Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis
NCT ID: NCT00367640
Last Updated: 2016-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
628 participants
INTERVENTIONAL
2004-11-30
2005-09-30
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
QUADRUPLE
Study Groups
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100 IR
100 IR grass pollen allergen extract tablet
100 IR grass pollen allergen extract tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
300 IR
300 IR grass pollen allergen extract tablet
300 IR grass pollen allergen extract tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
500 IR
500 IR grass pollen allergen extract tablet
500 IR grass pollen allergen extract tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Placebo
Placebo tablet
Placebo tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Interventions
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100 IR grass pollen allergen extract tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
300 IR grass pollen allergen extract tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
500 IR grass pollen allergen extract tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Placebo tablet
One sublingual tablet daily during 4 months before pollen season and during pollen season
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
* Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
* Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
* Safety laboratory resuts within the references ranges
Exclusion Criteria
* Had received desensitisation treatment for grass pollen
* Treatment by immunotherapy with another allergen within the previous 5 years
* Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
* Treated with beta-blockers or under continuous corticotherapy
18 Years
45 Years
ALL
No
Sponsors
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Stallergenes Greer
INDUSTRY
Responsible Party
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Principal Investigators
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Alain DIDIER, Professor
Role: PRINCIPAL_INVESTIGATOR
Hôpital Rangueil-Larrey, Toulouse, France
References
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Didier A, Malling HJ, Worm M, Horak F, Jager S, Montagut A, Andre C, de Beaumont O, Melac M. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol. 2007 Dec;120(6):1338-45. doi: 10.1016/j.jaci.2007.07.046. Epub 2007 Nov 1.
Other Identifiers
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VO34.04
Identifier Type: -
Identifier Source: org_study_id
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