Healthy
Conditions
Keywords
direct-to-consumer advertising
Brief summary
The primary goal of this study is to examine determinants of the efficacy of Claritin.
Detailed description
Subjects will be given Claritin 10mg tablet. Subjects will be challenged with histamine via skin prick prior to Claritin administration and at 1 and 2 hours post administration. We will measure and record wheal and flare area 10 minutes following each challenge.
Interventions
DRUGClaritin
Subject will be given 10mg Claritin tablet.
Sponsors
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
. 1\. Males and females between 18 and 65 years of age.
Exclusion criteria
. 1. Pregnant or lactating women. 2. Upper respiratory infection within 14 days of study start. 3. Women of childbearing potential not using specific contraception method(s) (i.e., birth control pills, depo Provera, double barrier) as well as women who are breastfeeding. 4. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (heart, lung, kidney, neurological, oncologic or liver disease). 5. Use of any other investigational agent in the last 30 days. 6. Use of medications that may affect skin testing. Specifically, subjects are excluded if they have used an antihistamine during the 4 days preceding their treatment visit.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wheal Reaction Area From Baseline --- 2 Hour | baseline and 2 hours post administration of Claritin. | A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 2 hours post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm\^2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Wheal Reaction Area From Baseline --- 1 Hour | baseline and 1 hours post administration of Claritin | A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 1 hour post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm\^2. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Claritin Ads, Allergy+ Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.
Claritin: Subject will be given 10mg Claritin tablet. | 83 |
| Zyrtec Ads, Allergy+ Subject, with positive skin test to at least one common allergen (grass, trees, mold, dust mites, ragweed, cats), will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.
Claritin: Subject will be given 10mg Claritin tablet. | 87 |
| Claritin Ads, Allergy- Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Claritin.
Claritin: Subject will be given 10mg Claritin tablet. | 85 |
| Zyrtec Ads, Allergy- Subject, without allergies, will be given 10mg Claritin tablet and then watch a movie that includes commercials for Zyrtec.
Claritin: Subject will be given 10mg Claritin tablet. | 85 |
| Total | 340 |
Baseline characteristics
| Characteristic | Claritin Ads, Allergy+ | Zyrtec Ads, Allergy+ | Claritin Ads, Allergy- | Zyrtec Ads, Allergy- | Total |
|---|---|---|---|---|---|
| Age, Continuous | 27.83 years | 29.30 years | 27.25 years | 26.40 years | 27.70 years |
| Race/Ethnicity, Customized Black | 29 Participants | 35 Participants | 24 Participants | 22 Participants | 110 Participants |
| Race/Ethnicity, Customized Not Black | 54 Participants | 52 Participants | 61 Participants | 63 Participants | 230 Participants |
| Region of Enrollment United States | 83 Participants | 87 Participants | 85 Participants | 85 Participants | 340 Participants |
| Sex: Female, Male Female | 43 Participants | 51 Participants | 59 Participants | 59 Participants | 212 Participants |
| Sex: Female, Male Male | 40 Participants | 36 Participants | 26 Participants | 26 Participants | 128 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 83 | 0 / 87 | 0 / 85 | 0 / 85 |
| serious Total, serious adverse events | 0 / 83 | 0 / 87 | 0 / 85 | 0 / 85 |
Outcome results
Primary
Change in Wheal Reaction Area From Baseline --- 2 Hour
A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 2 hours post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm\^2.
Time frame: baseline and 2 hours post administration of Claritin.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Claritin Ads, Allergy+ | Change in Wheal Reaction Area From Baseline --- 2 Hour | 27.5 Percent change | Standard Error 2.5 |
| Zyrtec Ads, Allergy+ | Change in Wheal Reaction Area From Baseline --- 2 Hour | 29.0 Percent change | Standard Error 2.5 |
| Claritin Ads, Allergy- | Change in Wheal Reaction Area From Baseline --- 2 Hour | 30.97 Percent change | Standard Error 2.4 |
| Zyrtec Ads, Allergy- | Change in Wheal Reaction Area From Baseline --- 2 Hour | 25.0 Percent change | Standard Error 2.5 |
Secondary
Change in Wheal Reaction Area From Baseline --- 1 Hour
A research technician, blinded to the subject's condition, measured the extent of the skin inflammation at baseline and 1 hour post Claritin administration by tracing the wheal reaction after the histamine challenge (i.e. the slightly reddened, elevated area at the site of the challenge, a well-established measure of histamine response). The percentage change in the wheal reaction was calculated as the change (decrease) in the size relative to baseline, multiplied by 100. Wheal area was measured in mm\^2.
Time frame: baseline and 1 hours post administration of Claritin
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Claritin Ads, Allergy+ | Change in Wheal Reaction Area From Baseline --- 1 Hour | 10.8 Percent change | Standard Error 2 |
| Zyrtec Ads, Allergy+ | Change in Wheal Reaction Area From Baseline --- 1 Hour | 17.5 Percent change | Standard Error 2.5 |
| Claritin Ads, Allergy- | Change in Wheal Reaction Area From Baseline --- 1 Hour | 14.18 Percent change | Standard Error 3 |
| Zyrtec Ads, Allergy- | Change in Wheal Reaction Area From Baseline --- 1 Hour | 10.83 Percent change | Standard Error 3 |