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

Primary Purpose

Rhinitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
loratadine
fexofenadine
placebo to loratadine
placebo to fexofenadine
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    loratadine

    fexofenadine

    placebo

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    November 8, 2011
    Last Updated
    February 20, 2015
    Sponsor
    Bayer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01469234
    Brief Title
    A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    November 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Bayer

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    255 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    loratadine
    Arm Type
    Experimental
    Arm Description
    Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
    Arm Title
    fexofenadine
    Arm Type
    Experimental
    Arm Description
    Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Intervention Type
    Drug
    Intervention Name(s)
    loratadine
    Other Intervention Name(s)
    SCH 029851
    Intervention Description
    loratadine, one 10 mg tablet, orally
    Intervention Type
    Drug
    Intervention Name(s)
    fexofenadine
    Intervention Description
    fexofenadine, one 180 mg tablet, orally
    Intervention Type
    Drug
    Intervention Name(s)
    placebo to loratadine
    Intervention Description
    one tablet, orally
    Intervention Type
    Drug
    Intervention Name(s)
    placebo to fexofenadine
    Intervention Description
    one tablet, orally
    Primary Outcome Measure Information:
    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)
    Secondary Outcome Measure Information:
    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)
    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)
    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)
    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)
    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)
    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)
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Learn more about this trial

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

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