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| Name | Class |
|---|---|
| M et P Pharma AG | UNKNOWN |
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The aim of this study is to assess if a physical barrier, created by the nasal gel Nascum®- Plus, is able to prevent or minimize the induction of nasal symptoms during allergen challenge in the Fraunhofer Allergen Challenge Chamber (ACC). Furthermore, the effect on soluble and cellular inflammatory markers induced by the allergic reaction will be assessed. Nascum®-Plus contains no active pharmaceutical ingredient, only monographed pharmaceutical excipients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nascum Plus and ACC | Experimental | In a cross-over design, patients are exposed to pollen in the ACC twice for 4 hours each 3 weeks apart. Subjects will receive treatment with Nascum Plus either 5 minutes before the first or the second 4 hour pollen challenge. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nascum Plus | Drug | nasal application of nascum plus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nasal Symptom Score (TNSS) | Change of TNSS assessed during grass pollen challenge in ACC | pre start of challenge and every 20 minutes during 4 hours challenge |
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Inclusion Criteria:
Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philipp Badorrek, MD | The Fraunhofer-Gesellschaft | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fraunhofer ITEM | Hanover | Lower Saxony | 30625 | Germany |
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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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| ACC |
| Other |
4 hours challenge to grass pollen in the allergen challenge chamber (ACC) |
|
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |