Status:

COMPLETED

Efficacy and Tolerability of Two Different Administration Routes With SLITonePLUS Birch

Lead Sponsor:

ALK-Abelló A/S

Conditions:

Allergy

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 1 2011

    Estimated Enrollment :

    66 Patients enrolled

    Trial Details

    Trial ID

    NCT01191359

    Start Date

    January 1 2010

    End Date

    January 1 2011

    Last Update

    February 8 2013

    Active Locations (1)

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    1

    Universitätsklinik Bonn, Dermatology

    Bonn, Germany, D-53127