Safety and Efficacy of Sublingual Immunotherapy (SLIT) Tablets in Grass Pollen Rhinoconjunctivitis

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of SLIT compared with placebo for reduction of symptoms and rescue medication usage

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stallergenes; Stallergenes Greer
• Treatments: Immunologic Factors

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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