“The go-to experts in Allergy and Asthma research”
Cetero Research is the only professional Contract Research Organization (CRO) that has developed and fully validated models in the Environmental Exposure Chambers (EEC) for cGCP compliant studies. The EEC Model is a validated, rapid and FDA-accepted clinical solution for the development of small molecule drugs, immunotherapies and therapeutic devices. The EEC is ideal for a broad range of indications, including:
Allergic Rhinitis and Conjunctivitis - Seasonal Allergic Rhinitis (SAR), Perennial Allergic Rhinitis (PAR)
Perennial Non-allergic Rhinitis (PNAR) - NAR with Eosinophilia Syndrome (NARES) and VasoMotor Rhinitis (VMR)
Asthma - Allergic Asthma, Dust Mite and Cat Allergens
Dry Eye Syndrome or Keratoconjunctivitis Sicca
The successful application of Cetero’s EEC technology results in studies that are faster and have less variability than traditional field or “day in the park” studies. Accordingly, EEC studies usually require fewer participants. In short, the EEC can give your development program better quality data in a shorter timeframe.
Interested in learning more about this innovative technology? Please contact us.
Environmental Exposure Chambers (EECs) in Action
The EECs at Cetero have been custom engineered to meet high air quality standards. For the conduct of allergy and asthma clinical trials, aeroallergens are introduced into the EECs in a highly controlled fashion. Our chambers have been fully validated for several allergens, including ragweed, grass and tree pollens, and their circulating levels are maintained according to tight, quality-controlled standards. In order to simulate a heavy, in-season pollen day, subjects are exposed to allergens over a period of several hours. Unlike field studies, EEC studies can be run at any time of the year with little variation in pollen exposure. Studies typically utilize pre-established allergen levels known to induce allergic rhinoconjunctivitis symptoms at the moderate to severe level. The resulting high symptom scores maximize the capacity of the study to discern treatment efficacy in a small number of patients.
To investigate perennial non-allergic rhinitis (PNAR), non-allergic atmospheric irritants are circulated into Cetero’s state-of-the-art EEC at controlled levels, similar to the approach with aeroallergens as mentioned above. The design of this EEC also facilitates customization of environmental conditions such as low relative humidity, small changes in barometric pressure and application of cold and warm air currents. This allows the conduct of clinical studies involving indications affected by environmental changes, such as vasomotor rhinitis and dry eye.
Patient compliance is 100% since subjects are continuously monitored within the EECs by highly trained staff, thus rapid and robust symptom recording is performed. Superior EEC model study designs and standard operating procedures result in low data variability and highly significant clinical outcomes that have proven efficacy and onset of action claims for both nasal steroid and antihistamine drug categories; these have been accepted by the regulatory authorities.
Interested in learning more about this innovative technology? Please contact us.
