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This trial is performed to assess the efficacy and safety of the ALK Grass tablet for treatment of grass pollen induced rhinoconjunctivitis (hayfever).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALK Grass tablet | Biological | Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recording of rhinoconjunctivitis symptoms | Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 | |
| Recording of use of rescue medication | Daily recordings during the entire grass pollen seasons 2007, 2008 and 2009 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | Weekly recordings during the entire grass pollen seasons 2007, 2008 and 2009 |
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Eligibility Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bente Tholstrup, MSc | ALK-Abello A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16890769 | Result | Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Rivas MF, Ribel M, Durham SR. Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006 Aug;118(2):434-40. doi: 10.1016/j.jaci.2006.05.003. | |
| 17620075 | Result | Durham SR, Riis B. Grass allergen tablet immunotherapy relieves individual seasonal eye and nasal symptoms, including nasal blockage. Allergy. 2007 Aug;62(8):954-7. doi: 10.1111/j.1398-9995.2007.01402.x. |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
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| 17620076 | Result | Calderon MA, Birk AO, Andersen JS, Durham SR. Prolonged preseasonal treatment phase with Grazax sublingual immunotherapy increases clinical efficacy. Allergy. 2007 Aug;62(8):958-61. doi: 10.1111/j.1398-9995.2007.01416.x. |
| 18155284 | Result | Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, Riis B, Gronager PM, Durham SR. Sublingual grass allergen tablet immunotherapy provides sustained clinical benefit with progressive immunologic changes over 2 years. J Allergy Clin Immunol. 2008 Feb;121(2):512-518.e2. doi: 10.1016/j.jaci.2007.10.039. Epub 2007 Dec 26. |
| D012140 |
| Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |