Allergy
We Provide More Than Patients With the Right Allergies. We Provide the Right Environment to Challenge Them.
Accurate evaluation of potential allergy treatments requires controlled exposure to a precise level of allergens. Cetero’s Environmental Exposure Chamber (EEC) models enhance both precision and speed of your drug development.
We have developed and fully validated models for cGCP compliant studies. They provide rapid clinical solutions for the early development of small molecule biologics, immunotherapies and therapeutic devices for a broad range of indications, including:
- Allergic Rhinoconjunctivitis – Seasonal Allergic Rhinoconjunctivitis (SARC), Perennial Allergic Rhinoconjunctivitis (PARC)
- Non-allergic Rhinoconjunctivitis (NARC) – NAR with Eosinophilia Syndrome (NARES) and VasoMotor Rhinitis (VMR)
We introduce aeroallergens into the EEC in a highly controlled fashion that mimics what patients would be exposed to in their everyday lives, whether it’s high pollen days, for seasonal allergy models, or low persistent allergen exposures in the home, for perennial allergy models.
Our chambers have been fully validated for several allergens, including ragweed, grass and tree pollens, dust mite and cat dander. Unlike field studies, chamber-based studies can be run at any time of the year with little variation in allergen exposure.
Patient compliance is 100%, since participants are continuously monitored. Cetero’s superior EEC model study designs and standard operating procedures result in low data variability and highly significant clinical outcomes. Cetero’s expert technologists are trained in SOPs for measures such as acoustic rhinometry, pulmonary function testing and nasal lavage.
Dose ranging and comparator study designs facilitate dose selection. And after drug approval, EEC studies provide FDA-accepted data towards label claims such as onset and duration of action for both nasal steroid and antihistamine drug categories.
Cetero’s chamber technology maximizes patient symptoms and reduces their variability, so studies require fewer patients and move more quickly than traditional field allergy trials. The model can be combined with our First to Proof-of-Concept service to significantly reduce the time to develop data and accelerate go/no-go decisions.
So don’t wait for allergy season. Contact Cetero and we’ll custom design and execute the ideal allergy study for your clinical development needs.
