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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT01469234
Collaborator
(none)
255
Enrollment
3
Arms
1
Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
255 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Oct 1, 2011
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: loratadine

Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.

Drug: loratadine
loratadine, one 10 mg tablet, orally
Other Names:
  • SCH 029851

    • Drug: placebo to fexofenadine
    one tablet, orally
    Experimental: fexofenadine

    Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.

    Drug: fexofenadine
    fexofenadine, one 180 mg tablet, orally

    Drug: placebo to loratadine
    one tablet, orally
    Placebo Comparator: placebo

    Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.

    Drug: placebo to loratadine
    one tablet, orally

    Drug: placebo to fexofenadine
    one tablet, orally

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point [From time of sensitization (time 0) to end of visit (~8 hours)]

      The individual symptom score for Runny Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.

    2. Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point [From time of sensitization (time 0) to end of visit (~8 hours)]

      The individual symptom score for Itchy Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.

    3. Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point [From time of sensitization (time 0) to end of visit (~8 hours)]

      The individual symptom score for Sneezing was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.

    4. Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point [From time of sensitization (time 0) to end of visit (~8 hours)]

      The individual symptom score for Water Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.

    5. Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point [From time of sensitization (time 0) to end of visit (~8 hours)]

      The individual symptom score for Itchy Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.

    6. Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point [From time of sensitization (time 0) to end of visit (~8 hours)]

      The individual symptom score for Nasal Congestion was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.

    7. Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point [From time of sensitization (time 0) to end of visit (~8 hours)]

      The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Bayer

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bayer
    ClinicalTrials.gov Identifier:
    NCT01469234
    Other Study ID Numbers:
    • 18126
    • PT11-37
    • P08712
    First Posted:
    Nov 10, 2011
    Last Update Posted:
    Mar 11, 2015
    Last Verified:
    Feb 1, 2015
    Additional relevant MeSH terms:
    Rhinitis
    Rhinitis, Allergic
    Rhinitis, Allergic, Seasonal
    Loratadine
    Fexofenadine
    Terfenadine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Period Title: Overall Study
    STARTED 85 85 85
    COMPLETED 85 85 85
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Loratadine Fexofenadine Placebo Total
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4. Total of all reporting groups
    Overall Participants 85 85 85 255
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    41.5
    (13.52)
    43.1
    (12.21)
    40.6
    (12.56)
    41.7
    (12.77)
    Sex: Female, Male (Count of Participants)
    Female
    51
    60%
    53
    62.4%
    53
    62.4%
    157
    61.6%
    Male
    34
    40%
    32
    37.6%
    32
    37.6%
    98
    38.4%

    Outcome Measures

    1. Primary Outcome
    Title Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Measure Participants 85 85 85
    180 minutes (n=85, n=85, n=85)
    7.4
    (4.51)
    6.7
    (4.86)
    8.5
    (5.07)
    195 minutes (n=85, n=85, n=85)
    7.5
    (4.84)
    6.7
    (4.87)
    8.9
    (5.31)
    210 minutes (n=85, n=85, n=85)
    7.3
    (4.73)
    6.5
    (4.87)
    8.7
    (5.28)
    225 minutes (n=85, n=85, n=85)
    7.4
    (4.63)
    6.5
    (4.70)
    8.5
    (5.36)
    240 minutes (n=84, n=85, n=85)
    7.4
    (4.76)
    6.5
    (4.43)
    8.3
    (5.38)
    255 minutes (n=85, n=85, n=85)
    7.1
    (4.78)
    6.3
    (4.47)
    8.4
    (5.51)
    270 minutes (n=85, n=85, n=85)
    7.0
    (4.67)
    6.4
    (4.50)
    8.4
    (5.56)
    285 minutes (n=85, n=85, n=85)
    7.3
    (4.52)
    6.9
    (4.76)
    8.7
    (5.76)
    300 minutes (n=84, n=85, n=85)
    7.1
    (4.54)
    6.5
    (4.65)
    8.4
    (5.58)
    2. Secondary Outcome
    Title Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Measure Participants 85 85 85
    0 minutes
    3.4
    (0.77)
    3.2
    (0.78)
    3.3
    (0.89)
    15 minutes
    3.1
    (0.85)
    3.0
    (0.91)
    3.0
    (1.09)
    30 minutes
    3.0
    (0.95)
    2.9
    (0.99)
    2.9
    (1.14)
    45 minutes
    2.8
    (0.99)
    2.6
    (1.05)
    2.8
    (1.15)
    60 minutes
    2.7
    (1.06)
    2.3
    (1.02)
    2.7
    (1.20)
    75 minutes
    2.6
    (1.06)
    2.2
    (1.08)
    2.6
    (1.20)
    90 minutes
    2.4
    (1.04)
    2.1
    (1.08)
    2.4
    (1.28)
    105 minutes
    2.4
    (1.10)
    2.1
    (1.03)
    2.5
    (1.16)
    120 minutes
    2.1
    (1.07)
    2.0
    (1.00)
    2.3
    (1.18)
    135 minutes
    2.2
    (1.12)
    2.0
    (1.07)
    2.4
    (1.19)
    150 minutes
    2.3
    (1.10)
    2.0
    (1.07)
    2.4
    (1.20)
    165 minutes
    2.2
    (1.07)
    1.8
    (1.14)
    2.3
    (1.18)
    180 minutes
    2.1
    (1.20)
    1.9
    (1.20)
    2.3
    (1.17)
    195 minutes
    2.1
    (1.27)
    1.9
    (1.21)
    2.4
    (1.20)
    210 minutes
    2.0
    (1.23)
    1.8
    (1.22)
    2.3
    (1.24)
    225 minutes
    2.1
    (1.22)
    1.8
    (1.24)
    2.3
    (1.19)
    240 minutes
    2.0
    (1.23)
    1.8
    (1.19)
    2.2
    (1.20)
    255 minutes
    2.0
    (1.30)
    1.7
    (1.15)
    2.3
    (1.28)
    270 minutes
    1.9
    (1.30)
    1.8
    (1.10)
    2.3
    (1.35)
    285 minutes
    2.1
    (1.24)
    1.9
    (1.15)
    2.3
    (1.31)
    300 minutes
    2.0
    (1.26)
    1.8
    (1.14)
    2.3
    (1.28)
    315 minutes
    2.1
    (1.25)
    1.8
    (1.17)
    2.4
    (1.30)
    330 minutes
    2.2
    (1.26)
    1.8
    (1.18)
    2.3
    (1.31)
    345 minutes
    2.1
    (1.27)
    1.8
    (1.17)
    2.4
    (1.32)
    360 minutes
    2.1
    (1.29)
    1.9
    (1.23)
    2.3
    (1.33)
    3. Secondary Outcome
    Title Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Measure Participants 85 85 85
    0 minutes
    3.3
    (0.74)
    3.3
    (0.73)
    3.4
    (0.77)
    15 minutes
    3.1
    (0.84)
    3.2
    (0.81)
    3.1
    (0.93)
    30 minutes
    2.8
    (0.97)
    2.8
    (0.97)
    2.8
    (0.99)
    45 minutes
    2.7
    (1.02)
    2.6
    (0.96)
    2.8
    (1.04)
    60 minutes
    2.6
    (1.09)
    2.4
    (1.05)
    2.6
    (1.07)
    75 minutes
    2.4
    (1.16)
    2.3
    (1.14)
    2.5
    (1.19)
    90 minutes
    2.3
    (1.10)
    2.1
    (1.07)
    2.4
    (1.17)
    105 minutes
    2.2
    (1.08)
    2.1
    (1.10)
    2.4
    (1.10)
    120 minutes
    1.9
    (1.14)
    1.8
    (1.12)
    2.1
    (1.20)
    135 minutes
    2.0
    (1.12)
    1.8
    (1.17)
    2.2
    (1.22)
    150 minutes
    2.1
    (1.06)
    1.8
    (1.19)
    2.2
    (1.18)
    165 minutes
    2.0
    (1.09)
    1.7
    (1.22)
    2.2
    (1.14)
    180 minutes
    2.0
    (1.16)
    1.8
    (1.25)
    2.2
    (1.12)
    195 minutes
    1.9
    (1.23)
    1.7
    (1.22)
    2.2
    (1.20)
    210 minutes
    2.0
    (1.25)
    1.7
    (1.28)
    2.2
    (1.20)
    225 minutes
    1.9
    (1.18)
    1.7
    (1.27)
    2.2
    (1.25)
    240 minutes
    1.9
    (1.14)
    1.7
    (1.24)
    2.2
    (1.24)
    255 minutes
    1.8
    (1.24)
    1.7
    (1.21)
    2.2
    (1.30)
    270 minutes
    1.9
    (1.18)
    1.7
    (1.25)
    2.1
    (1.31)
    285 minutes
    1.9
    (1.17)
    1.8
    (1.22)
    2.2
    (1.29)
    300 minutes
    1.8
    (1.19)
    1.8
    (1.20)
    2.1
    (1.32)
    315 minutes
    1.8
    (1.26)
    1.8
    (1.22)
    2.2
    (1.38)
    330 minutes
    1.8
    (1.16)
    1.7
    (1.25)
    2.1
    (1.31)
    345 minutes
    1.9
    (1.23)
    1.7
    (1.29)
    2.2
    (1.36)
    360 minutes
    1.8
    (1.22)
    1.8
    (1.32)
    2.2
    (1.38)
    4. Secondary Outcome
    Title Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Measure Participants 85 85 85
    0 minutes (n=85, n=85, n=85)
    1.3
    (1.37)
    1.2
    (1.36)
    1.5
    (1.40)
    15 minutes (n=85, n=85, n=85)
    1.2
    (1.31)
    1.2
    (1.39)
    1.3
    (1.37)
    30 minutes (n=85, n=85, n=85)
    1.2
    (1.34)
    1.1
    (1.32)
    1.2
    (1.38)
    45 minutes (n=85, n=85, n=85)
    1.0
    (1.29)
    0.9
    (1.22)
    1.3
    (1.39)
    60 minutes (n=85, n=85, n=85)
    1.1
    (1.21)
    0.7
    (1.12)
    1.2
    (1.36)
    75 minutes (n=85, n=85, n=85)
    1.0
    (1.25)
    0.8
    (1.16)
    1.1
    (1.39)
    90 minutes (n=85, n=85, n=85)
    0.7
    (1.12)
    0.6
    (1.07)
    1.0
    (1.37)
    105 minutes (n=85, n=85, n=85)
    0.8
    (1.16)
    0.6
    (1.07)
    1.1
    (1.43)
    120 minutes (n=85, n=85, n=85)
    0.5
    (0.88)
    0.5
    (1.04)
    0.9
    (1.28)
    135 minutes (n=85, n=85, n=85)
    0.8
    (1.13)
    0.7
    (1.20)
    1.2
    (1.48)
    150 minutes (n=85, n=85, n=85)
    0.9
    (1.22)
    0.6
    (1.14)
    1.1
    (1.32)
    165 minutes (n=85, n=85, n=85)
    0.8
    (1.11)
    0.5
    (1.03)
    0.9
    (1.32)
    180 minutes (n=85, n=85, n=85)
    0.7
    (1.08)
    0.6
    (1.11)
    0.9
    (1.30)
    195 minutes (n=85, n=85, n=85)
    0.8
    (1.19)
    0.6
    (1.09)
    1.0
    (1.38)
    210 minutes (n=85, n=85, n=85)
    0.7
    (1.07)
    0.5
    (1.03)
    1.0
    (1.31)
    225 minutes (n=85, n=85, n=85)
    0.7
    (1.04)
    0.6
    (0.93)
    0.9
    (1.33)
    240 minutes (n=85, n=85, n=85)
    0.7
    (1.09)
    0.5
    (1.04)
    0.9
    (1.29)
    255 minutes (n=85, n=85, n=85)
    0.6
    (1.15)
    0.4
    (0.86)
    1.0
    (1.41)
    270 minutes (n=85, n=85, n=85)
    0.6
    (1.13)
    0.5
    (1.00)
    1.0
    (1.40)
    285 minutes (n=85, n=85, n=85)
    0.8
    (1.08)
    0.6
    (1.07)
    1.1
    (1.42)
    300 minutes (n=84, n=85, n=85)
    0.7
    (1.02)
    0.5
    (0.95)
    0.9
    (1.34)
    315 minutes (n=84, n=85, n=85)
    0.7
    (1.10)
    0.4
    (0.94)
    1.1
    (1.40)
    330 minutes (n=85, n=85, n=85)
    0.7
    (1.02)
    0.6
    (1.03)
    1.0
    (1.38)
    345 minutes (n=84, n=85, n=85)
    0.7
    (1.09)
    0.6
    (0.99)
    1.0
    (1.33)
    360 minutes (n=85, n=85, n=85)
    0.6
    (1.12)
    0.6
    (1.09)
    1.0
    (1.38)
    5. Secondary Outcome
    Title Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Measure Participants 85 85 85
    0 minutes
    2.7
    (1.12)
    2.8
    (1.05)
    2.7
    (1.02)
    15 minutes
    2.4
    (1.17)
    2.6
    (1.10)
    2.4
    (1.15)
    30 minutes
    2.2
    (1.23)
    2.3
    (1.17)
    2.1
    (1.25)
    45 minutes
    1.9
    (1.22)
    2.0
    (1.19)
    2.0
    (1.18)
    60 minutes
    1.8
    (1.21)
    1.9
    (1.16)
    1.9
    (1.12)
    75 minutes
    1.7
    (1.21)
    1.8
    (1.19)
    1.6
    (1.11)
    90 minutes
    1.5
    (1.29)
    1.6
    (1.23)
    1.5
    (1.18)
    105 minutes
    1.5
    (1.22)
    1.6
    (1.13)
    1.5
    (1.19)
    120 minutes
    1.3
    (1.15)
    1.3
    (1.09)
    1.4
    (1.18)
    135 minutes
    1.2
    (1.11)
    1.3
    (1.11)
    1.4
    (1.29)
    150 minutes
    1.2
    (1.12)
    1.2
    (1.19)
    1.4
    (1.20)
    165 minutes
    1.2
    (1.14)
    1.2
    (1.14)
    1.4
    (1.20)
    180 minutes
    1.2
    (1.07)
    1.1
    (1.12)
    1.3
    (1.16)
    195 minutes
    1.2
    (1.15)
    1.2
    (1.19)
    1.5
    (1.21)
    210 minutes
    1.2
    (1.14)
    1.1
    (1.13)
    1.4
    (1.27)
    225 minutes
    1.2
    (1.13)
    1.1
    (1.16)
    1.4
    (1.25)
    240 minutes
    1.2
    (1.16)
    1.1
    (1.10)
    1.4
    (1.24)
    255 minutes
    1.2
    (1.12)
    1.1
    (1.13)
    1.4
    (1.26)
    270 minutes
    1.2
    (1.13)
    1.1
    (1.09)
    1.4
    (1.21)
    285 minutes
    1.2
    (1.08)
    1.2
    (1.13)
    1.4
    (1.27)
    300 minutes
    1.2
    (1.02)
    1.1
    (1.10)
    1.3
    (1.32)
    315 minutes
    1.2
    (1.09)
    1.2
    (1.13)
    1.4
    (1.33)
    330 minutes
    1.3
    (1.14)
    1.2
    (1.15)
    1.4
    (1.32)
    345 minutes
    1.2
    (1.15)
    1.2
    (1.19)
    1.4
    (1.32)
    360 minutes
    1.2
    (1.20)
    1.3
    (1.17)
    1.4
    (1.34)
    6. Secondary Outcome
    Title Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Measure Participants 85 85 85
    0 minutes (n=85, n=85, n=85)
    3.0
    (0.93)
    3.2
    (0.87)
    3.1
    (1.08)
    15 minutes (n=85, n=85, n=84)
    2.6
    (1.10)
    3.0
    (1.02)
    2.8
    (1.15)
    30 minutes (n=85, n=85, n=85)
    2.4
    (1.12)
    2.7
    (1.17)
    2.4
    (1.20)
    45 minutes (n=85, n=85, n=85)
    2.2
    (1.14)
    2.3
    (1.17)
    2.4
    (1.24)
    60 minutes (n=85, n=85, n=85)
    1.9
    (1.14)
    2.1
    (1.14)
    2.2
    (1.23)
    75 minutes (n=85, n=85, n=85)
    1.9
    (1.14)
    2.0
    (1.20)
    1.9
    (1.25)
    90 minutes (n=85, n=85, n=85)
    1.8
    (1.21)
    1.8
    (1.17)
    1.9
    (1.28)
    105 minutes (n=85, n=85, n=85)
    1.8
    (1.18)
    1.8
    (1.15)
    1.8
    (1.29)
    120 minutes (n=85, n=85, n=85)
    1.6
    (1.19)
    1.6
    (1.14)
    1.7
    (1.30)
    135 minutes (n=85, n=85, n=85)
    1.5
    (1.14)
    1.5
    (1.13)
    1.7
    (1.28)
    150 minutes (n=85, n=85, n=85)
    1.5
    (1.06)
    1.4
    (1.20)
    1.6
    (1.32)
    165 minutes (n=85, n=85, n=85)
    1.5
    (1.11)
    1.4
    (1.24)
    1.7
    (1.28)
    180 minutes (n=85, n=85, n=85)
    1.4
    (1.11)
    1.4
    (1.18)
    1.7
    (1.23)
    195 minutes (n=85, n=85, n=85)
    1.5
    (1.15)
    1.4
    (1.19)
    1.8
    (1.30)
    210 minutes (n=85, n=85, n=85)
    1.4
    (1.12)
    1.4
    (1.21)
    1.7
    (1.26)
    225 minutes (n=85, n=85, n=85)
    1.5
    (1.15)
    1.4
    (1.19)
    1.7
    (1.28)
    240 minutes (n=84, n=85, n=85)
    1.6
    (1.19)
    1.4
    (1.11)
    1.7
    (1.29)
    255 minutes (n=85, n=85, n=85)
    1.4
    (1.13)
    1.4
    (1.18)
    1.6
    (1.31)
    270 minutes (n=85, n=85, n=85)
    1.4
    (1.09)
    1.4
    (1.15)
    1.6
    (1.30)
    285 minutes (n=85, n=85, n=85)
    1.3
    (1.16)
    1.4
    (1.17)
    1.7
    (1.42)
    300 minutes (n=85, n=85, n=85)
    1.4
    (1.19)
    1.4
    (1.18)
    1.7
    (1.33)
    315 minutes (n=85, n=85, n=85)
    1.4
    (1.19)
    1.4
    (1.24)
    1.7
    (1.36)
    330 minutes (n=85, n=85, n=85)
    1.5
    (1.21)
    1.4
    (1.24)
    1.6
    (1.38)
    345 minutes (n=85, n=85, n=85)
    1.4
    (1.23)
    1.4
    (1.27)
    1.8
    (1.38)
    360 minutes (n=85, n=85, n=85)
    1.5
    (1.34)
    1.4
    (1.25)
    1.7
    (1.37)
    7. Secondary Outcome
    Title Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Measure Participants 85 85 85
    0 minutes (n=85, n=85, n=85)
    3.4
    (0.81)
    3.2
    (0.88)
    3.4
    (0.76)
    15 minutes (n=85, n=85, n=85)
    2.5
    (1.20)
    2.2
    (1.25)
    2.7
    (1.19)
    30 minutes (n=85, n=85, n=85)
    1.6
    (1.33)
    1.5
    (1.19)
    2.0
    (1.26)
    45 minutes (n=85, n=85, n=85)
    2.5
    (1.16)
    2.1
    (1.21)
    2.6
    (1.22)
    60 minutes (n=85, n=85, n=85)
    1.6
    (1.29)
    1.4
    (1.20)
    1.8
    (1.34)
    75 minutes (n=85, n=85, n=85)
    2.4
    (1.25)
    2.1
    (1.21)
    2.6
    (1.24)
    90 minutes (n=85, n=85, n=85)
    1.6
    (1.27)
    1.3
    (1.19)
    1.8
    (1.34)
    105 minutes (n=85, n=85, n=85)
    2.4
    (1.24)
    2.1
    (1.20)
    2.6
    (1.24)
    120 minutes (n=85, n=85, n=85)
    1.5
    (1.26)
    1.4
    (1.17)
    1.8
    (1.31)
    135 minutes (n=85, n=85, n=85)
    2.4
    (1.24)
    2.1
    (1.19)
    2.6
    (1.26)
    150 minutes (n=85, n=85, n=85)
    1.5
    (1.31)
    1.3
    (1.19)
    1.8
    (1.31)
    165 minutes (n=85, n=85, n=85)
    2.4
    (1.26)
    2.0
    (1.14)
    2.5
    (1.33)
    180 minutes (n=85, n=85, n=85)
    1.4
    (1.22)
    1.3
    (1.22)
    1.8
    (1.39)
    195 minutes (n=85, n=85, n=85)
    2.5
    (1.21)
    2.0
    (1.15)
    2.6
    (1.25)
    210 minutes (n=85, n=85, n=85)
    1.5
    (1.31)
    1.3
    (1.20)
    1.8
    (1.34)
    225 minutes (n=85, n=85, n=85)
    2.4
    (1.21)
    2.0
    (1.24)
    2.6
    (1.28)
    240 minutes (n=85, n=85, n=85)
    1.5
    (1.29)
    1.4
    (1.21)
    1.8
    (1.32)
    255 minutes (n=85, n=85, n=84)
    2.4
    (1.26)
    2.0
    (1.19)
    2.6
    (1.30)
    270 minutes (n=85, n=85, n=84)
    1.6
    (1.29)
    1.3
    (1.22)
    1.8
    (1.46)
    285 minutes (n=85, n=85, n=85)
    2.4
    (1.31)
    2.1
    (1.19)
    2.6
    (1.34)
    300 minutes (n=85, n=85, n=85)
    1.5
    (1.31)
    1.3
    (1.25)
    1.8
    (1.43)
    315 minutes (n=85, n=85, n=85)
    2.4
    (1.29)
    2.1
    (1.19)
    2.5
    (1.39)
    330 minutes (n=85, n=85, n=85)
    1.5
    (1.31)
    1.3
    (1.24)
    1.8
    (1.47)
    345 minutes (n=85, n=85, n=85)
    2.4
    (1.28)
    2.0
    (1.24)
    2.5
    (1.33)
    360 minutes (n=85, n=85, n=85)
    1.5
    (1.31)
    1.4
    (1.31)
    1.9
    (1.51)
    8. Secondary Outcome
    Title Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
    Description 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)

    Outcome Measure Data

    Analysis Population Description
    Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available. N=Number of Participants Analyzed, n=number of participants with data available at the given time point.
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Measure Participants 85 85 85
    0 minutes (n=85, n=85, n=85)
    3.0
    (1.08)
    3.0
    (1.05)
    2.9
    (1.17)
    15 minutes (n=85, n=85, n=85)
    3.2
    (1.05)
    3.0
    (1.06)
    3.0
    (1.09)
    30 minutes (n=85, n=85, n=85)
    2.6
    (1.19)
    2.8
    (1.17)
    2.6
    (1.27)
    45 minutes (n=85, n=85, n=85)
    3.0
    (1.11)
    2.8
    (1.09)
    2.8
    (1.06)
    60 minutes (n=85, n=85, n=85)
    2.3
    (1.29)
    2.6
    (1.27)
    2.4
    (1.25)
    75 minutes (n=85, n=85, n=85)
    2.8
    (1.16)
    2.6
    (1.16)
    2.8
    (1.12)
    90 minutes (n=85, n=85, n=85)
    2.0
    (1.22)
    2.3
    (1.16)
    2.3
    (1.25)
    105 minutes (n=85, n=85, n=85)
    2.7
    (1.19)
    2.4
    (1.17)
    2.6
    (1.14)
    120 minutes (n=85, n=85, n=85)
    1.9
    (1.24)
    2.0
    (1.15)
    2.1
    (1.31)
    135 minutes (n=85, n=85, n=85)
    2.6
    (1.20)
    2.3
    (1.24)
    2.5
    (1.24)
    150 minutes (n=85, n=85, n=85)
    1.8
    (1.21)
    1.8
    (1.17)
    1.9
    (1.32)
    165 minutes (n=85, n=85, n=85)
    2.5
    (1.17)
    2.2
    (1.21)
    2.4
    (1.29)
    180 minutes (n=85, n=85, n=85)
    1.7
    (1.20)
    1.7
    (1.21)
    1.8
    (1.29)
    195 minutes (n=85, n=85, n=85)
    2.4
    (1.25)
    2.1
    (1.17)
    2.4
    (1.26)
    210 minutes (n=85, n=85, n=85)
    1.6
    (1.21)
    1.7
    (1.12)
    1.9
    (1.28)
    225 minutes (n=85, n=85, n=85)
    2.3
    (1.13)
    2.0
    (1.20)
    2.3
    (1.25)
    240 minutes (n=85, n=85, n=85)
    1.5
    (1.18)
    1.5
    (1.15)
    1.7
    (1.31)
    255 minutes (n=85, n=85, n=84)
    2.3
    (1.19)
    2.0
    (1.22)
    2.4
    (1.28)
    270 minutes (n=85, n=85, n=85)
    1.5
    (1.20)
    1.6
    (1.16)
    1.7
    (1.29)
    285 minutes (n=85, n=85, n=85)
    2.4
    (1.16)
    2.0
    (1.26)
    2.4
    (1.31)
    300 minutes (n=85, n=85, n=85)
    1.5
    (1.14)
    1.4
    (1.21)
    1.8
    (1.32)
    315 minutes (n=85, n=85, n=85)
    2.4
    (1.18)
    2.0
    (1.23)
    2.4
    (1.30)
    330 minutes (n=85, n=85, n=85)
    1.4
    (1.19)
    1.4
    (1.22)
    1.7
    (1.23)
    345 minutes (n=85, n=85, n=85)
    2.3
    (1.20)
    2.0
    (1.25)
    2.5
    (1.29)
    360 minutes (n=85, n=85, n=85)
    1.4
    (1.17)
    1.3
    (1.21)
    1.7
    (1.27)

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Loratadine Fexofenadine Placebo
    Arm/Group Description Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4. Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    All Cause Mortality
    Loratadine Fexofenadine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Loratadine Fexofenadine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/85 (0%) 0/85 (0%) 0/85 (0%)
    Other (Not Including Serious) Adverse Events
    Loratadine Fexofenadine Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/85 (0%) 0/85 (0%) 0/85 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Senior Vice President, Global Clinical Development
    Organization Merck Sharp & Dohme Corp.
    Phone
    Email ClinicalTrialsDisclosure@merck.com
    Responsible Party:
    Bayer
    ClinicalTrials.gov Identifier:
    NCT01469234
    Other Study ID Numbers:
    • 18126
    • PT11-37
    • P08712
    First Posted:
    Nov 10, 2011
    Last Update Posted:
    Mar 11, 2015
    Last Verified:
    Feb 1, 2015