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

Tracking Information
First Submitted Date ICMJE	November 8, 2011
First Posted Date ICMJE	November 10, 2011
Results First Submitted Date	February 12, 2013
Results First Posted Date	March 22, 2013
Last Update Posted Date	March 11, 2015
Study Start Date ICMJE	October 2011
Actual 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) ]; 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) ]; 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) ]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) ]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) ]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) ]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) ]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) ]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) ]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) ]; 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; Intervention Model: Parallel Assignment; Masking: Double (Participant, 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 Arms	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
Actual Enrollment ICMJE; (submitted: February 12, 2013)	255
Original Estimated Enrollment ICMJE; (submitted: November 8, 2011)	450
Actual Study Completion Date	November 2011
Actual 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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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 ( Other Identifier: Consumer Health Care ); P08712 ( Other Identifier: Merck )
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Bayer
Study Sponsor ICMJE	Bayer
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	Bayer
Verification Date	February 2015
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP