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

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: NCT00857779
Recruitment Status : Completed
First Posted : March 9, 2009
Last Update Posted : February 8, 2013
Information provided by (Responsible Party):
ALK-Abelló A/S

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
Rhinitis Conjunctivitis Asthma Biological: subcutaneous immunotherapy Phase 2

Study Type : Interventional  (Clinical Trial)
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 : February 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : October 2009

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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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 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

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): 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

Publications of Results:
Responsible Party: ALK-Abelló A/S Identifier: NCT00857779     History of Changes
Other Study ID Numbers: AF-H-01
First Posted: March 9, 2009    Key Record Dates
Last Update Posted: February 8, 2013
Last Verified: February 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