Randomized controlled trials define shape of dose response for Pollinex Quattro Birch allergoid immunotherapy.

ABSTRACT:

Background

The Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A (POLLINEX^® Quattro Plus 1.0 ml Birch 100%) is an effective, well-tolerated short course subcutaneous immunotherapy. We performed 2 phase II studies to determine its optimal cumulative dose.

Methods

The studies were conducted in Germany, Austria and Poland (EudraCT numbers: 2012-004336-28 PQBirch203 and 2015-000984-15 PQBirch204) using a wide range of cumulative doses. In both studies, subjects were administered 6 therapy injections weekly outside the pollen season. Conjunctival Provocation Tests were performed at screening, baseline and 3-4 weeks after completing treatment, to quantify the reduction in Total Symptom Scores (as the primary endpoint) with each cumulative dose. Multiple Compar

SUBMITTER: Worm M 

PROVIDER: S-EPMC6175210 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature