Is Levocetirizine Less Sedating Than Cetirizine?

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00826943
• Other study ID #: 080829
• Status: Completed
• Phase: Phase 4
• First received: January 20, 2009
• Last updated: February 19, 2014
• Start date: January 2009
• Est. completion date: May 2009

Study information

• Verified date: February 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 77 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis

Intervention

Drug:
• Cetirizine
Cetirizine 10 mg tab daily x 7 days
• Levocetirizine
5 mg tab daily x 7 days
• Placebo
Placebo tablet daily x 7 days

Locations

Country	Name	City	State
United States	Vanderbilt University Asthma, Sinus, and Allergy Clinic	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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)	No
Secondary	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)	No