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

This study has been completed.
Information provided by (Responsible Party):
ALK-Abelló A/S Identifier:
First received: March 5, 2009
Last updated: February 7, 2013
Last verified: February 2013
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 Intervention Phase
Rhinitis Conjunctivitis Asthma Biological: subcutaneous immunotherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

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

Primary Outcome Measures:
  • IgE-blocking factor [ Time Frame: start of treatment and 1 week after end of treatment ]

Secondary Outcome Measures:
  • Tolerability of two different updosing schedules [ Time Frame: throughout treatment ]

Enrollment: 473
Study Start Date: February 2009
Study Completion Date: October 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: subcutaneous immunotherapy
subcutaneous immunotherapy using a slow updosing schedule
Biological: subcutaneous immunotherapy
7 injections
Other Name: AVANZ
Active Comparator: subcutaneous injections
subcutaneous immunotherapy using a fast updosing schedule
Biological: subcutaneous immunotherapy
7 injections
Other Name: AVANZ


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
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
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Please refer to this study by its identifier: NCT00857779

Allergists` practice Dr. Kirsten Jung
Erfurt, Thueringen, Germany, D-99084
Sponsors and Collaborators
ALK-Abelló A/S
Principal Investigator: Kirsten Jung, MD Private practice, Erfurt, Germany
  More Information

Responsible Party: ALK-Abelló A/S Identifier: NCT00857779     History of Changes
Other Study ID Numbers: AF-H-01
Study First Received: March 5, 2009
Last Updated: February 7, 2013

Keywords provided by ALK-Abelló A/S:
allergen immunotherapy
allergy to grass pollen

Additional relevant MeSH terms:
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Conjunctival Diseases
Eye Diseases processed this record on June 23, 2017