Status:

COMPLETED

Efficacy and Safety of Intraseasonal Specific Immunotherapy With Depiquick® Birch

Lead Sponsor:

Novartis

Conditions:

Allergic Rhinoconjunctivitis

Eligibility:

All Genders

12-70 years

Phase:

PHASE3

Brief Summary

This study will assess efficacy and safety of intraseasonal specific short-term immunotherapy with Depiquick® Birch in patients with allergic rhinitis and or rhinoconjunctivitis with or without interm...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • Patients must experience significant allergic symptoms on visit 2
  • Medical history of allergic rhinitis and/or rhinoconjunctivitis with clinically relevant sensitization to tree allergens
  • Specific IgE against birch allergens (CAP RAST ≥ 2)
  • Exclusion criteria:
  • History of significant clinical manifestations of allergy as a result of sensitization against grass or weed pollen and perennial allergens
  • FEV1 or PEF value ≤ 80 %
  • Persistent asthma (GINA ≥ 2)
  • Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2012

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    July 1 2012

    Estimated Enrollment :

    202 Patients enrolled

    Trial Details

    Trial ID

    NCT01902992

    Start Date

    March 1 2012

    End Date

    July 1 2012

    Last Update

    March 22 2017

    Active Locations (35)

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    Page 1 of 9 (35 locations)

    1

    Novartis Investigative Site

    Aachen, Germany, 52074

    2

    Novartis Investigative Site

    Aschaffenburg, Germany, 63739

    3

    Novartis Investigative Site

    Augsburg, Germany, 86179

    4

    Novartis Investigative Site

    Bad Wildbad, Germany, 75323