Is Levocetirizine Less Sedating Than Cetirizine? - Full Text View

Sponsor:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00826943

Purpose

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.

Condition	Intervention	Phase
Allergic Rhinitis	Drug: Cetirizine Drug: Levocetirizine Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-Blind, Placebo Controlled Trial.

Resource links provided by NLM:

Drug Information available for: Cetirizine Cetirizine hydrochloride Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

sedation as measured by modified Epworth Sleepiness Scale Score and a global sedation 9 point likert scale [ Time Frame: at end of each wash out period (5 days) and each intervention period (7 days) for total of 6 times over the course of 36 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Total Nasal Symptom Scores (allergic rhinitis symptoms) [ Time Frame: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36) ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2009
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Cetirizine Cetirizine 10 mg tab daily x 7 days
Experimental: 2	Drug: Levocetirizine 5 mg tab daily x 7 days
Placebo Comparator: 3	Drug: Placebo Placebo tablet daily x 7 days

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

Ages Eligible for Study:	18 Years to 77 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826943

Contacts

Contact: Douglas B Tzanetos, M.D.	615-936-2727	douglas.tzanetos@vanderbilt.edu
Contact: John M Fahrenholz, M.D.	615-936-2727	john.m.fahrenholz@vanderbilt.edu

Locations

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

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:	Douglas B Tzanetos, M.D.	Vanderbilt University
Study Chair:	John M Fahrenholz, M.D.	Vanderbilt University

More Information

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.

Responsible Party:	Douglas Tzanetos, M.D., allergy/immunology fellow, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00826943 History of Changes
Other Study ID Numbers:	080829
Study First Received:	January 20, 2009
Last Updated:	January 21, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Allergic Rhinitis

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Cetirizine
Levocetirizine
Anti-Allergic Agents
Therapeutic Uses

Pharmacologic Actions
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2012