Allergic Rhinitis/Rhinoconjunctivitis +-Intermittent Asthma Clinical Trial
Official title:
Multicenter, Placebo-controlled, Long-term Study of Depigoid Birch 5000 in Adults and Adolescents With Allergic Rhinitis and/or Rhinoconjunctivitis With or Without Intermittent Asthma
Specific immunotherapy for IgE mediated sensitization to birch pollen. Long-term study to assess safety and efficacy of Depigoid(R)Birch 5000 - a modified pollen extract of Betula alba (Birch) - versus placebo.
Investigation of the long-term efficacy and safety of Depigoid Birch 5000 according to the
perennial treatment regimen in comparison to placebo in adult and adolescent patients with
birch pollen-induced allergic rhinitis and/or rhinoconjunctivitis to show superiority vs.
placebo.
As the study includes adolescent patients it is run under an approved PIP.
Total study duration per patient will be 5 years: 3 years of perennial treatment (application
of study medication at intervals of 4-6 weeks) followed by a treatment-free observational
phase of 2 years (seasons).
;