Clinical Trials

Clinical trials are research studies performed on human subjects. Studies conducted on animals, in test tubes, or using various other laboratory techniques are often called basic research. Clinical trials may include studies to evaluate the course of a disease, its cause or a treatment. Testing of new drugs or therapies is often the most visible and exciting type of clinical trial. In Canada, clinical trials that evaluate a new drug or pharmaceutical therapy fall under very strict regulation by Health Canada. Health Canada decides whether the studies performed show that a drug is effective enough and safe enough to warrant broad distribution of the drug to patients. You can register with the Alpha-1 Canadian Registry to find out about clinical trials and research projects you may be eligible to participate in. Participating in research is a tangible way for you to take part in the quest to improve the lives of all Alphas – including yourself – and be a part of eventually finding a cure for this devastating disease. Dr. Kenneth R. Chapman, M.D., M.Sc., FRCPC, FACP, FCCP

Information for subjects with Alpha1-antitrypsin deficiency & emphysema

If you have Antitrypsin Deficiency (type ZZ, SZ, Z (null), (null) (null), S (null), or “at-risk” alleles and emphysema, you might be interested in a Clinical Trial of Alpha-1 MP. (This product has been approved in Canada for intravenous infusion at a dose of 60 mg/kg/week, to treat severe Antitrypsin Deficiency). This study is considered research because the infusions have not been approved in all countries or at the higher dose of 120 mg/kg/week. Participants in the study will either receive 60 mg/kg/week of study drug, 120 mg/kg/week of study drug or a placebo (no active medication).This is a randomized placebo controlled trial; which means you are put into one of the 3 groups by chance and neither you nor the study doctor will know whether you are receiving active medication or placebo. To be eligible, you must be 18 to 70 years old, and be a non-smoker or must have quit smoking for at least 12 months, and have airflow obstruction (FEV1 between 30% and 80% of predicted). The purpose of this study is to determine if weekly infusions over a period of 3 years will be effective to reduce the progression of emphysema. The initial 3 infusions will be given under physician supervision in Toronto, and subsequent infusions will be given weekly at subjects’ homes by qualified nurses. The treatment is over a period of 3 years with visits every 3 months for the first year, then every 6 months for the second and third year in Toronto. Subjects will be reimbursed for their travel expenses for these visits. For subjects coming from out of town, airplane travel and hotel accommodations if required will be prepaid. For more information, please contact Jane Duke, Clinical Trials Coordinator, Asthma & Airway Centre EW7 Room 445, Toronto Western Hospital -Toronto, Ontario M5T 2S8 – 416 603 5800 ext 3438 – Fax: 416 603 5020 jane.duke@uhn.ca

Advance the research into Alpha-1 Antitrypsin Lung Disease

About the Astraeus Study

With the Astraeus Study, they are testing the safety of a research drug and whether it has the potential to reduce lung damage and slow the progression of lung disease caused by Alpha-1 Antitrypsin Deficiency. The research drug, Alvelestat, is taken as tablets and has already been tested in people with other lung diseases.

You may be eligible to participate if you:

• Are 18 to 75 years old
• Have Alpha-1 Antitrypsin Deficiency Lung Disease

Enrolled participants will receive all study-related care, testing, and study medication at no cost.
To learn more about the Astraeus Study, contact jduke@inspirationresearch.ca or 416 944 9602, or visit Inspirationresearch.ca