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| ID | Type | Description | Link |
|---|---|---|---|
| P2FZ07001 |
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| Name | Class |
|---|---|
| Allied Research International | INDUSTRY |
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The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Bilastine oral 20 mg once per day (1 x 20 mg bilastine tablet plus 1 placebo tablet) |
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| 2 | Experimental | Bilastine oral 20 mg twice per day (2 x 20 mg bilastine tablets) |
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| 3 | Experimental | Bilastine oral 10 mg once per day (1 x 10 mg bilastine tablet plus 1 placebo tablet) |
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| 4 | Experimental | Bilastine oral 10 mg twice per day (2 x 10 mg bilastine tablets) |
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| 5 | Placebo Comparator | Placebo oral twice per day (2 placebo tablets) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilastine | Drug | Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Scores (TNSS) | within 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Total Symptom Scores (TSS), Total Non-Nasal Symptom Scores (TNNSS), Total Ocular Symptoms Scores (TOSS), Area Under the Curve (AUC) of TNSS, TSS, TOSS, TNNSS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ - EEC) | witin 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roman Valiente, MD | Faes Farma, S.A. | Study Chair |
| Piyush Patel, MD | Allied Research International Inc | Study Director |
| Deepen Patel, MD, CCFP | Allied Research International Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Allied Research International - Cetero Research | Mississauga | Ontario | 905-238-0599 | Canada |
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| Placebo | Drug | Placebo Tablets administered twice per day |
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| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C445659 | bilastine |
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