A Novel Biologic Therapy for Perennial Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept
      study which will evaluate the effect of a preparation of FDA approved allergens (PMA) used as
      a sub-cutaneously administered immunotherapy for the management of allergic rhinitis
      (perennial and seasonal).
    

Detailed description: 
      This is a randomized, parallel-group, double-blind, phase 2, single center, proof-of-concept
      study which will evaluate the effect of a proprietory mixed preparation of FDA approved
      allergens (PMA) used as a sub-cutaneously administered immunotherapy for the management of
      allergic rhinitis (perennial and seasonal). Participating study subjects will be required to
      manifest the signs and symptoms of allergic rhinitis and test positive to at least six
      allergens using a multi aeroallergen screen at the time of study recruitment . All subjects
      will undergo standard allergen skin prick testing using six Multi-Test® PC skin prick test
      devices (Lincoln Diagnostics, Decator, IL) or comparable skin testing technique for a total
      of 48 Skin Prick Test (SPT). Approximately 36 total subjects will be enrolled.

      Following a successful screening study visit and two week medication washout period, a 8 week
      treatment period will be initiated with bi-weekly study visits being undertaken, through to
      the end of immunotherapy, for assessment of therapeutic response and safety evaluations.
      Efficacy evaluation will be monitored using validated instruments that assess study subject
      clinical response, physician global assessment, and medication use. A safety assessment will
      be undertaken one month following completion of treatment.

      At the screening visit (Screening Visit) a potential study subject will be required to
      fulfill the requirements of the study inclusion and exclusion criteria, will have a clinical
      evaluation including medical history and physical examination, blood draw and performance of
      skin testing. The study subject will then abstain from using intranasal steroids and
      antihistamines for two weeks and then return to the clinic for administration of
      sub-cutaneous PMA and post-treatment in-clinic safety evaluation. The latter evaluation
      period will comprise approximately 60 minutes to assess the study subject's response to PMA
      immunotherapy. Follow up clinic study visits will continue bi-weekly through 8 weeks and at
      each of these visits the study subject will receive increasing doses of PMA immunotherapy and
      will be evaluated for safety. Twice weekly clinical evaluation will also be performed.
      Following the final administration of PMA immunotherapy, a one month follow-up safety and
      clinical efficacy evaluation will be conducted by telephone or in the clinic. The duration of
      the study will be approximately 14 weeks.
    

Intervention name(s): Allergen Immunotherapy Extract; Allergen Immunotherapy Control
Intervention type(s): Drug; Drug
Intervention description(s): Allergen Immunotherapy treatment mixture to be delivered subcutaneously; Allergen Immunotherapy Control Solution to be delivered subcutaneously
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment