Status:

COMPLETED

Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever

Lead Sponsor:

ALK-Abelló A/S

Conditions:

Allergy

Eligibility:

All Genders

18-65 years

Phase:

PHASE3

Brief Summary

The trial is performed to assess the efficacy and safety of SLIT One birch for treatment of birch pollen induced allergy

Detailed Description

Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events

Eligibility Criteria

Inclusion

  • A history of birch pollen allergy
  • Positive skin prick test to birch
  • Positive conjunctival test to birch
  • Positive specific Immunoglobulin E (IgE) to birch

Exclusion

  • Forced expiratory volume in 1 second (FEV1)\<70% of predicted value
  • History of seasonal allergy interfering with study
  • History of symptomatic perennial allergy
  • History of emergency visit or admission for asthma in the previous 12 month

Key Trial Info

Start Date :

June 1 2005

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2007

Estimated Enrollment :

226 Patients enrolled

Trial Details

Trial ID

NCT00310466

Start Date

June 1 2005

End Date

January 1 2007

Last Update

May 14 2013

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Charité Klinik für Dermatologie, Venerologie und Allergologie

Berlin, State of Berlin, Germany, D-10117