Allergic Rhinitis (AR)
Allergic Rhinitis (AR) is the most common chronic atopic disease and is associated with considerable cost and co-morbidity. Allergic rhinitis is an inflammatory condition of the nasal mucosa which is initiated by an IgE-mediated response to allergens and results in a consequent release of preformed mediators and cytokines, which induce inflammatory cell recruitment and their activation at the target organ. AR is classed as Intermittent/Seasonal (SAR) or Persistent/Perennial (PAR). SAR is triggered by pollen from trees, grasses and weeds, is characterized by sneezing, nasal congestion, nasal itching, rhinorrhea, and pruritic, watery, red eyes. PAR is triggered by allergens which are commonly found at any time of year in the indoor environment such as dust mite or cat allergen.
The use of the EEC model for clinical trials to study allergic rhinitis have been encouraged by the FDA and its European counterpart, The European Agency for the Evaluation of Medicinal Products (EMEA), due to reduced study variability and superior sensitivity to discern drug efficacy parameters such as onset of action, dose-response and optimal dosing. Allied Research International (ARI) has extensive experience in conducting clinical trials in Environmental Exposure Chambers (EEC) for the study of Seasonal Allergic Rhinitis (SAR).
Our first EEC, built in 2001, has been used for many large Phase II-III type clinical trials to study the onset of action and comparative efficacy of anti-allergy drugs. To date, ARI has conducted more than two dozen EEC studies involving more than 3,000 subjects. Data from these studies has been published in peer-reviewed journals and presented at international conferences.
Seasonal Allergic Rhinitis (SAR)
ARI has EEC designed and validated to deliver predetermined aeroallergen levels within tight tolerances. EEC#1 and EEC#2 have been validated for grass, tree and weed pollens such as mixed grasses (including Timothy Grass (sp. Phleum pratense), Orchard Grass (sp. Dactylis glomerata), Kentucky Blue Grass (sp. Poa pratensis), Red Top Grass (sp. Agrostics alba), Perennial Rye Grass (sp. Lolium perenne) and Meadow Fescue Grass (sp. Festuca eliator)) , birch (sp. Betula) and oak (sp. Quercus) and ragweed (sp. Ambrosia) with Japanese Cedar (sp. Cupressus japonica) currently in validation. EECs #1 and #2, respectively, have 121 and 60 subject seating capacity.
Perennial Allergic Rhinitis (PAR)
The EEC model can also be used to study Perennial Allergic Rhinitis (PAR) in which common perennial allergens studies include dust mite and cat allergens are tested. ARI has two chambers, EEC#3 and EEC#4, in which allergy to dust mite and cat allergens can be tested. The dust mite chamber can accommodate 30 subjects and the cat chamber is smaller with a 5 person capacity. Both chambers are state-of-the-art chambers in which proprietary methodologies and technologies have been developed in collaboration with leaders in the fields of allergy, asthma and indoor air quality engineers. The cat allergen chamber, EEC#4, is based on the natural cat chamber model and is an ideal setting in which to test the effectiveness of prophylactic anti-allergic treatments.
Pharmacokinetic Profile testing with and without nasal congestion due to Allergic Rhinitis (AR)
A number of nasal delivery drugs are now emerging that are not for the treatment of AR but are systemically acting. This increase in nasal spray (topical) delivery therapies is due to the drive to improve patient compliance (in some cases like insulin it is to “avoid needles”), to avoid first-pass metabolism and to realize a rapid onset of action. The FDA has acknowledged the possibility that nasal sprays could be impaired by nasal congestion with AR, and has encouraged that nasal spray delivery drugs be tested under conditions of AR and decongested AR. ARI-Cetero is uniquely placed with a combination of pharmacokinetic capabilities and the ability to induce reliably and less variable AR symptoms using the EEC model; and as such, is the perfect place to conduct such specialized clinical studies.
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