Dr. Kenneth R. Chapman, M.D., M.Sc., FRCPC, FACP, FCCP

Information for Subjects with Severe Alpha-1 Antitrypsin Deficiency and Empysema in Central Canada

If you have severe Alpha-1 Antitrypsin Deficiency (type ZZ or SZ) and emphysema, you might be interested in a Clinical Trial of a purified human alpha-1 antitrypsin preparation Zemaira, (This product has been approved in the U.S. and has been in use since July 2003 for intravenous infusion to treat severe antitrypsin deficiency). This is a randomized placebo controlled trial; half the subjects will get Zemaira by chance and half will get by chance infusions with no active medication (placebo), 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 65 years old, and be a non-smoker or must have quit smoking for at least 6 months, and have airflow obstruction (FEV1 between 35% and 70% of predicted).  The purpose of this study is to determine if weekly infusions of Zemaira over a period of 2 years will be effective to reduce the progression of emphysema. Zemaira has not been yet approved for clinical use in Canada, but is approved for investigation in this trial.

The initial 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 2 years with visits every 3 months to Toronto and assessment by detailed breathing tests. CT scans of the chest will be performed before treatment and after 3, 12, 21 and 24 months of treatment to assess the extent of emphysema. Subjects will be reimbursed their expenses for these visits. For subjects coming from out of town, airplane travel and hotel accommodations if required will be prepaid.

As you may know, the cost of alpha1 antitrypsin intravenous therapy has gone up dramatically recently, up to $100,000 a year, but clinical effectiveness has not been proven. This study allows you to participate in this important trial to determine effectiveness. If it is effective, you will have a 50% chance of receiving the active medication at no cost and benefiting from the treatment. For more information, please contact