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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
History of Changes
August 27, 2010
February 7, 2013
January 2010
January 2011   (Final data collection date for primary outcome measure)
Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch [ Time Frame: after 4, 8, 12, 24, 36 weeks of treatment ]
specific antibody determination
Pharmacodynamic efficacy of two different administration routes of SLITonePLUS Birch
Complete list of historical versions of study NCT01191359 on ClinicalTrials.gov Archive Site
Comparison of the two administration routes with regard to safety aspects [ Time Frame: 36 weeks ]
adverse events
Comparison of the two administration routes with regard to safety aspects
Not Provided
Not Provided
 
Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch
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
Multicentre Phase II trial, comparing two different administration routes of SLITonePLUS Birch in regard to pharmacodynamic efficacy and tolerability.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Allergy
Biological: oral immunotherapy
orally applied specific immunotherapy
Other Name: SLITone birch
  • Active Comparator: sublingual administration
    oral immunotherapy with drops applied once daily by single dose containers (200 STU per dose)
    Intervention: Biological: oral immunotherapy
  • Active Comparator: vestibular administration
    oral immunotherapy with drops applied by single dose containers (200 STU per dose)
    Intervention: Biological: oral immunotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
January 2011
January 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01191359
SP-B-02
No
Not Provided
Not Provided
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Principal Investigator: Thomas Bieber, MD, PhD Universitäsklinik Bonn, Dermatology
ALK-Abelló A/S
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP