Is Levocetirizine Less Sedating Than Cetirizine?

Study Overview
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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.

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.

Official Title
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Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-blind, Placebo Controlled Trial.

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Cetirizine
* Drug: Levocetirizine
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levocetirzine<br>5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo) | Drug: Levocetirizine<br>* 5 mg tab daily x 7 days<br>|
| Active Comparator: cetirizine<br>10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo. | Drug: Cetirizine<br>* Cetirizine 10 mg tab daily x 7 days<br>|
| Placebo Comparator: placebo<br>one tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo | Drug: Placebo<br>* Placebo tablet daily x 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Epworth Sleepiness Scale | Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36. This was mean data for all interventions. | 36 days of the study | 
| Likert Score Rating Global Sedation | Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study. This was mean data for all interventions. | duration of study (36 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Four Symptom Scores (Allergy Symptoms) | Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated. This was mean data for all interventions. | same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic Rhinitis