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

Purpose

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.

Condition	Intervention	Phase
Rhinitis	Drug: loratadine Drug: fexofenadine Drug: placebo to loratadine Drug: placebo to fexofenadine	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever

Drug Information available for: Loratadine Fexofenadine Fexofenadine hydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.


Enrollment:	255
Study Start Date:	October 2011
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: loratadine Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.	Drug: loratadine loratadine, one 10 mg tablet, orally Other Name: SCH 029851 Drug: placebo to fexofenadine one tablet, orally
Experimental: fexofenadine Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.	Drug: fexofenadine fexofenadine, one 180 mg tablet, orally Drug: placebo to loratadine one tablet, orally
Placebo Comparator: placebo Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.	Drug: placebo to loratadine one tablet, orally Drug: placebo to fexofenadine one tablet, orally

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Bayer
ClinicalTrials.gov Identifier:	NCT01469234 History of Changes
Other Study ID Numbers:	18126 PT11-37 P08712
Study First Received:	November 8, 2011
Results First Received:	February 12, 2013
Last Updated:	February 20, 2015
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fexofenadine	Loratadine Terfenadine Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipruritics Dermatologic Agents

ClinicalTrials.gov processed this record on September 27, 2016