Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00310466
First received: April 2, 2006
Last updated: April 29, 2013
Last verified: April 2013
History of Changes

April 2, 2006
April 29, 2013
June 2005
August 2006   (final data collection date for primary outcome measure)
  • Daily Rhinoconjunctivitis Symptom Score [ Time Frame: Birch pollen season 2006 ] [ Designated as safety issue: No ]
    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.
  • Daily Rhinoconjunctivitis Rescue Medication Score [ Time Frame: Birch pollen season 2006 ] [ Designated as safety issue: No ]
    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).
Recording of allergy symptoms and medication
Complete list of historical versions of study NCT00310466 on ClinicalTrials.gov Archive Site
  • Global Improvement of Rhinoconjunctivitis Symptoms Assessed by the Subjects [ Time Frame: Birch pollen season 2006 ] [ Designated as safety issue: No ]
    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).
  • Adverse Events [ Time Frame: Birch pollen season 2006 ] [ Designated as safety issue: Yes ]
    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).
Quality of Life and adverse events
Not Provided
Not Provided
 
Efficacy and Safety Trial of SLITone(TM) Birch in Subjects With Hayfever
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

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

Daily rhinoconjunctivits symptom and medication scores from patient diaries, adverse events
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergy
  • Biological: Sublingual immunotherapy
    once daily intake of sublingual drops
    Other Name: SLITone(TM) Birch
  • Biological: Placebo
    once daily intake of sublingual drops
  • Active Comparator: Sublingual immunotherapy
    sublingual immunotherapy with drops applied once daily by single dose containers (200 STU per dose)
    Intervention: Biological: Sublingual immunotherapy
  • Placebo Comparator: Placebo
    placebo sublingual drops
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
226
January 2007
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00310466
SHX0712
No
ALK-Abelló A/S
ALK-Abelló A/S
Not Provided
Study Director: Hendrik Wolf, PhD ALK-SCHERAX Arzneimittel GmbH
Principal Investigator: Margitta Worm, MD, Prof. Charité, Berlin
ALK-Abelló A/S
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP