Is Levocetirizine Less Sedating Than Cetirizine?

Last updated: February 19, 2014
Sponsor: Vanderbilt University
Overall Status: Completed

Phase

4

Condition

Allergy

Common Cold

Allergy (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00826943
080829
  • Ages 18-77
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients 18 years of age or older

  • patients with perennial allergic rhinitis sensitized (positive RAST within the last 3years 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 triedlevocetirizine.

Exclusion

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 renalinsufficiency

  • patients who have not tolerated levocetirizine in the past due to sedation.

  • taking other prescription or over the counter antihistamines and unwilling to stopthem 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 theinvestigator would prevent the subject from being able to participate effectively

Study Design

Total Participants: 30
Study Start date:
January 01, 2009
Estimated Completion Date:
May 31, 2009

Study 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 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.

Connect with a study center

  • Vanderbilt University Asthma, Sinus, and Allergy Clinic

    Nashville, Tennessee 37203
    United States

    Site Not Available

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