Back to resultsStudy on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients
Primary Purpose
Rhinitis, Conjunctivitis, Asthma
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
subcutaneous immunotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis focused on measuring allergen immunotherapy, allergy to grass pollen
Eligibility 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
Sites / Locations
- Allergists' practice Dr. Kirsten Jung
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
subcutaneous immunotherapy
subcutaneous injections
Arm Description
subcutaneous immunotherapy using a slow updosing schedule
subcutaneous immunotherapy using a fast updosing schedule
Outcomes
Primary Outcome Measures
IgE-blocking factor
Secondary Outcome Measures
Tolerability of two different updosing schedules
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00857779
Brief Title
Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S
4. Oversight
Data Monitoring Committee
Yes
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Conjunctivitis, Asthma
Keywords
allergen immunotherapy, allergy to grass pollen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
473 (Actual)
8. Arms, Groups, and Interventions
Arm Title
subcutaneous immunotherapy
Arm Type
Active Comparator
Arm Description
subcutaneous immunotherapy using a slow updosing schedule
Arm Title
subcutaneous injections
Arm Type
Active Comparator
Arm Description
subcutaneous immunotherapy using a fast updosing schedule
Intervention Type
Biological
Intervention Name(s)
subcutaneous immunotherapy
Other Intervention Name(s)
AVANZ
Intervention Description
7 injections
Primary Outcome Measure Information:
Title
IgE-blocking factor
Time Frame
start of treatment and 1 week after end of treatment
Secondary Outcome Measure Information:
Title
Tolerability of two different updosing schedules
Time Frame
throughout treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirsten Jung, MD
Organizational Affiliation
Private practice, Erfurt, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergists' practice Dr. Kirsten Jung
City
Erfurt
State/Province
Thueringen
ZIP/Postal Code
D-99084
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22385366
Citation
Pfaar O, Jung K, Wolf H, Decot E, Kleine-Tebbe J, Klimek L, Wustenberg E. Immunological effects and tolerability of a new fast updosed immunologically enhanced subcutaneous immunotherapy formulation with optimized allergen/adjuvant ratio. Allergy. 2012 May;67(5):630-7. doi: 10.1111/j.1398-9995.2012.02801.x. Epub 2012 Mar 3.
Results Reference
result
Learn more about this trial
Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients
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