Status:
COMPLETED
Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis
Lead Sponsor:
Stallergenes Greer
Conditions:
Allergy
Eligibility:
All Genders
18-45 years
Phase:
PHASE2
PHASE3
Brief Summary
To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage
Eligibility Criteria
Inclusion
- Written consent
- Grass-pollen related allergic rhinoconjunctivitis for at least the last 2 pollen seasons.
- Sensitised to grass pollen (positive SPT and RAST level of at least class 2).
- Total symptom score of the RRTSS during the previous pollen season greater than or equal to 12.
- Safety laboratory resuts within the references ranges
Exclusion
- Pregnancy, breast-feeding/lactation
- Had received desensitisation treatment for grass pollen
- Treatment by immunotherapy with another allergen within the previous 5 years
- Usual contraindications of immunotherapy such as serious immunopathologic conditions or malignancies
- Treated with beta-blockers or under continuous corticotherapy
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT00367640
Start Date
November 1 2004
End Date
September 1 2005
Last Update
May 23 2016
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