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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-003004-19 | EudraCT Number |
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This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.
The objective of the study is to determine the effect of a single dose of bilastine 20 mg on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber . This effect will be compared to that action of Cetirizine 10 mg, Fexofenadine 120 mg, and placebo. To explore the onset of action, patients will receive study drug two hours after the start of the provocation on Day 1.Patients will remain in theVCC for an additional four hours. On Day 2, patients will return to the VCC post-dose hours 22-26.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bilastine 20 mg |
|
| 2 | Active Comparator | Fexofenadine 120 mg |
|
| 3 | Active Comparator | Cetirizine 10 mg |
|
| 4 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilastine | Drug | Encapsulated Bilastine 20 mg tablets Q.D. |
| |
| Fexofenadine |
| Measure | Description | Time Frame |
|---|---|---|
| Onset of action and action duration |
| Measure | Description | Time Frame |
|---|---|---|
| Nasal and ocular symptom scores | ||
| Nasal airflow resistance | ||
| Nasal secretion weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Friedrich Horak, Professor | ENT University Clinic Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allergy Center Vienna West | Vienna | A-1150 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19943178 | Result | Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010 May;59(5):391-8. doi: 10.1007/s00011-009-0117-4. Epub 2009 Nov 27. |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| C445659 | bilastine |
| C093230 | fexofenadine |
| D017332 | Cetirizine |
| ID | Term |
|---|---|
| D006919 | Hydroxyzine |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
Encapsulated Fexofenadine 120 mg tablets Q.D. |
|
|
| Cetirizine | Drug | Encapsulated Cetirizine 10 mg tablets Q.D. |
|
|
| Placebo | Drug | Encapsulated Placebo tablets Q.D. |
|
| FEV1 |
| Routine safety parameters (vital signs, ECGs, clinical laboratory tests) |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |