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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002477-31 | EudraCT Number |
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This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.
Allergy is one of the most common chronic diseases. Allergies to grass, weed, and tree pollens characteristically result in seasonal rhinitis symptoms commonly termed hay fever. The risk of developing asthma has been noted to be higher in patients with rhinitis than among the general population (10% versus 3.6%), confirming the fact that rhinitis is often the first step of the natural history of asthma.
Although several drugs effectively manage the symptoms of allergic rhinitis, conjunctivitis or asthma, they do not represent an etiopathogenic treatment of the considered diseases, and do not prevent the reappearance of the symptoms at the end of the treatment.
Immunotherapy is generally considered to be appropriate for patients in whom rhinitis symptoms cannot be controlled by an optimal medication regimen and avoidance of the allergens. At present, specific immunotherapy is the only therapy available that acts on the main cause of the allergic reaction by modifying or down-regulating the immune response.
Allergen immunotherapy is the administration of gradually increasing quantities of an allergen vaccine (extract) to an allergic subject, to reach a maintenance dose, which is effective in reducing the symptoms associated with exposure to the causative allergen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo control | Placebo Comparator | Placebo control |
|
| Grass pollen extract, twice weekly | Active Comparator | Grass pollen extract, 9,500 BU, given twice weekly |
|
| Grass pollen extract daily | Active Comparator | Grass pollen extract, 9,500 BU, given daily |
|
| Increased dose of grass pollen extract | Active Comparator | Increased dose of grass pollen extract, 19,000 BU, given daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oralgen | Drug | allergen solution sublingually |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pollen Season Rhinoconjunctivitis Total Symptom Score | site specific pollen season |
| Measure | Description | Time Frame |
|---|---|---|
| Rescue medication usage | one year | |
| Proportion of symptom-free days during the pollen season | one year | |
| Rhinoconjunctivitis QoL Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dyonne van Duren, MD, PhD | AMPHA Nijmegen, Toernooiveld 220, 6525EC, Nijmegen, The Netherlands | Principal Investigator |
| Knut Schaekel, MD, PhD | Universitait Klinikum Carl Gustav Carus, Fetscherstrasse 74, SN 01307, Dresden, Germany | Principal Investigator |
| Iveta Kozlovska, MD, PhD | Centrum Immunologie a allergologie, Pavla Horova 14, 84108 Bratislava, Slovak Republic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT PLovdiv, ENT Clinic | Plovdiv | Bulgaria | ||||
| Military Medical Academy, Clinic of ENT |
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|
| placebo | Other | placebo control |
|
|
| one year |
| Global evaluation of the efficacy by the patient | one year |
| Local and systemic tolerability and other adverse events, labor | one year |
| Sofia |
| 1606 |
| Bulgaria |
| Military Medical Academy | Sofia | 1606 | Bulgaria |
| 5th MHAT, ENT Clinic | Sofia | Bulgaria |
| Ministry of interior-central clinical database | Sofia | Bulgaria |
| MHAT Sveta Marina | Varna | Bulgaria |
| Military Medical Academy | Varna | Bulgaria |
| ORL Soukroma praxe | Brno | Czechia |
| Fakultni nemocnice Brno | Brno-Bohunice | Czechia |
| Nemocnice Caslav | Čáslav | Czechia |
| Alergologicka ordinace | Dobruška | Czechia |
| Alergologicka ambulance | Jablonec nad Nisou | 466 04 | Czechia |
| Alergologicka ordinace | Kutná Hora | 284 01 | Czechia |
| Alergologicka ambulance | Ostrava - Hrabuvka | Czechia |
| Ambulance plicni a alergologicka | Ostrave - Hrabuvka | Czechia |
| Alergologicka ambulance Okresni nemocnice Tabor | Tábor | Czechia |
| Berufsgen. kliniken Bergmannsheil | Bochum | Germany |
| Univ. klinikum Carl Gustav Carus | Dresden | Germany |
| MedicoKIT | Goch | Germany |
| Johannes-Gutenberg-Universitat Mainz | Mainz | Germany |
| Vital Care | München | Germany |
| Privataertz. inst. & Forsh. einrichtung | Wiesbaden | Germany |
| Svabhegyi Allami Gyermekgyogyintezet pulmonologia | Budapest | Hungary |
| Szent Janos Korhaz | Budapest | Hungary |
| Selye Janos Korhaz | Komárom | Hungary |
| Karolina Korhaz | Mosomagyarovar | Hungary |
| Tudogyogyintezet Torokbalint | Törökbálint | Hungary |
| Kaunas medical University hospital | Kaunas | Lithuania |
| JSC Seimos gydytojas | Vilnius | Lithuania |
| Vilnius Central Outpatient Clinic | Vilnius | Lithuania |
| Vilnius university hospital, Santariskiu Clinic | Vilnius | Lithuania |
| Ampha Den Bosch / Regio Brabant | 's-Hertogenbosch | 5233 VG | Netherlands |
| Ampha De Bilt | De Bilt | 3731 DN | Netherlands |
| Ampha | Hengelo | Netherlands |
| AMPHA Nijmegen | Nijmegen | 6525EC | Netherlands |
| Centrum imunologie a alergologie s.r.o | Bratislava | Slovakia |
| Amb. klinickey imunologie a allergologie UTaRCH | Poprad | Slovakia |
| Ambulancia klinickej imunologie a alergologie | Trenčín | Slovakia |
| Medcentrum s.r.o. | Žilina | Slovakia |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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