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

Phase 4

Completed

• Conditions: Rhinitis
• Interventions: Drug: fexofenadine; Drug: loratadine; Drug: placebo to fexofenadine; Drug: placebo to loratadine

• Registration Number: NCT01469234
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Study First Submitted: 2011-11-08
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-10
• Results First Submitted: 2013-02-12
• Results First Submitted QC: 2013-02-12
• Results First Posted: 2013-03-22
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-20
• Last Update Posted: 2015-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 255

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
loratadine	placebo to fexofenadine	Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
fexofenadine	placebo to loratadine	Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
placebo	placebo to fexofenadine	Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.
fexofenadine	fexofenadine	Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
placebo	placebo to loratadine	Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.
loratadine	loratadine	Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point	From time of sensitization (time 0) to end of visit (~8 hours)	The individual symptom score for Runny Nose was rated on a 5-point; scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point	From time of sensitization (time 0) to end of visit (~8 hours)	The individual symptom score for Itchy Nose was rated on a 5-point; scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point	From time of sensitization (time 0) to end of visit (~8 hours)	The individual symptom score for Sneezing was rated on a 5-point; scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point	From time of sensitization (time 0) to end of visit (~8 hours)	The individual symptom score for Water Eyes was rated on a 5-point; scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Mean Individual Symptom 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.
Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point	From time of sensitization (time 0) to end of visit (~8 hours)	The individual symptom score for Nasal Congestion was rated on a 5-point; scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point	From time of sensitization (time 0) to end of visit (~8 hours)	The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point; scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.