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| Descriptive Information Fields | |||||
| Brief Title † | Effects of Sublingual Immunotherapy on Grasspollen Allergy | ||||
| Official Title † | 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 † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Double blind placebo controlled evaluation of the immunological effects of SLIT on the nasal mucosal tissue of adult humans with sever | ||||
| Secondary Outcome Measure † | I. Correlating immunological effects to a retrospective subjective complaint reduction. II. Rescue medication decrease through SLIT. III. Determining the effects of SLIT on decongestion. IV. Assessment of treatment compliance. |
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| Condition † | Hayfever | ||||
| Intervention † | Drug: Oralgen Procedure: Nasal biopsy Procedure: Nasal washing Procedure: Peak nasal inspiratory flow |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 38 | ||||
| Start Date † | January 2002 | ||||
| Completion Date | December 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | Netherlands | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00150514 | ||||
| Organization ID | AB0103 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Radboud University | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Radboud University | ||||
| Verification Date | November 2003 | ||||
| First Received Date † | September 7, 2005 | ||||
| Last Updated Date | September 7, 2005 | ||||