NCT01639768

SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

A Randomized, Double-blind, Placebo-controlled Study to Determine Safety, Tolerability and the Optimal Effective Dose of SUBLIVAC FIX Birch in Patients With Allergic Rhinitis/Rhinoconjunctivitis Caused by Birch Pollen

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: HAL Allergy · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to determine the optimal effective dose of SUBLIVAC FIX Birch based on reduction of upper airways reactivity after 5 months of treatment with different dosages of SUBLIVAC FIX Birch compared to placebo. Furthermore, safety and tolerability will be assessed by the number of related Adverse Events of different dosages of SUBLIVAC FIX Birch compared to placebo.

Conditions

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis

Interventions

Type	Name	Description
DRUG	SUBLIVAC FIX Birch	Comparison of different dosages to placebo

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-03-01
• Completion: 2013-04-01
• First posted: 2012-07-13
• Last updated: 2013-05-29

Locations

20 sites across 3 countries: Czechia, Germany, Poland