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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Levocetirzine | Active Comparator | 5 mg daily x 7 days (note = cross over = all participants receive active comparators and placebo) |
|
| cetirizine | Active Comparator | 10 mg daily x 7 days. Note = crossover study, so all participants recieve all active comparators and placebo. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetirizine | Drug | Cetirizine 10 mg tab daily x 7 days |
| |
| Levocetirizine |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas B Tzanetos, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| John M Fahrenholz, M.D. | Vanderbilt University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Asthma, Sinus, and Allergy Clinic | Nashville | Tennessee | 37203 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11167352 | Background | 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. | |
| 15853959 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | L Then C Then P | Levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each) |
| FG001 | L Then P Then C | Levocetirizine 5 mg daily x 7 days then placebo daily x 7 days then cetiriznie 10 mg daily x 7 days (wash out periods before and after each) |
| FG002 | P Then L Then C | placebo daily x 7 days then levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days (wash out periods before and after each) |
| FG003 | P Then C Then L | placebo daily x 7 days then cetirizine 10 mg daily x 7 days then levocetirizine daily x 7 days (wash out periods before and after each) |
| FG004 | C Then L Then P | cetirizine 10 mg daily x 7 days then levocetirizine 5 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each) |
| FG005 | C Then P Then L | cetirizine 10 mg daily x 7 days then placebo daily x 7 days then levocetirizine 5 mg daily x 7 days (wash out periods before and after each) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Cross Over (all participants received all interventions) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | TFSS scores | same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Cross Over (all participants received all interventions) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Douglas Tzanetos | Vanderbilt University | 615-942-7971 | dtzanetos@hotmail.com |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D017332 | Cetirizine |
| C472067 | levocetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
5 mg tab daily x 7 days |
|
| Placebo | Drug | Placebo tablet daily x 7 days |
|
| 15480324 | Background | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Cetirizine | cross over = all participants received all interventions |
|
|
|
| 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. | per protocol | Posted | Mean | Standard Deviation | units on a scale | 36 days of the study |
|
|
|
|
| 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. | per protocol | Posted | Mean | Standard Deviation | Likert score | duration of study (36 days) |
|
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Levocetirizine | cross over (all participants received all interventions) | 0 | 30 | 0 | 30 |
| EG002 | Cetirizine | cross over = all participants received all interventions | 0 | 30 | 0 | 30 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
The threshold for significance was p < 0.05. |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | .52 | The threshold for significance was p < 0.05. | No | Superiority or Other |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | .42 | No | Superiority or Other |