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This study will be performed to determine the long-term efficacy of 19.000 BU Oralgen grass pollen administered daily in patients with grass pollen related allergic rhinoconjunctivitis.
Patients between 18 and 60 years will be randomized to receive either Oralgen grass pollen or placebo administered sublingually once a day. Treatment will start at least 16 weeks prior to the anticipated start of the pollen season 2009 and will last until the end of the pollen season 2011. Study medication will be titrated during the first period of treatment until maintenance dose has been reached.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Grass pollen extract | Active Comparator | Subjects will receive 19.000 BU grass pollen extract daily sublingually |
|
| Placebo control | Placebo Comparator | Subjects will receive matching placebo control daily sublingually |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oralgen | Drug | 19.000 BU daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between active and placebo-group based on combined RTSS and RMS score | third season |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between active and placebo based on RTSS score | third season |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Folkert Roossien | Artu-Biologicals Europe B.V. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ St Jan, Campus Sint-Jan | Bruges | B-8000 | Belgium | |||
| Clinique Saint Luc |
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| placebo control | Other | placebo control |
|
| Brussels |
| B-1200 |
| Belgium |
| U.Z. St Raphael | Leuven | B-3000 | Belgium |
| University Hospital Leuven | Leuven | B-3000 | Belgium |
| CHR de la Citadelle | Liège | B-4000 | Belgium |
| Clinique UCL de Mont-Godinne | Yvoir | B-5530 | Belgium |
| Groupe Hospitalier Pellegrin | Bordeaux | 33000 | France |
| Gael Taburet | Brest | 29200 | France |
| Francois Durand Perdriel | Nantes | 44000 | France |
| Francois Wessel | Nantes | 44000 | France |
| Michel Anton | Nantes | 44000 | France |
| Françoise Sanquer | Quimper | 29000 | France |
| Bruno Lebeaupin | Rezé | 44400 | France |
| CHRU de Strasbourg | Strasbourg | 67091 | France |
| Mathieu Larrousse | Toulon | 83000 | France |
| Allergie-Centrum-Charité | Berlin | 10117 | Germany |
| Berufsgen. kliniken Bergmannsheil | Bochum | Germany |
| Universitätsklinik Bonn | Bonn | 53105 | Germany |
| Uniklinikum Carl Gustav Carus | Dresden | 01307 | Germany |
| Uniklinikum Frankfurt | Frankfurt am Main | 60590 | Germany |
| MedicoKIT | Goch | Germany |
| Universitätsklinikum Halle (Saale) | Halle | 06112 | Germany |
| Universitätsklinikum Schleswig-Holstein | Lübeck | 23538 | Germany |
| Klinikum der Universität München | München | 80337 | Germany |
| Universitätsklinikum Münster | Münster | 48149 | Germany |
| Rijnland Ziekenhuis, Location Alphen - Poli KNO | Alphen aan den Rijn | 2402 WC | Netherlands |
| Wilhelmina ziekenhuis | Assen | Netherlands |
| Ampha De Bilt | De Bilt | 3731 DN | Netherlands |
| Catharina Ziekenhuis | Eindhoven | 5623 EJ | Netherlands |
| AMPHA Nijmegen | Nijmegen | 6525EC | Netherlands |
| Sint Elisabeth Ziekenhuis | Tilburg | 5022 GC | Netherlands |
| Prywatna Praktyka Lekarska, Gabinet Pediatryczno Alergologiczny | Bialystok | 15-084 | Poland |
| SP-ZOZ Osrodek Zdrowia w Bienkowce | Bieńkówka | 34-212 | Poland |
| SPZOZ Wojewodzki Szpital Kliniczny im.Dr.J.Biziela | Bydgoszcz | 85-168 | Poland |
| Slaskie Centrum Osteoporozy | Katowice | 40-084 | Poland |
| SP ZOZ Uniwersytecki Szpital Kliniczny Nr 1 | Lodz | 90-153 | Poland |
| NZOZ Centrum Alergologii Prof. Buczylko | Lodz | 90-553 | Poland |
| SPZOZ Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszyńskiego | Lublin | 20-718 | Poland |
| Centrum Alergologii Teresa Hofman | Poznan | 60-214 | Poland |
| NZOZ Lekarze Specjalisci | Wroclaw | 54-239 | Poland |
| Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego w Katowicach | Zabrze | 41-800 | Poland |
| Samodzielny Publiczny Szpital Kliniczny nr 3 | Zabrze | 41-803 | Poland |
| The Alverton Practice | Penzance | Cornwall | TR18 4JH | United Kingdom |
| Saltash Health Centre | Saltash | Cornwall | PL12 6DL | United Kingdom |
| Cape Cornwall Surgery | St Just | Cornwall | TR19 7HX | United Kingdom |
| Fowey River Practice | Fowey | Cornwal | Pl23 1DT | United Kingdom |
| Sea Road Surgery | Bexhill-on-Sea | Past Sussex | TN40 1JJ | United Kingdom |
| Atherstone Surgery | Atherstone | Warwickshire | CV9 1EU | United Kingdom |
| The Porch Surgery | Corsham | Wiltshire | SN13 9DL | United Kingdom |
| Layton Medical Centre | Blackpool, Lancashire | FY3 7EN | United Kingdom |
| Brighton General Hospital | Brighton | BN2 3 EW | United Kingdom |
| Hathaway Medical Centre | Chippenham | SN14 6GT | United Kingdom |
| House Surgery | Crownhill, Plymouth | PL5 3JB | United Kingdom |
| Guy's Hospital, Guy's and St Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| St. Mary's Hospital | London | W2 1NY | United Kingdom |
| Royal National Throat, Nose & Ear Hospital | London | WC1X 8DA | United Kingdom |
| QMC Notthingham, Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Brannel Surgery | Saint Stephen, Saint Austell | PL26 7RL | United Kingdom |
| Northern General Hospital | Sheffield | S5 7AU | United Kingdom |
| Avenue Surgery | Warminster | BA12 9AA | United Kingdom |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C451253 | grass pollen extract, alum-adsorbed |
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