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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT00857779
First received: March 5, 2009
Last updated: February 7, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Endpoint Classification: Pharmacodynamics Study
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Pinkeye
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tolerability of two different updosing schedules [ Time Frame: throughout treatment ] [ Designated as safety issue: Yes ]

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857779

Locations
Germany
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
  More Information

Publications:

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT00857779     History of Changes
Other Study ID Numbers: AF-H-01
Study First Received: March 5, 2009
Last Updated: February 7, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Asthma
Conjunctivitis
Rhinitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013