Bringing the outdoors to the indoors: Environmental Exposure Unit

This is part of a continuing series showcasing some of Ontario’s many clinical trial strengths and assets.

When a pharmaceutical research company from India wanted to test a new nasal corticosteroid for allergic rhinitis, or hay fever, it went half-way around the world to connect with the Environmental Exposure Unit (EEU) in Kingston, Ontario.

“We were impressed by the EEU, its infrastructure, technology, and the experienced and qualified principal investigator and her team,” says Abhijeet Joshi, Manager, Clinical Research, Sun Pharma Advanced Research Company Ltd. of Mumbai, India. Colleague Dr. Atul Raut visited and reviewed the EEU, and met with all key stakeholders. He found the EEU team members “knowledgeable and experienced.”

The EEU, operated by the Allergy Research Unit of Kingston General Hospital, is what’s known as a controlled allergen challenge facility. It is designed “to bring the outdoors to the inside,” while allowing researchers to control environmental variables—including humidity, temperature and carbon dioxide levels—that can throw off the results of traditional outdoor allergy season studies.

Special EEU technology enables researchers to deliver precise levels of specific pollens throughout a large sealed room, exposing up to 140 participants at a time while testing new allergy medications. “Our participants clearly report that the symptoms they experience in the EEU are the same that they get during regular hay fever season,” says Dr. Anne K. Ellis, Director and principal investigator at the EEU and Chair, Division of Allergy and Immunology in the Department of Medicine at Queen’s University.

“The EEU is a combination of tried and tested methodologies, cutting-edge research and leading technologies. When sponsors ask me why they should come to the EEU as opposed to any other controlled allergen challenge facility in North America to do a study, I say, ‘We were the first, we’re the largest and we’re still the best.’” A Board Member of Clinical Trials Ontario, Dr. Ellis is well-acquainted with the global clinical trials landscape.

Joshi of Sun Pharma Advanced Research Company speaks positively about the EEU’s time management, its adherence to good clinical practice (GCP) standards, and the high-quality data from the large Phase II study his company sponsored, involving 220 participants. The clinical trial showed that all three doses of the nasal steroid tested for allergic rhinitis were safe and beneficial. Sun Pharma and the EEU are now collaborating to publish the study results.

Allergic rhinitis is an allergy-induced inflammation of the upper respiratory system that causes cold-like symptoms, such as a runny nose, itchy eyes, congestion, sneezing and sinus pressure. An estimated 9% to 42% of the population worldwide is currently affected by allergic rhinitis (it is hard to quantify due to inconsistency of sampling methods used in different countries), and 40% of Canadians will be affected at some point in their lives.

Although hay fever is not life-threatening, it can be debilitating and can have a major effect on people’s quality of life. The economic impact is staggering—in 1999 it was estimated to cost the American economy $5.3 billion annually.

“Allergic rhinitis is probably the most common allergic condition that affects Canadians and others worldwide,” says Dr. Ellis. “So it is important to find highly effective treatments, and more importantly, new treatments. Allergic rhinitis is associated with a huge amount of absenteeism, days missed at work and school, and ‘presenteeism,’ people showing up for work or school but they can’t focus because their symptoms are so bothersome.”

Developed in 1987 by Drs. James Day and Reginald Clark, and among the first and largest allergen testing facility of its kind globally, today’s EEU is a 3,000-square-foot unit located in Kingston General Hospital, overlooking the shores of Lake Ontario. It is the only such North American facility that is in a hospital and affiliated with a university. The EEU conducts clinical trials of new medications for allergies to ragweed, trees and grasses, and plans are underway for dust mite studies

Most participants are recruited from a database of 2,000 to 3,000 individuals, typically ages 18 to 65, but some studies include people up to age 70.

The EEU has conducted more than 40 Phase II, III and IV clinical trials for companies mainly from the U.S. and Europe, resulting in more than 25 articles published in peer-reviewed journals.

An article just submitted to a scientific journal is based on findings of a Phase IIb clinical trial at the EEU that Dr. Ellis calls “one of our most recent crowning achievements.” The trial involved a partnership with Circassia of Oxford, England, a specialty biopharmaceutical company focused on allergy and respiratory disease, and Adiga Life Sciences Inc., which is jointly owned by Circassia and McMaster University in Hamilton, Ontario.

Circassia and Adiga chose the EEU to test their next generation of immunotherapy for grass allergies, the most common form of hay fever that affects 17% to 27% of people in the U.S. and Europe. Circassia’s synthetic peptide immuno-regulatory epitopes (SPIREs) aim to treat the underlying allergic disease with a short-course therapy, and consequently have the potential to revolutionize treatment by providing well tolerated long-term control.

In the EEU clinical trial, the optimal treatment group was shown to have reduced allergy symptoms at the end of the first grass pollen season. Symptom improvement was sustained over the following two grass pollen seasons when measured in those returning each season, despite no further treatment. The SPIRE treatment involves fewer injections over a much shorter period of time than traditional allergy immunotherapy.

“It’s a wonderful finding,” says Kristen Armstrong, Clinical Research Manager at Adiga Life Sciences, speaking on behalf of the clinical trials team. “The data showed that the treatment is well tolerated and has the potential to improve symptoms over a sustained period following just a short course.

“The EEU team is very conscientious and detail-oriented, so you know the data that comes out of there is reliable and of good quality. In addition, Dr. Ellis’ close involvement is very welcome helping ensure the smooth running of the study.”

For more information, visit the Environmental Exposure Unit website

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