Immunological Comparison of AIT and SCIT Immunotherapy Against Grass Pollen
1 other identifier
interventional
40
1 country
1
Brief Summary
Treatment of pollen allergies can be roughly divided into symptomatic treatment (e.g. antihistamines, steroids) and potentially curative immunotherapy. Immunotherapy can be delivered using subcutaneous or oral (mucosal) routes, with similar clinical outcome. The study seeks to compare immunological changes during subcutaneous (SCIT) and sublingual tablet (AIT) immunotherapy of grass pollen allergy (hayfever).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2010
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
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 24, 2013
CompletedFirst Posted
Study publicly available on registry
July 1, 2013
CompletedJuly 1, 2013
June 1, 2013
1.8 years
June 24, 2013
June 26, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
Changes over time in specific Antibodies
IgE, IgG4
0, 1, 2, 3, 6, 7, 10, 12, and 15 months post treatment start
Changes over time in Basophil Activation Test
0, 1, 3, 6, 7, 10, 12, and 15 months post treatment start
Secondary Outcomes (1)
Changes over time in Nasal Challenge symptoms
0, 3, 10, and 15 months post treatment start
Study Arms (3)
Control group
NO INTERVENTIONSubcutaneous Immunotherapy (SCIT)
ACTIVE COMPARATORTreatment using ALK AluTard 225 "Phleum pratense"
Sublingual Allergen Immunotherapy Tablets (AIT)
ACTIVE COMPARATORTreatment using ALK Grazax 75,000 SQ-T "Phleum pratense"
Interventions
Eligibility Criteria
You may qualify if:
- history of rhinitis with hay fever symptoms during the grass pollen season,
- a skin-prick-test-verified grass pollen allergy (Phleum pratense),
- eligibility for immunotherapy based on ARIA guidelines
You may not qualify if:
- current long-term systemic steroid treatment,
- previous immunotherapy,
- asthma and outside-season airway hyperresponsiveness (AHR) (September 2011),
- pregnancy,
- negative RAST for grass, and
- treatment side effect
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bispebjerg Hospitallead
- ALK-Abelló A/Scollaborator
Study Sites (1)
Bispebjerg University Hospital
Copenhagen NV, Denmark, 2400, Denmark
Related Publications (1)
Aasbjerg K, Backer V, Lund G, Holm J, Nielsen NC, Holse M, Wagtmann VR, Wurtzen PA. Immunological comparison of allergen immunotherapy tablet treatment and subcutaneous immunotherapy against grass allergy. Clin Exp Allergy. 2014 Mar;44(3):417-28. doi: 10.1111/cea.12241.
PMID: 24734285DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 24, 2013
First Posted
July 1, 2013
Study Start
November 1, 2010
Primary Completion
August 1, 2012
Study Completion
August 1, 2012
Last Updated
July 1, 2013
Record last verified: 2013-06