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The purpose of the study is to evaluate the efficacy and safety of grass pollen-derived peptides administrated orally to treat seasonal allergic rhinoconjunctivitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| gpASIT400 | Experimental | gpASIT+TM 400 µg |
|
| gpASIT800 | Experimental | gpASIT+TM 800 µg |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gpASIT+TM | Biological | entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of gpASIT+TM on the clinical efficacy of the subjects | The following parameter will be assessed: rhinoconjunctivitis total symptom score | grass pollen season 2011 (April to July) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical tolerability and safety of the treatment | The following parameters will be assessed: general physical status, vital signs, haematological parameters, general blodd biochemistry parameters, all (serious) adverse events, immunological analysis (total IgG, IgE) and inflammatory parameters (CRP, sedimentation rate) | 8 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claus Bachert, MD | UZ Ghent | Principal Investigator |
| Jan Ceuppens, MD | UZ Leuven | Principal Investigator |
| Didier Ebo, MD | UZ Antwerpen | Principal Investigator |
| Jean-Luc Halloy, MD | CHR Warquignies | Principal Investigator |
| Stijn Hallewyck, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Peter Hellings, MD | UZ Leuven | Principal Investigator |
| Renaud Louis, MD | Centre Hospitalier Universitaire de Liege | Principal Investigator |
| Catherine Mbasoa, MD | Clinique du Parc Léopold Bruxelles | Principal Investigator |
| Charles Pilette, MD | UCL Saint Luc Bruxelles | Principal Investigator |
| Hélène Simonis, MD | CHR Citadelle Liège |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHR Saint Joseph Warquignies | Boussu | 7300 | Belgium | |||
| AZ Sint Lucas |
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| gpASIT+TM | Biological | entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days |
|
| Placebo | Biological | Placebo entero-coated capsules |
|
| Impact of gpASIT+TM on the immunological status of the subjects |
The following parameter will be assessed: allergen-specific immunoglobulin concentrations |
| screening visit (January-February 2011), before pollen season (April 2011), during pollen season (June 2011) and after pollen season (August 2011) |
| Impact of gpASIT+TM on the clinical status of the subjects | The average daily symptom and rescue medication scores will be assessed. | grass pollen season 2011 (April-July) |
| Impact of gpASIT+TM on the quality of life of the subjects | The quality of life will be assessed by the use of validated questionnaires. | grass pollen season 2011 (April-July) |
| Principal Investigator |
| Olivier Vandenplas, MD | UCL Mont Godinne Yvoir | Principal Investigator |
| Christoph Verhoye, MD | AZ Sint-Lucas Brugge | Principal Investigator |
| Patricia Wackenier, MD | CHU Ambroise-Paré - Mons | Principal Investigator |
| Frédéric De Blay, MD | CHRU Strasbourg | Principal Investigator |
| Marie-Christine Castelain, MD | Hôpital Saint Vincent de Paul, Lille | Principal Investigator |
| François Lavaud, MD | CHRU Reims | Principal Investigator |
| Benoît Wallaert, MD | CHU Lille | Principal Investigator |
| François Wessel, MD | Private Practice Nantes | Principal Investigator |
| Bruno Lebeaupin, MD | Private Practice Nantes | Principal Investigator |
| François Hentges, MD | CHL Luxembourg | Principal Investigator |
| François Durand Perdriel, MD | Private Practice Nantes | Principal Investigator |
| François Spirlet, MD | CH de Dinant | Principal Investigator |
| Bruges |
| 8310 |
| Belgium |
| Clinique du Parc Léopold | Brussels | 1040 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| UCL Saint Luc | Brussels | 1200 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| CHR Citadelle | Liège | 4000 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| CHU Ambroise Paré | Mons | 7000 | Belgium |
| UCL Mont Godinne | Yvoir | 5530 | Belgium |
| Hôpital Saint Vincent de Paul | Lille | 59020 | France |
| CHRU Lille | Lille | 59037 | France |
| Private practice | Nantes | 44000 | France |
| Private practice | Nantes | 44400 | France |
| CHU Reims | Reims | 51100 | France |
| CHRU Strasbourg | Strasbourg | 67091 | France |
| CH Luxembourg | Luxembourg | 1210 | Luxembourg |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
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