Efficacy and Safety of 300 IR Sublingual Immunotherapy (SLIT) Tablets in Children Suffering From Grass Pollen Rhinoconjunctivitis

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Stallergenes; Stallergenes Greer

Criteria

Inclusion Criteria:

• 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 Criteria:

• Patients who have received any desensitisation treatment for grass pollen.