Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-Blind, Placebo Controlled Trial.
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37203 |
| Conditions: |
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Allergic Rhinitis |
| Purpose: |
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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.
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| Study Summary: |
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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 cetirizine due to sedation are able to tolerate levocetirizine. This study
will utilize a randomized, double-blind, placebo controlled trial comparing levocetirizine,
cetirizine, and placebo in regards to sedation and allergy symptom scores. Each patient
will receive levocetirizine, cetirizine, and placebo in randomized order and thus serve as
their own control.
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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
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| NCT ID: |
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NCT00826943 |
| Primary Contact: |
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Principal Investigator
Douglas B Tzanetos, M.D.
Vanderbilt University
Douglas B Tzanetos, M.D.
Phone: 615-936-2727
Email: douglas.tzanetos@vanderbilt.edu
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| Backup Contact: |
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Email: john.m.fahrenholz@vanderbilt.edu
John M Fahrenholz, M.D.
Phone: 615-936-2727
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| Location Contact: |
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Nashville, Tennessee 37203
United States
Douglas B Tzanetos, M.D.
Phone: 615-936-2727
Email: douglas.tzanetos@vanderbilt.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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