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Completed

NCT Number: NCT00826943

Is Levocetirizine Less Sedating Than Cetirizine?

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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Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Asthma, Sinus, and Allergy Clinic

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cetirizine

Drug

Cetirizine 10 mg tab daily x 7 days

Levocetirizine

Drug

5 mg tab daily x 7 days

Placebo

Drug

Placebo tablet daily x 7 days

Primary outcomes

  1. Modified Epworth Sleepiness Scale

    Time frame: 36 days of the study

    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.

  2. Likert Score Rating Global Sedation

    Time frame: duration of study (36 days)

    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.

Secondary outcomes

  1. Total Four Symptom Scores (Allergy Symptoms)

    Time frame: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Jan 22, 2009
Registry last updated
Feb 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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