Status:
COMPLETED
Is Levocetirizine Less Sedating Than Cetirizine?
Lead Sponsor:
Vanderbilt University
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-77 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether cetirizine (zyrtec), levocetirizine (xyzal), and placebo differ in the degree of sedation they produce and their relief of allergy symptoms.
Detailed Description
Levocetirizine, the R-enantiomer of cetirizine, has been found to be less sedating relative to placebo than was cetirizine in separate trials. We plan to examine whether patients who did not tolerate ...
Eligibility Criteria
Inclusion
- patients 18 years of age or older
- patients with perennial allergic rhinitis sensitized (positive RAST within the last 3 years or wheal greater than or equal to 3 mm within the last 3 years) to either:
- dust mite
- cat (if they own an indoor cat)
- dog (if they own an indoor dog)
- will allow for sensitization to tree, grass, or weed pollen, cockroach, or mold
- history of reported sedation/somnolence when taking cetirizine
- patient must have taken cetirizine for at least 1 week prior to discontinuing it
- patients must have either tolerated levocetirizine in the past or have never tried levocetirizine.
Exclusion
- chronic urticaria requiring ongoing antihistamine or steroid treatment
- atopic dermatitis requiring ongoing antihistamine or steroid treatment
- URI or sinus infection during the 2 weeks preceding the beginning of the study
- vasomotor (non-allergic) or irritant rhinitis
- afrin use
- elderly or over 77 years of age (could affect creatinine clearance) or chronic renal insufficiency
- patients who have not tolerated levocetirizine in the past due to sedation.
- taking other prescription or over the counter antihistamines and unwilling to stop them during the study
- the presence of a sleep disorder such as sleep apnea or narcolepsy
- the use of as needed sleeping aid medication
- the presence of other chronic medical conditions which in the opinion of the investigator would prevent the subject from being able to participate effectively
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00826943
Start Date
January 1 2009
End Date
May 1 2009
Last Update
February 20 2014
Active Locations (1)
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1
Vanderbilt University Asthma, Sinus, and Allergy Clinic
Nashville, Tennessee, United States, 37203