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| Name | Class |
|---|---|
| Ergomed | INDUSTRY |
| ACM Pivotal Global Central Laboratory | INDUSTRY |
| Brecon Pharmaceuticals Ltd | UNKNOWN |
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The purpose of this trial is to investigate the tolerability of Osiris Phleum pratense used with 2 simplified up-dosing schedules compared to the up-dosing schedule used in current practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osiris Phleum pratense - Group A | Active Comparator | Group A up-dosing schedule from 1IR (index of Reactivity) /day to 240 IR/day in 11 days and thereafter 300 IR/day in 19 days. Day 1-6: 1,2,4,6,8,10 IR/day Day 7-11: 30, 60, 120, 180, 240 IR/day Day 12-30: 300 IR/day |
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| Osiris Phleum pratense - Group B | Active Comparator | Group B Up-dosing schedule: Day 1-5: 50 IR/day Day 6-10: 150 IR/day Day 11-30: 300 IR/day |
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| Osiris Phleum pratense - Group C | Active Comparator | Group C up-dosing schedule: Day 1-10: 50 IR/day Day 11-20: 150 IR/day Day 21-30: 300 IR/day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osiris Phleum pratense | Biological |
| ||
| Osiris Phleum pratense |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability based on reporting of adverse events | Recording of adverse events are performed during the entire trial period, from screening to final follow-up contact. | An average of 42 days per subject |
| Measure | Description | Time Frame |
|---|---|---|
| Subject satisfaction | To compare the subjects' satisfaction of the different dosing schedules at end of the trial (after 30 days of treatment with trial medication). | Measured at "End of treatment/end of trial Visit" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Piotr Kuna, Prof.med | Uniwersytecki Szpital Kliniczny Nr1, Lodz, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Poradnia Alergologii i Chorob Pluc Uniwersyteckiego Szpitala Klinicznego Nr1 im. N. Barlickiego w Lodzi | Lodz | 90-153 | Poland |
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| Biological |
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| Osiris Phleum pratense | Biological |
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