Comparability and Standardization of Controlled Allergen Challenge Facilities
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Allergen challenge facilities have been utilized for many years in clinical drug trials
      studying onset of action, proof of concept, duration of action, and efficacy. Each facility
      has somewhat different design characteristics and pollen dispersal technologies. Facilities
      are located in disparate geographic areas and have populations of participants who are
      sensitized to allergens unique to that area. Therefore, facilities have operated as single
      sites with little effort to evaluate facility comparability or to attempt standardization
      across facilities. The purpose of this study is to compare the two sites and assess whether
      the sites are able to achieve similar symptom scores.
    

Detailed description: 
      When CACF have been designed with a high degree of rigor, quality assurance and validation
      testing, the exposure to controlled levels of pollen in such facilities as the Environmental
      Exposure Unit (EEU) and the Biogenics Research Chamber (BRC) will demonstrate
      comparable/standardized symptomatic responses. This will be demonstrable not only following
      pollen exposure but will also have similar reductions in symptoms following treatment with a
      Food and Drug Administration (FDA) approved medication known to be effective for the
      treatment of seasonal allergic rhinoconjunctivitis ( SAR); cetirizine 10mg. Because of
      quality assurance and validation testing completed at these facilities a priori, this
      comparability will be demonstrated despite their disparate geographical physical locations
      and the utilization of these facilities of somewhat different mechanical and technical
      materials and methods to achieve similar outcomes.

      This multi-center study of SAR will enroll 50 participants at each site. These participants
      will be age 18-65, male and female, with a mixture of ethnic groups. The study will involve 3
      Phases: Screening, Treatment Exposure Visit, and a cross-over Treatment Exposure Visit. In
      all stages, a CACF visit will be pivotal to determine participant eligibility for enrollment
      and response to therapy. The qualifying participants will receive a double-blinded,
      placebo-controlled, crossover intervention with cetirizine HCl 10mg.

      All participants will give written informed consent prior to any study related procedures
      being performed. Participants who meet all inclusion/exclusion criteria during the screening
      process will be asked to return to the EEU for their first pollen exposure visit (Treatment
      Visit #1). At the Screening Visit participants will provide a full medical history and
      undergo a physical examination. They will have their height/weight and vitals measured and
      skin testing will be performed to confirm allergic response to a panel of common
      aeroallergens. Women of child bearing potential will undergo a urine pregnancy test to rule
      out pregnancy. Eligible participants will be invited back to the research centre for 4 pollen
      exposure visits at 2 of these visits participants will receive either cetirizine or placebo.
      All participants will receive placebo at some point throughout the study.
    

Intervention name(s): Cetirizine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive either cetirizine (10mg tablet, orally) or a placebo (sugar pill) at one of the two treatment visits.; Participants will receive either a placebo or cetirizine (10mg tablet, orally) at one of the two treatment visits
Other intervention name(s): Zyrtec; Reactine
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other