Skip to main content
OpenTrials
Completed

NCT Number: NCT01191359

Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergy Hypersensitivity Immune System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinik Bonn, Dermatology

Bonn, D-53127, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • A history of Birch pollen allergy
  • Positive skin prick test to birch
  • Positive specific IgE to birch

Exclusion criteria

  • Uncontrolled or severe asthma (FEV1<70% of predicted value in spite of adequate pharmacologic treatment)
  • Previous treatment by immunotherapy with birch or a cross-reactingtree pollen allergen within the previous 5 years
  • Concomitant SLIT with any allergen

Treatment and study plan

oral immunotherapy

Biological

orally applied specific immunotherapy

Other names: SLITone birch

Primary outcomes

  1. Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch

    Time frame: after 4, 8, 12, 24, 36 weeks of treatment

    specific antibody determination

Secondary outcomes

  1. Comparison of the two administration routes with regard to safety aspects

    Time frame: 36 weeks

    adverse events

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

A Multicentre Randomised Phase II Clinical Pilot Study to Compare the Pharmacodynamic Efficacy and Tolerability of the Sublingual and the Vestibular Administration Route for SLITonePLUS® Birch

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 30, 2010
Registry last updated
Feb 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.