Planning allergy studies can be very challenging because of variable weather, pollen variance among site locations, indoor/outdoor lifestyle of patients, study medication compliance, and limited enrollment periods.
The use of Environmental Exposure Units (EEU) can help sponsors address these variables through strictly controlled conditions. This includes variables for air quality, temperature, humidity, and precise maintenance of allergen concentration. In the US FDA’s “Draft Guidance for Industry: Allergic Rhinitis: Clinical Development Programs for Drug Products” EEU studies are recognized as systems for evaluation of onset of action of anti-allergic medications and prophylactic treatment for seasonal allergic rhinitis (SAR).
Pharm-Olam has experience working with EEUs in North America and Europe, including Queen's University; Kingston General Hospital EEU in Canada which has over 20 years of EEU research experience.