Title

Efficacy and Safety of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
Double-Blind Placebo-Controlled Study of Subcutaneous Immunotherapy in Birch Pollen Allergic Patients
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Terminated
  • Study Participants

    160
To compare versus placebo the efficacy and safety of recombinant Bet v1, natural purified Bet v1 and birch pollen licenced extract used for subcutaneous immunotherapy.
Study Started
Nov 30
2002
Study Completion
Nov 30
2005
Last Update
Dec 19
2006
Estimate

Biological Subcutaneous immunotherapy - Recombinant birch pollen

Criteria

Inclusion Criteria:

Patients aged 18-50 with seasonal rhinoconjunctivitis for at least 2 years, and/or mild asthma range 1 and 2 GINA.
Positive history of birch pollen allergy (clinical history, positive skin prick test, birch specific IgE, presence of birch pollen)
Compliant patients
Written consent.

Exclusion Criteria:

Perennial rhinoconjunctivitis and/or asthma due to cosensitization with: animal danders, mites, alternaria cladosporium
Uncontrolled seasonal asthma : severe asthma permanent or not range 3 and 4 of GINA.
Patients treated with beta-blockers or under continuous oral corticosteroids.
Pregnant women
No Results Posted