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Sponsored by: |
Stallergenes |
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Information provided by: | Stallergenes |
ClinicalTrials.gov Identifier: | NCT00619827 |
The objective of this study is to assess the effect of grass pollen extract SLIT tablets on the Rhinoconjunctivitis Total Symptom Score (RTSS) of the six rhinoconjunctivitis symptoms in response to grass pollen challenge after one week, one, two and four months of treatment in patients suffering from Seasonal Allergic Rhinoconjunctivitis (SAR) due to grass pollen.
Condition | Intervention | Phase |
---|---|---|
Seasonal Allergic Rhinitis |
Biological: Sublingual immunotherapy tablets of grass pollen allergen extract |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | A Randomised, Double-Blind, in Parallel Groups Placebo-Controlled, Mono-Centre, Phase I Study to Assess After Allergen Challenge in an Allergen Exposition Chamber the Effect and Its Time Course of Sublingual Immunotherapy (SLIT) Administered as 300IR Allergen-Based Tablets Once Daily to Adults Suffering From Grass Pollen Rhinoconjunctivitis |
Enrollment: | 89 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Placebo Comparator |
Biological: Sublingual immunotherapy tablets of grass pollen allergen extract
300IR allergen-based tablets once daily during four months
|
2: Experimental
Sublingual tablet of grass pollen allergen extract in dose of 300 IR once daily
|
Biological: Sublingual immunotherapy tablets of grass pollen allergen extract
300IR allergen-based tablets once daily during four months
|
The purpose of this study is to determine whether SLIT tablets are effective on symptoms of allergic rhinitis compared to placebo in patients suffering from allergic rhinitis to grass pollen when exposed in an allergen chamber and also to determine the onset of action of SLIT tablets on allergic rhinitis symptoms.
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Austria | |
Allergy Center Vienna West, Vienna Challenge Chamber - | |
VIENNA, Austria, 1150 |
Principal Investigator: | Friedrich HORAK, Pr. MD | Allergy Center Vienna West, VIENNE, AUSTRIA |
Responsible Party: | Stallergènes S.A. ( Olivier de Beaumont, Medical Director ) |
Study ID Numbers: | VO56.07 A |
Study First Received: | February 8, 2008 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00619827 |
Health Authority: | Austria: Federal Office for Safety in Health Care |
Allergy Rhinitis Conjuntivitis Allergen challenge |
Allergen exposition chamber ALLERGY HYPERSENSITIVITY |
Hypersensitivity Otorhinolaryngologic Diseases Respiratory Tract Infections Respiratory Tract Diseases |
Rhinitis, Allergic, Seasonal Hypersensitivity, Immediate Rhinitis Respiratory Hypersensitivity |
Immune System Diseases Nose Diseases |