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):

Bayer

ClinicalTrials.gov Identifier:

NCT01469234

First received: November 8, 2011

Last updated: February 20, 2015

Last verified: February 2015

History of Changes

Tracking Information
First Received Date ^ICMJE	November 8, 2011
Last Updated Date	February 20, 2015
Start Date ^ICMJE	October 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 12, 2013)	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.
Original Primary Outcome Measures ^ICMJE (submitted: November 8, 2011)	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.
Change History	Complete list of historical versions of study NCT01469234 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 28, 2014)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: November 8, 2011)	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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Rhinitis
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	255
Completion Date	November 2011
Primary Completion Date	November 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Not Provided
Removed Location Countries	United States

Administrative Information
NCT Number ^ICMJE	NCT01469234
Other Study ID Numbers ^ICMJE	18126, PT11-37, P08712
Has Data Monitoring Committee	No
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Bayer
Study Sponsor ^ICMJE	Bayer
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bayer
Verification Date	February 2015
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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