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Is Levocetirizine Less Sedating Than Cetirizine?

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cetirizine
Levocetirizine
Placebo
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic Rhinitis

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt University Asthma, Sinus, and Allergy Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Levocetirzine

cetirizine

placebo

Arm Description

5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo)

10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo.

one tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 20, 2009
Last Updated
February 19, 2014
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00826943
Brief Title
Is Levocetirizine Less Sedating Than Cetirizine?
Official Title
Is Levocetirizine Less Sedating Than Cetirizine? A Randomized, Double-blind, Placebo Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Levocetirzine
Arm Type
Active Comparator
Arm Description
5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo)
Arm Title
cetirizine
Arm Type
Active Comparator
Arm Description
10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
one tablet daily x 7 days; note that this is a crossover study so all participants receive all active comparators and placebo
Intervention Type
Drug
Intervention Name(s)
Cetirizine
Intervention Description
Cetirizine 10 mg tab daily x 7 days
Intervention Type
Drug
Intervention Name(s)
Levocetirizine
Intervention Description
5 mg tab daily x 7 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet daily x 7 days
Primary Outcome Measure Information:
Title
Modified Epworth Sleepiness Scale
Description
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.
Time Frame
36 days of the study
Title
Likert Score Rating Global Sedation
Description
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.
Time Frame
duration of study (36 days)
Secondary Outcome Measure Information:
Title
Total Four Symptom Scores (Allergy Symptoms)
Description
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.
Time Frame
same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas B Tzanetos, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John M Fahrenholz, M.D.
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt University Asthma, Sinus, and Allergy Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11167352
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.
Results Reference
background
PubMed Identifier
15853959
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.
Results Reference
background
PubMed Identifier
15480324
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.
Results Reference
background

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Is Levocetirizine Less Sedating Than Cetirizine?

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