Is Levocetirizine Less Sedating Than Cetirizine?

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Levocetirzine

5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo)

Group Type ACTIVE_COMPARATOR

Levocetirizine

Intervention Type DRUG

5 mg tab daily x 7 days

cetirizine

10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo.

Group Type ACTIVE_COMPARATOR

Cetirizine

Intervention Type DRUG

Cetirizine 10 mg tab daily x 7 days

placebo

one tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet daily x 7 days

Interventions

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Cetirizine

Cetirizine 10 mg tab daily x 7 days

Intervention Type DRUG

Levocetirizine

5 mg tab daily x 7 days

Intervention Type DRUG

Placebo

Placebo tablet daily x 7 days

Intervention Type DRUG

Eligibility 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No