- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01889875
Immunological Comparison of AIT and SCIT Immunotherapy Against Grass Pollen
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Worldwide, more than 400 million people have allergic rhinitis, and sick-leave due to this condition costs societies billions of dollars annually1. Allergic rhinitis is most commonly treated with oral antihistamines and intranasal corticosteroids2. For moderate-severe rhinitis with poor control on topical treatment, immunotherapy should be considered3. Allergen immunotherapy is the only disease-modifying treatment available for IgE mediated allergy.
Immunotherapy is most commonly administered with subcutaneous injections of SQ-standardized allergen extracts (SCIT) and to a lesser extent, as sublingual drops (SLIT). However, other options now exist with the newly developed sublingual allergen immunotherapy tablets (AIT). The clinical effect of AIT4 and SCIT5 against grass pollen allergy has been demonstrated in large double-blind-placebo-controlled registration trials. These studies report significant reductions of symptom scores (AIT 30%, SCIT 32%) and seasonal rescue medication scores (AIT 38%, SCIT 41%) when compared with placebo4,5, persisting several years after withdrawal4,6. Immunotherapy may prevent new sensitizations and progression of rhinitis to asthma7-11. Allergen immunotherapy is generally well tolerated with few side effects, although a potential risk of anaphylactic reactions exists 12. A review of recent parallel meta-analyses on immunotherapy for grass pollen rhinitis suggests that the safety profile of AIT is superior to that of SCIT13.
The recommended length of immunotherapy with both SCIT and AIT is 3-5 years2, although the route of administration and the doses of allergen differ substantially. SCIT involves an up-dosing phase lasting 12-15 weeks with one or more weekly injections of increasing doses of allergen followed by a maintenance dose every 6-10 weeks. AIT starts with the daily maintenance dose, resulting in high cumulative doses. It is largely unknown whether the immunological mechanisms involved in the clinical effect are the same.
The changes in immunology have been extensively investigated for SCIT, and the most pronounced patterns are: 1) the induction of blocking antibodies, 2) a shift in Th1/Th2 balance towards Th1, and 3) induction of regulatory T cells. Similar mechanisms seem to be in play for AIT 14-16. Increases in allergen-specific non-IgE antibodies have been demonstrated in large trials of both SCIT and AIT treatment17,18, and studies have demonstrated that serum antibodies can reduce in vitro reactions mimicking allergic responses, such as IgE binding to allergen, IgE facilitated antigen presentation and basophil activation19-22, suggesting that both humoral and cellular effects play a role23.
The aim of the present study was to compare the effect of AIT and SCIT on antibody titers (IgE and IgG4), on allergen-IgE interaction in competition assays (IgE-blocking factor and FAP inhibition) and on effector cell activation (BAT). Nasal challenges were included to assess the changes in nasal response to grass pollen allergen.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Copenhagen NV, Denmark, 2400
- Bispebjerg University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
|
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Active Comparator: Subcutaneous Immunotherapy (SCIT)
Treatment using ALK AluTard 225 "Phleum pratense"
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Active Comparator: Sublingual Allergen Immunotherapy Tablets (AIT)
Treatment using ALK Grazax 75,000 SQ-T "Phleum pratense"
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes over time in specific Antibodies
Time Frame: 0, 1, 2, 3, 6, 7, 10, 12, and 15 months post treatment start
|
IgE, IgG4
|
0, 1, 2, 3, 6, 7, 10, 12, and 15 months post treatment start
|
Changes over time in Basophil Activation Test
Time Frame: 0, 1, 3, 6, 7, 10, 12, and 15 months post treatment start
|
0, 1, 3, 6, 7, 10, 12, and 15 months post treatment start
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes over time in Nasal Challenge symptoms
Time Frame: 0, 3, 10, and 15 months post treatment start
|
0, 3, 10, and 15 months post treatment start
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Graesallergi
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Allergic Rhinitis Due to Grass Pollens
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Stallergenes GreerCompletedAllergic Rhinitis Due to Grass PollensUnited States
-
ALK-Abelló A/SCompletedAllergic Rhinitis Due to Grass PollensSpain
-
Mahidol UniversityNational Research Council of ThailandCompletedAllergy to Grass Pollen | Allergic Rhinitis Due to Weed PollensThailand
-
Stallergenes GreerRegistrat-MapiTerminatedAllergic Rhinitis Due to Grass PollensFrance
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AOBiome LLCIntegrium; Orange County Research CenterCompletedAllergic Rhinitis Due to Grass Pollen | Allergic Rhinitis | Healthy VolunteersUnited States, Canada
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Medical University of ViennaAstraZenecaCompletedAllergic Rhinitis Due to Grass Pollen | Allergic AsthmaAustria
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Lars Olaf CardellRecruitingAllergic Rhinitis Due to Grass PollenSweden
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AlyatecCompletedAllergic Rhinitis Due to Grass PollenFrance
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Lars Olaf CardellCompletedAllergic Rhinitis Due to Grass PollenSweden
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Medical University of LublinCompletedAllergic Rhinitis Due to Grass PollenPoland
Clinical Trials on ALK AluTard 225 "Phleum pratense"
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Aarhus University HospitalUniversity of Aarhus; ALK-Abelló A/S; Lundbeck FoundationCompleted
-
Aarhus University HospitalUniversity of Aarhus; University Hospital, LinkoepingActive, not recruitingAllergic Rhinitis Due to Grass Pollen | Allergic Asthma | Allergic Conjunctivitis of Both EyesDenmark, Sweden
-
University of AarhusCompletedAllergy | Immune Tolerance | Injection Site DiscomfortDenmark
-
Imperial College LondonALK-Abelló A/SUnknownRhinitis, Allergic, SeasonalUnited Kingdom
-
Karolinska InstitutetKarolinska University Hospital; Skane University HospitalCompletedAllergic RhinitisSweden
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Rigshospitalet, DenmarkTRYG FoundationCompleted
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Karolinska InstitutetCompleted
-
Imperial College LondonALK-Abelló A/SCompletedRhinitis, Allergic, SeasonalUnited Kingdom
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Karolinska InstitutetKarolinska University Hospital; Skane University Hospital; Sodra Alvsborgs HospitalCompletedRhinitis, AllergicSweden
-
ALK-Abelló A/SErgomed; ACM Pivotal Global Central Laboratory; Brecon Pharmaceuticals LtdCompletedRhino-conjunctivitisPoland