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Immunological Comparison of AIT and SCIT Immunotherapy Against Grass Pollen

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ClinicalTrials.gov Identifier: NCT01889875
Recruitment Status : Completed
First Posted : July 1, 2013
Last Update Posted : July 1, 2013
Sponsor:
Collaborator:
ALK-Abelló A/S
Information provided by (Responsible Party):
Vibeke Backer, Bispebjerg Hospital

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).

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Due to Grass Pollens Drug: ALK Grazax 75,000 SQ-T "Phleum pratense" Drug: ALK AluTard 225 "Phleum pratense" Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Immunological Comparison of AIT and SCIT Immunotherapy Against Grass Pollen
Study Start Date : November 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Active Comparator: Subcutaneous Immunotherapy (SCIT)
Treatment using ALK AluTard 225 "Phleum pratense"
Drug: ALK AluTard 225 "Phleum pratense"
Active Comparator: Sublingual Allergen Immunotherapy Tablets (AIT)
Treatment using ALK Grazax 75,000 SQ-T "Phleum pratense"
Drug: ALK Grazax 75,000 SQ-T "Phleum pratense"



Primary Outcome Measures :
  1. Changes over time in specific Antibodies [ Time Frame: 0, 1, 2, 3, 6, 7, 10, 12, and 15 months post treatment start ]
    IgE, IgG4

  2. Changes over time in Basophil Activation Test [ Time Frame: 0, 1, 3, 6, 7, 10, 12, and 15 months post treatment start ]

Secondary Outcome Measures :
  1. Changes over time in Nasal Challenge symptoms [ Time Frame: 0, 3, 10, and 15 months post treatment start ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889875


Locations
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Denmark
Bispebjerg University Hospital
Copenhagen NV, Denmark, 2400
Sponsors and Collaborators
Bispebjerg Hospital
ALK-Abelló A/S

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vibeke Backer, Professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT01889875     History of Changes
Other Study ID Numbers: Graesallergi
First Posted: July 1, 2013    Key Record Dates
Last Update Posted: July 1, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
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Immunologic Factors
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Physiological Effects of Drugs