NCT00367640

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

Randomised,Double-blind,Placebo-controlled,Multinational,Multi-centre,Phase IIb/III Study of the Efficacy and Safety of Three Doses of Sublingual Immunotherapy (SLIT) Administered as Tablets Once Daily to Patients Suffering From Grass Pollen Rhinoconjunctivitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 628 (actual)
• Sponsor: Stallergenes Greer · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Allergy

Interventions

Type	Name	Description
DRUG	100 IR grass pollen allergen extract tablet	One sublingual tablet daily during 4 months before pollen season and during pollen season
DRUG	300 IR grass pollen allergen extract tablet	One sublingual tablet daily during 4 months before pollen season and during pollen season
DRUG	500 IR grass pollen allergen extract tablet	One sublingual tablet daily during 4 months before pollen season and during pollen season
DRUG	Placebo tablet	One sublingual tablet daily during 4 months before pollen season and during pollen season

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2006-08-23
• Last updated: 2016-05-23
• Results posted: 2016-05-23