Status:
COMPLETED
Efficacy and Safety of Sublingual Tablets of Grass Pollen Allergen Extract
Lead Sponsor:
Stallergenes Greer
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
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 gr...
Detailed Description
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 expo...
Eligibility Criteria
Inclusion
- Male or female outpatients 18-50 years old
- grass pollen rhinoconjunctivitis of at least 2 years.
- positive specific skin prick test and a specific IgE dosage level of at least 0.70 kU/L at screening.
- written consent
- a positive response to the baseline challenge test (RTSS reaches 7 at one time-point at least during baseline challenge)
Exclusion
- Allergic rhino-conjunctivitis due to a co-sensitisation, likely to significantly change the symptoms of the subject throughout the study
- Asthma requiring treatment other than short-acting beta-2 inhaled agonists.
- Desensitisation treatment for grass pollen in the previous five years and current immunotherapy with another allergen.
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT00619827
Start Date
September 1 2007
End Date
March 1 2008
Last Update
May 23 2016
Active Locations (1)
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1
Allergy Center Vienna West, Vienna Challenge Chamber -
Vienna, Austria, 1150