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| Tracking Information | |||||
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| First Received Date ICMJE | September 7, 2005 | ||||
| Last Updated Date | September 7, 2005 | ||||
| Start Date ICMJE | January 2002 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
Double blind placebo controlled evaluation of the immunological effects of SLIT on the nasal mucosal tissue of adult humans with sever | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Sublingual Immunotherapy on Grasspollen Allergy | ||||
| Official Title ICMJE | A Placebo Controlled, Double-Blind, Randomised Study to Assess Efficacy of Sublingual Immunotherapy in Patients With Grass Pollen Allergy Through Assessment of Its Immunological Effects on the Mucosal Tissue of the Nose. | ||||
| Brief Summary | The objective of the study is to document the objective immunological effects of SLIT on the nasal mucosa. Better understanding of these immunological pathways, in which this widely practised clinical therapy is likely to work, can only benefit the overall outcome of this, more patient friendly, therapy and it will demonstrate the effects of SLIT on the allergic reaction, with objective parameters, in the nasal tissues showing it to be a true etiological treatment of allergy. |
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| Detailed Description | Double blind placebo controlled evaluation of the immunological effects (decrease of IgE specific cells and the decrease of Th2 mediator release, respectively increase of Th1 mediator release) of SLIT on the nasal mucosal tissue of adult humans with severe rhinocunjunctivitis due to grass pollen allergy. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Condition ICMJE | Hayfever | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 38 | ||||
| Completion Date | December 2006 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00150514 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | AB0103 | ||||
| Study Sponsor ICMJE | Radboud University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Radboud University | ||||
| Verification Date | November 2003 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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