Is Levocetirizine Less Sedating Than Cetirizine?

Condition(s) targeted: Allergic Rhinitis

Intervention: Cetirizine (Drug); Levocetirizine (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Vanderbilt University

Official(s) and/or principal investigator(s):
Douglas B Tzanetos, M.D., Principal Investigator, Affiliation: Vanderbilt University
John M Fahrenholz, M.D., Study Chair, Affiliation: Vanderbilt University

Overall contact:
Douglas B Tzanetos, M.D., Phone: 615-936-2727, Email: douglas.tzanetos@vanderbilt.edu

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.

Official title: Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-Blind, Placebo Controlled Trial.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Efficacy Study

Primary outcome: sedation as measured by modified Epworth Sleepiness Scale Score and a global sedation 9 point likert scale

Secondary outcome: Total Nasal Symptom Scores (allergic rhinitis symptoms)

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.

Minimum age: 18 Years. Maximum age: 77 Years. Gender(s): Both.

Criteria:

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

Douglas B Tzanetos, M.D., Phone: 615-936-2727, Email: douglas.tzanetos@vanderbilt.edu

Vanderbilt University Asthma, Sinus, and Allergy Clinic, Nashville, Tennessee 37203, United States; Recruiting
Douglas B Tzanetos, M.D., Phone: 615-936-2727, Email: douglas.tzanetos@vanderbilt.edu
John M Fahrenholz, M.D., Phone: 615-936-2727, Email: john.m.fahrenholz@vanderbilt.edu
Douglas B. Tzanetos, M.D., Principal Investigator

Related 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.

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.

Bachert C, Bousquet J, Canonica GW, Durham SR, Klimek L, Mullol J, Van Cauwenberge PB, Van Hammée 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.

Starting date: January 2009
Ending date: May 2009
Last updated: January 21, 2009