SUBLIVAC FIX Birch Dose Tolerability/Dose Range Finding

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.

Timeline

Start

2012-07

Primary completion

2013-03

Completion

2013-04

Publications

• Pfaar O, van Twuijver E, Boot JD, Opstelten DJ, Klimek L, van Ree R, Diamant Z, Kuna P, Panzner P. A randomized DBPC trial to determine the optimal effective and safe dose of a SLIT-birch pollen extract for the treatment of allergic rhinitis: results of a phase II study. Allergy. 2016 Jan;71(1):99-107. doi: 10.1111/all.12760. Epub 2015 Oct 26.

Drugs

Indications