Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01191359
First received: August 27, 2010
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Allergy
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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01191359

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

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on April 17, 2014