
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point30 minutes2.9 units on a scaleStandard Deviation 0.99
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point45 minutes2.6 units on a scaleStandard Deviation 1.05
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point60 minutes2.3 units on a scaleStandard Deviation 1.02
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point75 minutes2.2 units on a scaleStandard Deviation 1.08
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point90 minutes2.1 units on a scaleStandard Deviation 1.08
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point105 minutes2.1 units on a scaleStandard Deviation 1.03
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point120 minutes2.0 units on a scaleStandard Deviation 1
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point135 minutes2.0 units on a scaleStandard Deviation 1.07
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point150 minutes2.0 units on a scaleStandard Deviation 1.07
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point165 minutes1.8 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point180 minutes1.9 units on a scaleStandard Deviation 1.2
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point195 minutes1.9 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point210 minutes1.8 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point225 minutes1.8 units on a scaleStandard Deviation 1.24
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point255 minutes1.7 units on a scaleStandard Deviation 1.15
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point270 minutes1.8 units on a scaleStandard Deviation 1.1
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point285 minutes1.9 units on a scaleStandard Deviation 1.15
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point300 minutes1.8 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point330 minutes1.8 units on a scaleStandard Deviation 1.18
FexofenadineMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point360 minutes1.9 units on a scaleStandard Deviation 1.23
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point300 minutes2.3 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point210 minutes2.3 units on a scaleStandard Deviation 1.24
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point75 minutes2.6 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point0 minutes3.3 units on a scaleStandard Deviation 0.89
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point225 minutes2.3 units on a scaleStandard Deviation 1.19
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point60 minutes2.7 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point270 minutes2.3 units on a scaleStandard Deviation 1.35
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point240 minutes2.2 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point45 minutes2.8 units on a scaleStandard Deviation 1.15
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point360 minutes2.3 units on a scaleStandard Deviation 1.33
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point255 minutes2.3 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point30 minutes2.9 units on a scaleStandard Deviation 1.14
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point330 minutes2.3 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point345 minutes2.4 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point150 minutes2.4 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point135 minutes2.4 units on a scaleStandard Deviation 1.19
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point285 minutes2.3 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point165 minutes2.3 units on a scaleStandard Deviation 1.18
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point120 minutes2.3 units on a scaleStandard Deviation 1.18
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point15 minutes3.0 units on a scaleStandard Deviation 1.09
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point180 minutes2.3 units on a scaleStandard Deviation 1.17
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point105 minutes2.5 units on a scaleStandard Deviation 1.16
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point315 minutes2.4 units on a scaleStandard Deviation 1.3
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point195 minutes2.4 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point90 minutes2.4 units on a scaleStandard Deviation 1.28
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.21
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.15
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)1.9 units on a scaleStandard Deviation 1.14
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)3.0 units on a scaleStandard Deviation 0.93
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.11
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.21
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)2.2 units on a scaleStandard Deviation 1.14
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.11
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.18
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.34
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.15
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point315 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.13
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point345 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.23
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point300 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.16
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.14
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.12
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.09
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.06
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=84)2.6 units on a scaleStandard Deviation 1.1
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point240 minutes (n=84, n=85, n=85)1.6 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.12
LoratadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)1.9 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.2
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)3.2 units on a scaleStandard Deviation 0.87
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=84)3.0 units on a scaleStandard Deviation 1.02
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)2.7 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)2.3 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.18
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.13
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.2
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)2.1 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.15
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.24
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.18
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point240 minutes (n=84, n=85, n=85)1.4 units on a scaleStandard Deviation 1.11
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.15
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point300 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.18
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point315 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.24
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.24
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point345 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.27
FexofenadineMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.25
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)3.1 units on a scaleStandard Deviation 1.08
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.38
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.3
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.3
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=84)2.8 units on a scaleStandard Deviation 1.15
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.42
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.29
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.37
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)1.9 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point300 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.33
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)1.9 units on a scaleStandard Deviation 1.25
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point240 minutes (n=84, n=85, n=85)1.7 units on a scaleStandard Deviation 1.29
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.23
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)2.2 units on a scaleStandard Deviation 1.23
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point345 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.38
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.3
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.24
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point315 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.36
PlaceboMean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.26
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)3.0 units on a scaleStandard Deviation 1.11
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point240 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.18
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.2
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.17
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)3.0 units on a scaleStandard Deviation 1.08
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.21
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point315 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.18
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)2.3 units on a scaleStandard Deviation 1.13
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)2.5 units on a scaleStandard Deviation 1.17
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)2.3 units on a scaleStandard Deviation 1.29
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.21
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.2
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point345 minutes (n=85, n=85, n=85)2.3 units on a scaleStandard Deviation 1.2
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.25
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point300 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.14
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)2.8 units on a scaleStandard Deviation 1.16
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.16
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.22
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=85)3.2 units on a scaleStandard Deviation 1.05
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.2
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)2.7 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=84)2.3 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)1.9 units on a scaleStandard Deviation 1.24
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.2
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)3.0 units on a scaleStandard Deviation 1.05
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=85)3.0 units on a scaleStandard Deviation 1.06
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)2.8 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)2.8 units on a scaleStandard Deviation 1.09
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.27
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.16
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)2.3 units on a scaleStandard Deviation 1.16
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.15
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)2.3 units on a scaleStandard Deviation 1.24
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)2.2 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)2.1 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.12
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point240 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.15
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=84)2.0 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.16
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.26
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point300 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point315 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.23
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point345 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.25
FexofenadineMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.21
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point240 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.14
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)2.9 units on a scaleStandard Deviation 1.17
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=84)2.4 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)2.3 units on a scaleStandard Deviation 1.25
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.23
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.29
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)2.8 units on a scaleStandard Deviation 1.12
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=85)3.0 units on a scaleStandard Deviation 1.09
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.25
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.7 units on a scaleStandard Deviation 1.27
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point300 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)2.8 units on a scaleStandard Deviation 1.06
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.29
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point345 minutes (n=85, n=85, n=85)2.5 units on a scaleStandard Deviation 1.29
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.26
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.29
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point315 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.3
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.9 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.9 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)2.5 units on a scaleStandard Deviation 1.24
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)2.3 units on a scaleStandard Deviation 1.25
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)2.1 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.27
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.31
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.26
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point240 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.29
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.33
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=84)2.4 units on a scaleStandard Deviation 1.26
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.21
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point315 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.29
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=84)1.6 units on a scaleStandard Deviation 1.29
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.22
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point300 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.31
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.31
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)2.5 units on a scaleStandard Deviation 1.16
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.31
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.26
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.29
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=85)2.5 units on a scaleStandard Deviation 1.2
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.31
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.25
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.24
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.31
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)1.6 units on a scaleStandard Deviation 1.27
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)3.4 units on a scaleStandard Deviation 0.81
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point345 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.28
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)2.4 units on a scaleStandard Deviation 1.24
LoratadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)2.5 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)2.1 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)3.2 units on a scaleStandard Deviation 0.88
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=85)2.2 units on a scaleStandard Deviation 1.25
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)2.1 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.2
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)2.1 units on a scaleStandard Deviation 1.2
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point240 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.21
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=84)2.0 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=84)1.3 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)2.1 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point300 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.25
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point315 minutes (n=85, n=85, n=85)2.1 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.24
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point345 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.24
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.31
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)1.4 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)2.1 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.15
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.2
FexofenadineMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.24
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.24
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.39
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.9 units on a scaleStandard Deviation 1.51
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=85)2.7 units on a scaleStandard Deviation 1.19
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point240 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.34
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.26
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.34
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.25
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.22
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.34
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=84)1.8 units on a scaleStandard Deviation 1.46
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point300 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.43
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=84)2.6 units on a scaleStandard Deviation 1.3
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)2.5 units on a scaleStandard Deviation 1.33
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point315 minutes (n=85, n=85, n=85)2.5 units on a scaleStandard Deviation 1.39
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)2.6 units on a scaleStandard Deviation 1.24
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)2.0 units on a scaleStandard Deviation 1.26
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.47
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)1.8 units on a scaleStandard Deviation 1.34
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)3.4 units on a scaleStandard Deviation 0.76
PlaceboMean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point345 minutes (n=85, n=85, n=85)2.5 units on a scaleStandard Deviation 1.33
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)0.7 units on a scaleStandard Deviation 1.12
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point345 minutes (n=84, n=85, n=85)0.7 units on a scaleStandard Deviation 1.09
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)0.7 units on a scaleStandard Deviation 1.07
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)1.0 units on a scaleStandard Deviation 1.25
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.12
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)0.8 units on a scaleStandard Deviation 1.11
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)1.1 units on a scaleStandard Deviation 1.21
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.37
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.13
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)1.0 units on a scaleStandard Deviation 1.29
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=85)1.2 units on a scaleStandard Deviation 1.31
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)0.8 units on a scaleStandard Deviation 1.19
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)1.2 units on a scaleStandard Deviation 1.34
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)0.9 units on a scaleStandard Deviation 1.22
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)0.8 units on a scaleStandard Deviation 1.08
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point240 minutes (n=85, n=85, n=85)0.7 units on a scaleStandard Deviation 1.09
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)0.8 units on a scaleStandard Deviation 1.13
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point300 minutes (n=84, n=85, n=85)0.7 units on a scaleStandard Deviation 1.02
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)0.7 units on a scaleStandard Deviation 1.04
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)0.5 units on a scaleStandard Deviation 0.88
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point315 minutes (n=84, n=85, n=85)0.7 units on a scaleStandard Deviation 1.1
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)0.7 units on a scaleStandard Deviation 1.08
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)0.8 units on a scaleStandard Deviation 1.16
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)0.7 units on a scaleStandard Deviation 1.02
LoratadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.15
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point300 minutes (n=84, n=85, n=85)0.5 units on a scaleStandard Deviation 0.95
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 0.93
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point240 minutes (n=85, n=85, n=85)0.5 units on a scaleStandard Deviation 1.04
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=85)0.4 units on a scaleStandard Deviation 0.86
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=85)0.5 units on a scaleStandard Deviation 1
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.07
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)0.5 units on a scaleStandard Deviation 1.03
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point315 minutes (n=84, n=85, n=85)0.4 units on a scaleStandard Deviation 0.94
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.03
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point345 minutes (n=84, n=85, n=85)0.6 units on a scaleStandard Deviation 0.99
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.09
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)1.2 units on a scaleStandard Deviation 1.36
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=85)1.2 units on a scaleStandard Deviation 1.39
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)1.1 units on a scaleStandard Deviation 1.32
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)0.9 units on a scaleStandard Deviation 1.22
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)0.7 units on a scaleStandard Deviation 1.12
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)0.8 units on a scaleStandard Deviation 1.16
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.07
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.07
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)0.5 units on a scaleStandard Deviation 1.04
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)0.7 units on a scaleStandard Deviation 1.2
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)0.5 units on a scaleStandard Deviation 1.03
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.11
FexofenadineMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)0.6 units on a scaleStandard Deviation 1.09
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point330 minutes (n=85, n=85, n=85)1.0 units on a scaleStandard Deviation 1.38
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point165 minutes (n=85, n=85, n=85)0.9 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point90 minutes (n=85, n=85, n=85)1.0 units on a scaleStandard Deviation 1.37
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point315 minutes (n=84, n=85, n=85)1.1 units on a scaleStandard Deviation 1.4
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point240 minutes (n=85, n=85, n=85)0.9 units on a scaleStandard Deviation 1.29
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point105 minutes (n=85, n=85, n=85)1.1 units on a scaleStandard Deviation 1.43
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point300 minutes (n=84, n=85, n=85)0.9 units on a scaleStandard Deviation 1.34
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point195 minutes (n=85, n=85, n=85)1.0 units on a scaleStandard Deviation 1.38
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point120 minutes (n=85, n=85, n=85)0.9 units on a scaleStandard Deviation 1.28
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point285 minutes (n=85, n=85, n=85)1.1 units on a scaleStandard Deviation 1.42
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point180 minutes (n=85, n=85, n=85)0.9 units on a scaleStandard Deviation 1.3
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point135 minutes (n=85, n=85, n=85)1.2 units on a scaleStandard Deviation 1.48
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point270 minutes (n=85, n=85, n=85)1.0 units on a scaleStandard Deviation 1.4
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point15 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.37
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point225 minutes (n=85, n=85, n=85)0.9 units on a scaleStandard Deviation 1.33
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point30 minutes (n=85, n=85, n=85)1.2 units on a scaleStandard Deviation 1.38
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point0 minutes (n=85, n=85, n=85)1.5 units on a scaleStandard Deviation 1.4
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point150 minutes (n=85, n=85, n=85)1.1 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point45 minutes (n=85, n=85, n=85)1.3 units on a scaleStandard Deviation 1.39
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point360 minutes (n=85, n=85, n=85)1.0 units on a scaleStandard Deviation 1.38
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point255 minutes (n=85, n=85, n=85)1.0 units on a scaleStandard Deviation 1.41
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point60 minutes (n=85, n=85, n=85)1.2 units on a scaleStandard Deviation 1.36
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point345 minutes (n=84, n=85, n=85)1.0 units on a scaleStandard Deviation 1.33
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point210 minutes (n=85, n=85, n=85)1.0 units on a scaleStandard Deviation 1.31
PlaceboMean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point75 minutes (n=85, n=85, n=85)1.1 units on a scaleStandard Deviation 1.39
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point360 minutes1.2 units on a scaleStandard Deviation 1.2
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point330 minutes1.3 units on a scaleStandard Deviation 1.14
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point285 minutes1.2 units on a scaleStandard Deviation 1.08
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point345 minutes1.2 units on a scaleStandard Deviation 1.15
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point150 minutes1.2 units on a scaleStandard Deviation 1.12
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point255 minutes1.2 units on a scaleStandard Deviation 1.12
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point315 minutes1.2 units on a scaleStandard Deviation 1.09
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point105 minutes1.5 units on a scaleStandard Deviation 1.22
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point15 minutes2.4 units on a scaleStandard Deviation 1.17
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point270 minutes1.2 units on a scaleStandard Deviation 1.13
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point90 minutes1.5 units on a scaleStandard Deviation 1.29
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point30 minutes2.2 units on a scaleStandard Deviation 1.23
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point165 minutes1.2 units on a scaleStandard Deviation 1.14
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point75 minutes1.7 units on a scaleStandard Deviation 1.21
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point45 minutes1.9 units on a scaleStandard Deviation 1.22
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point120 minutes1.3 units on a scaleStandard Deviation 1.15
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point0 minutes2.7 units on a scaleStandard Deviation 1.12
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point180 minutes1.2 units on a scaleStandard Deviation 1.07
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point60 minutes1.8 units on a scaleStandard Deviation 1.21
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point240 minutes1.2 units on a scaleStandard Deviation 1.16
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point195 minutes1.2 units on a scaleStandard Deviation 1.15
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point300 minutes1.2 units on a scaleStandard Deviation 1.02
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point225 minutes1.2 units on a scaleStandard Deviation 1.13
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point135 minutes1.2 units on a scaleStandard Deviation 1.11
LoratadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point210 minutes1.2 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point240 minutes1.1 units on a scaleStandard Deviation 1.1
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point60 minutes1.9 units on a scaleStandard Deviation 1.16
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point120 minutes1.3 units on a scaleStandard Deviation 1.09
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point135 minutes1.3 units on a scaleStandard Deviation 1.11
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point150 minutes1.2 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point165 minutes1.2 units on a scaleStandard Deviation 1.14
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point180 minutes1.1 units on a scaleStandard Deviation 1.12
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point195 minutes1.2 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point225 minutes1.1 units on a scaleStandard Deviation 1.16
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point285 minutes1.2 units on a scaleStandard Deviation 1.13
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point330 minutes1.2 units on a scaleStandard Deviation 1.15
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point345 minutes1.2 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point0 minutes2.8 units on a scaleStandard Deviation 1.05
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point15 minutes2.6 units on a scaleStandard Deviation 1.1
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point30 minutes2.3 units on a scaleStandard Deviation 1.17
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point45 minutes2.0 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point75 minutes1.8 units on a scaleStandard Deviation 1.19
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point90 minutes1.6 units on a scaleStandard Deviation 1.23
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point105 minutes1.6 units on a scaleStandard Deviation 1.13
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point210 minutes1.1 units on a scaleStandard Deviation 1.13
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point255 minutes1.1 units on a scaleStandard Deviation 1.13
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point270 minutes1.1 units on a scaleStandard Deviation 1.09
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point300 minutes1.1 units on a scaleStandard Deviation 1.1
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point315 minutes1.2 units on a scaleStandard Deviation 1.13
FexofenadineMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point360 minutes1.3 units on a scaleStandard Deviation 1.17
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point345 minutes1.4 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point225 minutes1.4 units on a scaleStandard Deviation 1.25
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point360 minutes1.4 units on a scaleStandard Deviation 1.34
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point210 minutes1.4 units on a scaleStandard Deviation 1.27
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point195 minutes1.5 units on a scaleStandard Deviation 1.21
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point180 minutes1.3 units on a scaleStandard Deviation 1.16
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point165 minutes1.4 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point240 minutes1.4 units on a scaleStandard Deviation 1.24
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point315 minutes1.4 units on a scaleStandard Deviation 1.33
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point255 minutes1.4 units on a scaleStandard Deviation 1.26
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point150 minutes1.4 units on a scaleStandard Deviation 1.2
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point330 minutes1.4 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point270 minutes1.4 units on a scaleStandard Deviation 1.21
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point135 minutes1.4 units on a scaleStandard Deviation 1.29
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point285 minutes1.4 units on a scaleStandard Deviation 1.27
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point120 minutes1.4 units on a scaleStandard Deviation 1.18
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point45 minutes2.0 units on a scaleStandard Deviation 1.18
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point30 minutes2.1 units on a scaleStandard Deviation 1.25
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point60 minutes1.9 units on a scaleStandard Deviation 1.12
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point75 minutes1.6 units on a scaleStandard Deviation 1.11
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point15 minutes2.4 units on a scaleStandard Deviation 1.15
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point300 minutes1.3 units on a scaleStandard Deviation 1.32
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point90 minutes1.5 units on a scaleStandard Deviation 1.18
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point0 minutes2.7 units on a scaleStandard Deviation 1.02
PlaceboMean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point105 minutes1.5 units on a scaleStandard Deviation 1.19

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026