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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00310466
Recruitment Status : Completed
First Posted : April 4, 2006
Results First Posted : August 6, 2009
Last Update Posted : May 14, 2013
Information provided by (Responsible Party):
ALK-Abelló A/S

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

Condition or disease Intervention/treatment Phase
Allergy Biological: Sublingual immunotherapy Biological: Placebo Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentre, Randomised, Double-blind, Placebo-controlled Parallel Group Clinical Trial to Investigate the Efficacy and Safety of Specific Sublingual Immunotherapy With SLITone Birch in Patients With Seasonal Birch Pollen Induced Rhinoconjunctivitis
Study Start Date : June 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : January 2007

Arm Intervention/treatment
Active Comparator: Sublingual immunotherapy
sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)
Biological: Sublingual immunotherapy
once daily intake of sublingual drops
Other Name: SLITone(TM) Birch
Placebo Comparator: Placebo
placebo sublingual drops
Biological: Placebo
once daily intake of sublingual drops

Primary Outcome Measures :
  1. Daily Rhinoconjunctivitis Symptom Score [ Time Frame: Birch pollen season 2006 ]
    A total of 6 rhinoconjunctivitis symptoms are recorded (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, watery eyes). Each symptoms is scored on a scale from 0-3 (no symptoms-severe symptoms). I.e. the total daily score can be 0-18.

  2. Daily Rhinoconjunctivitis Rescue Medication Score [ Time Frame: Birch pollen season 2006 ]
    Rescue medication (desloratadine tablets, budesonide nasal spray, prednisone tablets) used for treatment of rhinoconjunctivitis symptoms not controlled by the study medication, were recorded. The total daily score was 0-30 (No medication-Maximum use of medication).

Secondary Outcome Measures :
  1. Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects [ Time Frame: Birch pollen season 2006 ]
    The number of participants who reported improved overall symptoms compared to the previous birch pollen season (each patient was asked to compare his/her symptoms in the 2006 birch pollen season with the symptoms in the 2005 birch pollen season).

  2. Adverse Events [ Time Frame: Birch pollen season 2006 ]
    An adverse event was defined as: Any untoward medical occurence in a patient or clinical trial subject administered a trial product and which does not necessarily have a causal relationship with this treatment (International Conference of Harmonisation (ICH) Harmonised Tripartite Guideline E2A, Step 5).

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00310466

Charité Klinik für Dermatologie, Venerologie und Allergologie
Berlin, Germany, D-10117
Sponsors and Collaborators
ALK-Abelló A/S
Study Director: Hendrik Wolf, PhD ALK-SCHERAX Arzneimittel GmbH
Principal Investigator: Margitta Worm, MD, Prof. Charite University, Berlin, Germany

Responsible Party: ALK-Abelló A/S Identifier: NCT00310466     History of Changes
Other Study ID Numbers: SHX0712
First Posted: April 4, 2006    Key Record Dates
Results First Posted: August 6, 2009
Last Update Posted: May 14, 2013
Last Verified: April 2013