NCT00422149

Twin SUBLIVAC® Grasses Clinical Efficacy Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: HAL Allergy · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.

Detailed description

Indication under study: IgE mediated allergic disorders triggered by grass pollen. Number of centres: approximately 50. Study period planned: Q2-2006 until Q3-2008 Analysis after one exposed season (2007); based on the outcome the study will be stopped or continued for another season. Subject selection criteria: Seasonal rhinitis and/or rhinoconjunctivitis with or without mild asthma (FEV1 \> 70%) related to grass pollen, age 12 years or older. Dosage schedule: Start with two drops daily of SUBLIVAC® and increase by two drops daily, until the maintenance dose of 10 drops SUBLIVAC® GrassesSUBLIVAC® Grasses is reached. Route of administration: Sublingual application (drops are to be held underneath the tongue for 2-3 minutes and then will be swallowed). Duration of treatment: 6 to 12 months blinded per subject . Efficacy parameters

Conditions

• Rhinitis, Allergic, Seasonal
• Conjunctivitis, Allergic

Interventions

Type	Name	Description
DRUG	SUBLIVAC® Grasses/Placebo treatment	SUBLIVAC® Grasses/Placebo treatment
DRUG	SUBLIVAC® Grasses treatment	SUBLIVAC® Grasses treatment
DRUG	Placebo treatment	Placebo treatment

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-10-01
• Completion: 2007-10-01
• First posted: 2007-01-15
• Last updated: 2012-02-07

Locations

60 sites across 4 countries: Belgium, Germany, Netherlands, Poland