Back to resultsComparison of Different Up-dosing Schedules With Osiris
Primary Purpose
Allergic Rhinitis
Status
Terminated
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
OSIRIS
OSIRIS other concentration 1
OSIRIS other concentration 2
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Rhinitis, Allergic, Immunotherapy
Eligibility Criteria
Inclusion Criteria:
- history of grass pollen allergy
- Positive SPT to grass
- Positive IgE to grass
Exclusion Criteria:
- uncontrolled and severe asthma
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
OSIRIS
OSIRIS other concentration 1
OSIRIS other concentration 2
Arm Description
Outcomes
Primary Outcome Measures
evaluate the tolerability of different up-dosing schedules
Secondary Outcome Measures
patient's satisfaction
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01240954
Brief Title
Comparison of Different Up-dosing Schedules With Osiris
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Terminated
Why Stopped
CA approval not obtained
Study Start Date
December 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare different up-dosing schedules with Osiris.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Rhinitis, Allergic, Immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
210 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OSIRIS
Arm Type
Active Comparator
Arm Title
OSIRIS other concentration 1
Arm Type
Experimental
Arm Title
OSIRIS other concentration 2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OSIRIS
Intervention Description
OSIRIS current practice
Intervention Type
Drug
Intervention Name(s)
OSIRIS other concentration 1
Intervention Description
OSIRIS new concentration 1
Intervention Type
Drug
Intervention Name(s)
OSIRIS other concentration 2
Intervention Description
OSIRIS new concentration 2
Primary Outcome Measure Information:
Title
evaluate the tolerability of different up-dosing schedules
Time Frame
30 days
Secondary Outcome Measure Information:
Title
patient's satisfaction
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
history of grass pollen allergy
Positive SPT to grass
Positive IgE to grass
Exclusion Criteria:
uncontrolled and severe asthma
Facility Information:
City
Kraków
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Comparison of Different Up-dosing Schedules With Osiris
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