Efficacy Study of Sublingual Immunotherapy to Treat Ragweed Allergies
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine an effective dose range for the administration of
      ragweed allergenic extract via the sublingual route of administration
    

Detailed description: 
      Specific allergen immunotherapy as currently practiced in the USA and described in product
      labeling comprises the subcutaneous injection of incrementally increasing doses to a targeted
      maintenance dose ("build-up") followed by maintenance injections of allergenic
      extract/vaccine. Up to 30-40 injections may be required during the build-up phase over a 3-6
      month period. When adequate maintenance doses are reached, this form of immunotherapy (SCIT)
      has been shown to be highly effective and safe.

      Standard practices recommend that the injections be given under the supervision of trained
      physicians and that the patient remain in the physician's office at least 20 to 30 minutes
      after an injection. The administration of immunotherapy injections are not recommended at
      home because of the risk of inadequate recognition and treatment of systemic reactions. The
      inconvenience and expense of traveling for allergy injections and the discomfort of the
      repeated injections is a disincentive to this form of treatment particularly in pediatric
      patients. For example, dropout rates exceeding 50% over a multi-year course of injection
      treatment have been reported.

      Alternative routes for immunotherapy have been explored, especially in Europe in an attempt
      to improve patient compliance and to minimize the risk of serious adverse reactions. For
      example, sublingual-oral immunotherapy (SLIT), which is the administration of the allergenic
      extract/vaccine under the tongue for 1-2 minutes followed by swallowing, has been proven to
      be efficacious and safe in several double-blind, placebo-controlled studies. A recent
      Cochrane Review concluded, "SLIT is a safe treatment, which significantly reduces symptoms
      and medication requirements in allergic rhinitis."

      Efficacy studies support the use of SLIT for the treatment of rhinitis or rhinitis and
      asthma. However, dosage schedules are highly variable and optimal maintenance doses have not
      yet been established. Thus, dosing studies should be designed to investigate not only the
      safety profile but to determine optimal doses for maintenance therapy of patients built-up by
      injection IT and for build-up regimens of previously untreated patients.

      Much of the United States medical community's hesitation to embrace sublingual immunotherapy
      as a viable treatment option for allergy patients has stemmed from limited information using
      U.S. licensed allergenic extracts for this treatment route. Additionally, the
      cost-effectiveness of one form of therapy over the other has not been clearly evaluated and
      the third-party payers have not accepted SLIT for insurance coverage.
    

Intervention name(s): Standardized Ragweed Allergenic Extract; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Standardized Ragweed Allergenic Extract, sublingual oral; Placebo, sublingual oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergy; Sublingual Immunotherapy; Allergic Rhinitis