A Trial of the ALK Grass Tablet in Subjects With Hayfever
NCT ID: NCT00227279
Last Updated: 2013-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
634 participants
INTERVENTIONAL
2004-10-31
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
ALK Grass tablet
Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
2
ALK Grass tablet
Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
Interventions
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ALK Grass tablet
Tablets, 75,000 SQ-T or matching placebo. Daily administration for 3 years
Eligibility Criteria
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Inclusion Criteria
* A history of grass pollen induced rhinoconjunctivitis
* Positive skin prick test to grass
* Positive specific IgE to grass
18 Years
65 Years
ALL
No
Sponsors
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ALK-Abelló A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Bente Tholstrup, MSc
Role: STUDY_DIRECTOR
ALK-Abello A/S
Locations
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Lungemedicinsk Forskningsafdeling, Aarhus Kommunehospital
Aarhus C, , Denmark
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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GT-08
Identifier Type: -
Identifier Source: org_study_id
NCT00146991
Identifier Type: -
Identifier Source: nct_alias
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