A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis
Intervention: loratadine (Drug); fexofenadine (Drug); placebo to loratadine (Drug); placebo to fexofenadine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Bayer
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes)
Secondary outcome: Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time PointMean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: October 2011
Last updated: February 20, 2015
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