Allergic Rhinitis
Conditions
Keywords
Allergic Rhinitis
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.
Interventions
DRUGCetirizine
Cetirizine 10 mg tab daily x 7 days
DRUGLevocetirizine
5 mg tab daily x 7 days
DRUGPlacebo
Placebo tablet daily x 7 days
Sponsors
Vanderbilt University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 77 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Epworth Sleepiness Scale | 36 days of the study | 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 | duration of study (36 days) | 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
| Measure | Time frame | Description |
|---|---|---|
| Total Four Symptom Scores (Allergy Symptoms) | same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants Cross Over (all participants received all interventions) | 29 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 37.5 years STANDARD_DEVIATION 10.9 |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: duration of study (36 days)
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Likert Score Rating Global Sedation | 2.80 Likert score | Standard Deviation 1.67 |
| Levocetirizine | Likert Score Rating Global Sedation | 3.07 Likert score | Standard Deviation 1.92 |
| Cetirizine | Likert Score Rating Global Sedation | 3.54 Likert score | Standard Deviation 2.17 |
p-value: 0.14Wilcoxon (Mann-Whitney)
p-value: 0.54Wilcoxon (Mann-Whitney)
p-value: 0.42Wilcoxon (Mann-Whitney)
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.
Time frame: 36 days of the study
Population: per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Modified Epworth Sleepiness Scale | 6.14 units on a scale | Standard Deviation 4.58 |
| Levocetirizine | Modified Epworth Sleepiness Scale | 6.69 units on a scale | Standard Deviation 4.05 |
| Cetirizine | Modified Epworth Sleepiness Scale | 7.48 units on a scale | Standard Deviation 5.31 |
p-value: 0.27Wilcoxon (Mann-Whitney)
p-value: 0.8Wilcoxon (Mann-Whitney)
p-value: 0.52Wilcoxon (Mann-Whitney)
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.
Time frame: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Total Four Symptom Scores (Allergy Symptoms) | 4.41 TFSS scores | Standard Deviation 3.76 |
| Levocetirizine | Total Four Symptom Scores (Allergy Symptoms) | 3.14 TFSS scores | Standard Deviation 2.67 |
| Cetirizine | Total Four Symptom Scores (Allergy Symptoms) | 2.67 TFSS scores | Standard Deviation 2.44 |
p-value: 0.03Wilcoxon (Mann-Whitney)
p-value: 0.11Wilcoxon (Mann-Whitney)
p-value: 0.45Wilcoxon (Mann-Whitney)