Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

This study has been completed.
Information provided by (Responsible Party):
ALK-Abelló A/S Identifier:
First received: August 27, 2010
Last updated: February 7, 2013
Last verified: February 2013

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

Condition Intervention Phase
Biological: oral immunotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch [ Time Frame: after 4, 8, 12, 24, 36 weeks of treatment ] [ Designated as safety issue: No ]
    specific antibody determination

Secondary Outcome Measures:
  • Comparison of the two administration routes with regard to safety aspects [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
    adverse events

Enrollment: 66
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: sublingual administration
oral immunotherapy with drops applied once daily by single dose containers (200 STU per dose)
Biological: oral immunotherapy
orally applied specific immunotherapy
Other Name: SLITone birch
Active Comparator: vestibular administration
oral immunotherapy with drops applied by single dose containers (200 STU per dose)
Biological: oral immunotherapy
orally applied specific immunotherapy
Other Name: SLITone birch


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01191359

Universitätsklinik Bonn, Dermatology
Bonn, Germany, D-53127
Sponsors and Collaborators
ALK-Abelló A/S
Principal Investigator: Thomas Bieber, MD, PhD Universitäsklinik Bonn, Dermatology
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S Identifier: NCT01191359     History of Changes
Other Study ID Numbers: SP-B-02
Study First Received: August 27, 2010
Last Updated: February 7, 2013
Health Authority: Germany: Paul-Ehrlich-Institut processed this record on March 03, 2015