NCT00826943

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
4.8 years until next milestone

Results Posted

Study results publicly available

February 20, 2014

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

4 months

First QC Date

January 20, 2009

Results QC Date

June 25, 2009

Last Update Submit

February 19, 2014

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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)

Secondary Outcomes (1)

  • Total Four Symptom Scores (Allergy Symptoms)

    same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)

Study Arms (3)

Levocetirzine

ACTIVE COMPARATOR

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

Drug: Levocetirizine

cetirizine

ACTIVE COMPARATOR

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

Drug: Cetirizine

placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

CetirizineDRUG

Cetirizine 10 mg tab daily x 7 days

cetirizine
LevocetirizineDRUG

5 mg tab daily x 7 days

Levocetirzine
PlaceboDRUG

Placebo tablet daily x 7 days

placebo

Eligibility Criteria

Age18 Years - 77 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Asthma, Sinus, and Allergy Clinic

Nashville, Tennessee, 37203, United States

Location

Related Publications (3)

  • 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.

    PMID: 11167352BACKGROUND

  • 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.

    PMID: 15853959BACKGROUND

  • 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.

    PMID: 15480324BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Cetirizinelevocetirizine

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Douglas Tzanetos
Organization
Vanderbilt University
dtzanetos@hotmail.com
615-942-7971

Study Officials

  • Douglas B Tzanetos, M.D.

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • John M Fahrenholz, M.D.

    Vanderbilt University Medical Center

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fellow

Study Record Dates

First Submitted

January 20, 2009

First Posted

January 22, 2009

Study Start

January 1, 2009

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

February 20, 2014

Results First Posted

February 20, 2014

Record last verified: 2014-02

Locations

US(1)