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This study investigates the effects of Allergic Rhinitis (AR) on driving ability and memory functions. Our group has previously shown that patients suffering from AR symptoms perform less well on tasks requiring sustained attention compared to non symptomatic controls. Car driving is a typical behavior that is susceptible for changes in sustained attention and might therefore become worse under conditions when patients suffer from AR symptoms. We will compare the driving performance of untreated, symptomatic AR patients with the performance of symptomatic patients that have been treated with either a systemic AR medication (a pill) or a topical medication (nasal spray)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pollen provocation with systemic treatment | Experimental | Subjects are treated with Cetirizine 10 mg after a nasal challenge with a pollen solution |
|
| Pollen provocation with topical treatment | Experimental | treatment with 25ug fluticasone furoate after a nasal pollen challenge |
|
| placebo treatment after pollen challenge | Placebo Comparator | Placebo treatment after a nasal challenge with pollen solution |
|
| control condition | No Intervention | A placebo drug is administered after a sham nasal challenge with a pollen solution |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetirizine 10 mg | Drug | cetirizine 10 mg over encapsulated |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Standard Deviation of Lateral Position (SDLP) in highway driving | Standard Deviation of Lateral Position (SDLP) is the amount of "weaving" that occurs when a person is driving in a straight line on the highway and instructed to maintain a steady speed and position within the lane he/she is driving | 2:00 - 3:00 hrs post dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Word Learning Test (WLT-15) verbal memory score | Subjects are presented with a list of 15 words at a rate of one word/second with a pause between words of one second. Immediately following the presentation subjects are asked to recall and name as many words as possible. The total number of words recalled after three repeated presentations of the same list of words is the outcome variable | 2:30 hrs post dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Limburg | 62ooMD | Netherlands |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017332 | Cetirizine |
| C523187 | fluticasone furoate |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| fluticasone furoate |
| Drug |
nasal spray 25ug per dose |
|
| placebo | Drug | a placebo nasal spray and placebo capsule are available for double dummy treatment |
|
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |