Clinical trial NCT00826943: Is Levocetirizine Less Sedating Than Cetirizine?
Official title: Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-blind, Placebo Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility 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

Primary outcomes:
measure: Modified Epworth Sleepiness Scale
timeFrame: 36 days of the study
measure: Likert Score Rating Global Sedation
timeFrame: duration of study (36 days)
Secondary outcomes:
measure: Total Four Symptom Scores (Allergy Symptoms)
timeFrame: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Asthma, Sinus, and Allergy Clinic
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Douglas B Tzanetos, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: John M Fahrenholz, M.D.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.