Status:
COMPLETED
Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis
Lead Sponsor:
Stallergenes Greer
Conditions:
Allergy
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
A phase III study to evaluate the efficacy and safety of SLIT for grass pollen allergens compared with placebo for reduction of symptoms and rescue medication usage in children.
Eligibility Criteria
Inclusion
- Male or female outpatients aged 5 to 17 years.
- Written consent / assent.
- Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons.
- Sensitised to grass pollen (positive SPT and grass pollen-specific IgE values of at least Class 2).
- Total symptom score on the Retrospective RTSS during the previous pollen season of greater than or equal to 12.
Exclusion
- Patients who have received any desensitisation treatment for grass pollen.
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
278 Patients enrolled
Trial Details
Trial ID
NCT00409409
Start Date
December 1 2006
End Date
September 1 2007
Last Update
May 26 2016
Active Locations (1)
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1
Charité - Campus Virchow Klinikum
Berlin, Germany