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Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients

Sponsor
ALK-Abelló A/S (Industry)
Overall Status
Completed
CT.gov ID
NCT00857779
Collaborator
(none)
473
Enrollment
1
Location
2
Arms
8
Duration (Months)
59.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to test the pharmacodynamic equivalence with respect to IgE-blocking factor and to compare the tolerability of two different updosing schedules with ALK-Flex SQ

Condition or Disease Intervention/Treatment Phase
  • Biological: subcutaneous immunotherapy
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
473 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ
Study Start Date :
Feb 1, 2009
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Oct 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: subcutaneous immunotherapy

subcutaneous immunotherapy using a slow updosing schedule

Biological: subcutaneous immunotherapy
7 injections
Other Names:
  • AVANZ

    		•
    Active Comparator: subcutaneous injections

    subcutaneous immunotherapy using a fast updosing schedule

    Biological: subcutaneous immunotherapy
    7 injections
    Other Names:
  • AVANZ

    		•

    Outcome Measures

    Primary Outcome Measures

    1. IgE-blocking factor [start of treatment and 1 week after end of treatment]

    Secondary Outcome Measures

    1. Tolerability of two different updosing schedules [throughout treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • A clinical history of grass pollen induced allergic rhinoconjunctivitis of two years or more requiring treatment during the grass pollen season

    • Lack of adequate relief with symptomatic medication during the previous grass pollen season

    • Positive Skin Prick Test (SPT) response to Phleum pratense (wheal diameter >= 3mm) currently performed or not older than 60 days before screening

    Exclusion Criteria:

    • FEV1 < 70% of predicted value at screening

    • Bronchial asthma corresponding to GINA step 3 or more, even if controlled

    • History of asthma exacerbation or emergency visit or admission for asthma in the previous 12 months

    • Previous treatment by immunotherapy with grass pollen allergen or any other allergen within the previous 5 years

    • Exclusion criteria in accordance with contraindications in the SPC of ALK-Flex SQ

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Allergists' practice Dr. Kirsten Jung Erfurt Thueringen Germany D-99084

    Sponsors and Collaborators

    • ALK-Abelló A/S

    Investigators

    • Principal Investigator: Kirsten Jung, MD, Private practice, Erfurt, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ALK-Abelló A/S
    ClinicalTrials.gov Identifier:
    NCT00857779
    Other Study ID Numbers:
    • AF-H-01
    First Posted:
    Mar 9, 2009
    Last Update Posted:
    Feb 8, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by ALK-Abelló A/S
    allergen immunotherapy
    allergy to grass pollen
    Additional relevant MeSH terms:
    Rhinitis
    Conjunctivitis

    Study Results

    No Results Posted as of Feb 8, 2013