Is Levocetirizine Less Sedating Than Cetirizine?

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

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.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Levocetirizine; Drug: Cetirizine; Drug: Placebo

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 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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Vanderbilt University Asthma, Sinus, and Allergy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Douglas B Tzanetos, M.D., Vanderbilt University Medical Center; Study Chair: John M Fahrenholz, M.D., Vanderbilt University Medical Center

Publications and helpful links

General Publications

• Devalia JL, De Vos C, Hanotte F, Baltes E. A randomized, double-blind, crossover comparison among cetirizine, levocetirizine, and ucb 28557 on histamine-induced cutaneous responses in healthy adult volunteers. Allergy. 2001 Jan;56(1):50-7. doi: 10.1034/j.1398-9995.2001.00726.x.
• de Blic J, Wahn U, Billard E, Alt R, Pujazon MC. Levocetirizine in children: evidenced efficacy and safety in a 6-week randomized seasonal allergic rhinitis trial. Pediatr Allergy Immunol. 2005 May;16(3):267-75. doi: 10.1111/j.1399-3038.2005.00216.x.
• Bachert C, Bousquet J, Canonica GW, Durham SR, Klimek L, Mullol J, Van Cauwenberge PB, Van Hammee G; XPERT Study Group. Levocetirizine improves quality of life and reduces costs in long-term management of persistent allergic rhinitis. J Allergy Clin Immunol. 2004 Oct;114(4):838-44. doi: 10.1016/j.jaci.2004.05.070.

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: January 20, 2009
• First Submitted That Met QC Criteria: January 21, 2009
• First Posted (Estimate): January 22, 2009

Study Record Updates

• Last Update Posted (Estimate): February 20, 2014
• Last Update Submitted That Met QC Criteria: February 19, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: Allergic Rhinitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Cetirizine; Levocetirizine
• Other Study ID Numbers: 080829