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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01469234
First received: November 8, 2011
Last updated: February 28, 2014
Last verified: February 2014

November 8, 2011
February 28, 2014
October 2011
November 2011   (final data collection date for primary outcome measure)
Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]
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.
Participant Major Symptom Complex (MSC) Score [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]
MSC is calculated as the sum of scores for runny nose, itchy nose, sneezing, watery eyes, and itchy eyes. Each 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), for a total ranging from 0 - 25. Increasing scores are associated with increasing severity.
Complete list of historical versions of study NCT01469234 on ClinicalTrials.gov Archive Site
  • Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]

    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 [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]

    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.

Participant Individual Symptom Scores [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ] [ Designated as safety issue: No ]
Individual symptom scores are 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), for a total ranging from 0 - 25. Increasing scores are associated with increasing severity.
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rhinitis
  • Drug: loratadine
    loratadine, one 10 mg tablet, orally
    Other Name: SCH 029851
  • Drug: fexofenadine
    fexofenadine, one 180 mg tablet, orally
  • Drug: placebo to loratadine
    one tablet, orally
  • Drug: placebo to fexofenadine
    one tablet, orally
  • Experimental: loratadine
    Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
    Interventions:
    • Drug: loratadine
    • Drug: placebo to fexofenadine
  • Experimental: fexofenadine
    Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
    Interventions:
    • Drug: fexofenadine
    • Drug: placebo to loratadine
  • Placebo Comparator: placebo
    Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.
    Interventions:
    • Drug: placebo to loratadine
    • Drug: placebo to fexofenadine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
255
November 2011
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01469234
P08712, PT11-37
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP