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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
  Purpose

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


Condition Intervention Phase
Allergy
 Biological: Sublingual immunotherapy
Biological: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Allergy
U.S. FDA Resources

Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Enrollment: 226
Study Start Date: June 2005
Study Completion Date: January 2007
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310466

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

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00310466     History of Changes
Other Study ID Numbers: SHX0712
Study First Received: April 2, 2006
Results First Received: March 12, 2009
Last Updated: April 29, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on May 19, 2013