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| Name | Class |
|---|---|
| Orexo AB | INDUSTRY |
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This is a phase II study in patients with seasonal allergic rhinitis (SAR) and will compare the effect versus placebo of two different oral doses of BLX-028914 in an allergen challenge model. BLX-028914, a selective phosphodiesterase-4 (PDE4) inhibitor with a promising safety profile,is currently under development for treatment of airway diseases by Orexo AB, Sweden.
The aim of this study is to compare the effect, safety and tolerability of 14 days treatment with BLX-0289014 in patients with SAR in an allergen challenge model versus placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | BLX-028914 50 mg |
|
| B | Experimental | BLX-028914 15 mg |
|
| C | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BLX-028914 | Drug | 50 mg capsules, p.o, daily, 14 days |
| |
| BLX-028914 |
| Measure | Description | Time Frame |
|---|---|---|
| Post allergen challenge; Total Nasal Symptom Score(TNSS) | 10 minutes after allergen challenge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lennart Greiff, MD, PhD | Department of otorhinolaryngology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of otorhinolaryngology | Lund | 221 85 | Sweden |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| Drug |
15 mg capsules, p.o, daily, 14 days |
|
| placebo | Drug | capsules, p.o, daily, 14 days |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |