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Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01191359
First Posted: August 30, 2010
Last Update Posted: February 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
ALK-Abelló A/S
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    specific antibody determination


Secondary Outcome Measures:
  • Comparison of the two administration routes with regard to safety aspects [ Time Frame: 36 weeks ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01191359     History of Changes
Other Study ID Numbers: SP-B-02
First Submitted: August 27, 2010
First Posted: August 30, 2010
Last Update Posted: February 8, 2013
Last Verified: February 2013