NCT00932607

SUBLIVAC® Birch PROBE Study

SUBLIVAC® Birch Prospective, Randomized, Open, Blinded Endpoint (PROBE) Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: HAL Allergy · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective of the study is to show, on an exploratory basis, that treatment with SUBLIVAC Birch is also effective compared to treatment with Staloral Birch by means of reduction in allergic symptoms during nasal provocation in subjects suffering from IgE mediated allergic complaints triggered by birch pollen.

Conditions

• Seasonal Rhinitis and/or Rhinoconjunctivitis
• Birch Pollen Allergy

Interventions

Type	Name	Description
DRUG	sublingual immunotherapy	Start with 1 drop daily of SUBLIVAC Birch and increase by 1 drop daily, until the maintenance dose of 5 drops is reached. This maintenance dose should then be taken daily. Or 1 puff of Staloral Birch 10 I.R./ml on day one, 2 puffs on day two and increase by 2 puffs until at day six 10 puffs are reached. At day seven 1 puff of Staloral Birch 300 I.R./ml is taken, at day eight 2 puffs and day nine 4 puffs. From then on 4 puffs daily are taken. Route of administration: Sublingual application. Drops (for SUBLIVAC Birch) or puffs (for Staloral Birch) are to be held underneath the tongue and then will be swallowed. Duration of treatment: 16-20 weeks per subject (at least 12 weeks for subjects with hazel or alder allergy).

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-02-01
• First posted: 2009-07-03
• Last updated: 2012-02-07

Locations

1 site across 1 country: Germany