What is the EEU?

Surrounded by the campus of the prestigious Queen's University; Kingston General Hospital, an acute care teaching hospital, is home to the internationally recognized Environmental Exposure Unit (EEU).

This unique facility, conceived of and pioneered by Dr. James Day and Dr. Reginald Clark in the early 1980s, has been refined and developed over the past two decades garnering it recognition around the world and bringing to you an innovative new way to conduct allergy research trials. As a fully validated and GCP compliant research environment, the EEU has been used to evaluate the onset of action and efficacy of antihistamines, nasal corticosteroids and other investigational medications in the treatment of allergic rhinitis and resulted in studies undertaken by a majority of the multinational pharmaceutical companies involved with anti-allergic treatments. As a highly controlled indoor environment, the EEU eliminates the variables of weather, subject environment, and the changing antigenicity of seasonal ragweed so that studies can be conducted at any time of the year and subject responses to the allergen of interest can be readily evaluated. The EEU is recognized by the U.S. FDA and European Medicines Agency (EMEA) as a means to assess onset of action of anti-allergic treatment.

The EEU is designed to deliver controlled reproducible levels of allergen, for example ragweed pollen, to allergic subjects. The EEU's allergen dispersion system circulates pollen through the room at peak-pollen levels typical of a late-summer day. Subjects - from 5 up to 160 at a time - are exposed to pollen in a conducive environment. Allergic volunteers experience typical allergy symptoms and with guidance from physicians and researchers, detect and record their response to anti-allergic medications. EEU research has shown that subjects are able to detect differences in their responses to different medications and doses, and when studies are repeated the results are reproducible, even when trials are conducted at different times of the year and years apart. This means that conclusions drawn from EEU research are highly reliable and can be applied in medical practice.

Although others have attempted to emulate the Environmental Exposure Unit model, conducting your studies with the innovators of this specialized research environment will give you the advantage that can only be found with those that fully understand the capabilities and procedures and will ensure you maximize your research potential. Start your next project with the best in allergy research.

An evolution of allergy research.

History of the EEU.

The Environmental Exposure Unit (EEU) is an advanced tool for evaluation of anti-allergic medications.

Dr. James Day (MD) and Dr. Reg Clark (P Eng Chem at Queen's University) began working on an allergen delivery system in 1981, an evolution based on this research collaboration for the investigation of the effects of urea formaldehyde foam insulation (UFFI) on the human respiratory system. Their original environmental chamber was an aluminum-framed polyethylene tent attached to a UFFI off-gas generator. In this system, air flowed from the generator into the tent where over 30 subjects were seated and exited from the opposite side.

With the success of the original chamber and the realization that similar technology would be highly relevant for the study of allergic rhinitis, this led to the modification of a room at Queen's University with a filtered air intake and exhaust system allowing for larger-scale studies involving up to 60 subjects. The original delivery system was engineerd to handle ragweed pollen and included the development of a unique feeder system and computerized controls to deliver precise amounts of particulate to the controlled environment of the room. A specialized rotorod and laser particle counter system was developed to measure and ensure consistent levels of pollen were being circulated evenly throughout the room thereby assuring that each study subject received the same level of allergen exposure during the study.

As more studies were conducted and the effectiveness of the EEU proven, the EEU was moved to a larger, specialized location within the Kingston General Hospital capable of accommodating up to 160 subjects. While the EEU's systems have been and continue to be refined, it was these innovators in Kingston that built upon the original controlled-exposure concept to make the EEU into the internationally recognized facility that it is today.

Learn how the EEU sets the standards for allergen challenge chambers around the world.

The EEU Today.

Today's EEU is a combination of tried and tested methodologies, cutting edge research and leading technologies.

The EEU is more than a sum of its parts. Over the years, ongoing development combined with understanding, passion and expertise has led to the creation of a highly unique and specialized model to conduct allergy research. EEU researchers are unmatched in this field and have the experience to ensure that your research project can be successfully implemented in the EEU.

The EEU is a large allergen challenge chamber capable of seating as few as 5 or up to 160 subjects.

The EEU is located within the Kingston General Hospital, a true advantage over stand alone facilities. Occupying a large room overlooking Lake Ontario and the St. Lawrence River, the EEU can accommodate small or large groups of subjects for extended allergen exposure sessions. The EEU is centrally located in the hospital with the advantage of direct access to hospital facilities and services. Having a full emergency department in close proximity to the EEU is a pronounced safety factor during clinical trials.

Proprietary systems and stringent monitoring ensure that the levels of allergen maintained in the EEU remain within protocol requirements.

As the innovators of the EEU model, the allergen delivery system and ability to keep the allergen suspended in the EEU were the critical elements that allowed this model to move forward. The EEU allergen delivery system is proprietary and has been developed to ensure that allergen levels can be maintained continuously at predetermined concentrations in this setting. By delivering the allergen directly into the room and not through an air handling system, no specialized cleaning routines are required for the filtered air system and, consequently, this potential source of contamination is not a factor. An independent, world renowned Air Quality consultant verifies that all standards are met or exceeded by taking measurements during each study to document air quality and confirm that no other factors may be impacting on study results. EEU engineers and the specialized systems that they have developed generate allergen concentrations that can be maintained at the protocol specified levels. Seven Rotorod samplers placed within the subject seating area in the EEU directly measure allergen levels to confirm and document that the same concentration of allergen is delivered to the study participants. Stringent cleaning routines are in place to make certain that no residual allergen remains in the EEU between study visits. With these specialized systems and documented procedures, the conditions in the EEU can be reliably reproduced at each study visit, ensuring the very important requirement that participants in each study cohort receive the same allergen exposure and thereby allowing studies to be undertaken at any time of the year. The pioneering technology designed by Dr. Reg Clark was integral to the development of the EEU. Refinements which have been subsequently implemented have ensured that the allergen delivery in the EEU remains the benchmark in allergen challenge research.

Symptom data is collected in real-time allowing an unprecedented level of error checking to ensure that data is as thorough and complete as possible.

Many subjective or objective outcomes can be measured in the EEU to monitor medication performance or the status of subject's allergies. Subjective symptom scoring is the preferred primary outcome and a sophisticated, real-time method of symptom reporting has been developed specifically for use in EEU studies. As subjects in the EEU complete their symptom diaries at predetermined intervals, the symptom diaries are collected and electronically checked in real time. Should any incomplete diaries or errors be indentified, the scoring sheet is immediately returned to the study subject so that the missing information can be completed or errors corrected. By reviewing and capturing the data electronically in real time, it is assured that 100% of the symptom data is available for analyses quickly after the study is completed.

Patient compliance is 100% and adherence to Standard Operating Procedures enables quality study results.

The controlled environment of the EEU allows for constant monitoring of study participants by physicians, nurses and research staff who are always present in the room with the study subjects. All procedures within the EEU are directed by a session leader to make certain that each study cohort receives identical study instructions and all protocol defined procedures are untaken in the same manner. Standard Operating Procedures are in place and strictly followed for all study related procedures to minimize data variability and ensure that study conditions are reliably replicated. EEU studies allow for 100% patient compliance and produce reliable, robust, high quality data, both significant factors which help to ensure that your study is completed correctly and on time.

To discuss your research program and how an EEU clinical trial might be implemented in your development program, please contact us today.