Efficacy Study of Sublingual Immunotherapy to Treat Ragweed Allergies
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Standardized Ragweed Allergenic Extract; Placebo
Intervention description: Standardized Ragweed Allergenic Extract, sublingual oral; Placebo, sublingual oral
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 430.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Allergy; Sublingual Immunotherapy; Allergic Rhinitis

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
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult ragweed-sensitive Subjects with allergic rhinoconjunctivitis with or without
             asthma during ragweed pollen season.

          -  Subjects must be 18 to 50 years of age.

          -  Test Subjects will have a history of moderate to severe isolated or unseasonal
             allergic rhinoconjunctivitis with or without mild intermittent asthma symptoms
             attributable to ragweed pollen for a minimum of 2 years before study entry.

          -  Subjects with or with out a history of asthma will possess FEV1 and PEF greater than
             or equal to 80% predicted at the beginning of the study established by spirometry and
             defined by the Knudson predicted set.

          -  Sensitivity to the relevant allergen will be documented by a positive skin prick test
             result performed along with negative (saline) and positive (histamine) control skin
             tests. A positive test will be defined as the skin reaction having the longest wheal
             diameter of 5mm or greater or the longest erythema diameter of 10 mm or greater at
             15-20 minutes after application.

          -  All female Subjects of child-bearing potential will be required to provide a urine
             sample for pregnancy testing that must be negative before being allowed to participate
             in the study.

          -  Subjects must be planning to remain in the study area during the trial (see exclusion
             criteria # 14).

          -  Subjects must be trained on the proper use of the EpiPen, and sign the EpiPenTraining
             Form before being allowed to enroll in the study.

          -  Subjects must be mentally and physically capable of self-administering oral drug.

        Exclusion Criteria:

          -  Subjects having a history of anaphylaxis or history consistent with persistent asthma

          -  Subjects taking antihistamines or nasal steroids medications greater than twice a week
             in the months of January and/or February.

          -  Subjects with chronic sinusitis unstable angina, significant arrhythmia, uncontrolled
             hypertension, or other chronic or immunological diseases that in the opinion of the
             investigator might interfere with the evaluation of the test drug or pose additional
             risk to the Subject.

          -  Subjects having perennial or structurally related rhinitis or rhinitis medicamentosa
             (from excessive use of nasal decongestants) that will interfere with the evaluation of
             symptoms due to ragweed allergy.

          -  Subjects with an FEV1 or PEF less than 80% predicted (moderate persistent asthma) with
             or without controller medication.

          -  Subjects who have received an experimental drug in the 30 days prior to admission into
             this study or who plan to use an experimental drug during the study.

          -  Subjects who have received Anti-IgE medications (Xolair) or similar compounds in the
             last 12 months.

          -  Subjects who have received ragweed allergen immunotherapy in the last 3 years prior to
             admission into this study.

          -  Subjects who are current users of inhaled, oral, intramuscular, intravenous
             corticosteroids, tricyclic antidepressants, beta blockers, or MAO inhibitors.

          -  Subjects using beta-agonist more than twice a month unless being taken prior to
             exercise.

          -  Subjects using medications that could induce adverse gastrointestinal reactions during
             the study. Subjects using such medications must prove stable with no side effects for
             at least 3 months prior to enrollment.

          -  Subjects refusing to sign the EpiPen Training Form will be excluded from the study.

          -  Pregnant or breast feeding females.

          -  Subjects who plan to leave the study area for more than 2 consecutive weeks during the
             study.

          -  Subjects with a positive skin prick test to cat and/or dog, and own the pet(s) to
             which they are allergic.

          -  Subjects who sleep during the day due to working third shift.

          -  Subjects unable to achieve dose #2 or higher during preliminary dosing will be
             excluded.