Study on Pharmacodynamic Parameter and Tolerability With Subcutaneous Immunotherapy in Grass Pollen Allergic Patients
A Multicentre Randomised Phase II Clinical Trial to Demonstrate Equivalent Pharmacodynamic Efficacy and Tolerability of Two Updosing Schedules for ALK-Flex SQ
1 other identifier
interventional
473
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 9, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedFebruary 8, 2013
February 1, 2013
6 months
March 5, 2009
February 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
IgE-blocking factor
start of treatment and 1 week after end of treatment
Secondary Outcomes (1)
Tolerability of two different updosing schedules
throughout treatment
Study Arms (2)
subcutaneous immunotherapy
ACTIVE COMPARATORsubcutaneous immunotherapy using a slow updosing schedule
subcutaneous injections
ACTIVE COMPARATORsubcutaneous immunotherapy using a fast updosing schedule
Interventions
7 injections
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ALK-Abelló A/Slead
Study Sites (1)
Allergists' practice Dr. Kirsten Jung
Erfurt, Thuringia, D-99084, Germany
Related Publications (1)
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.
PMID: 22385366RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kirsten Jung, MD
Private practice, Erfurt, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 9, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2009
Study Completion
October 1, 2009
Last Updated
February 8, 2013
Record last verified: 2013-02