PACEMAKER: Spring 2006

Trials Open to Patients

Severe asthma

Patients diagnosed with severe asthma are invited to participate in a clinical trial to evaluate the effectiveness of an investigational medication called CNTO 148 (produced by Centocor) in reducing the symptoms of their condition. Participants will receive either the drug or a placebo (an inactive substance). CNTO 148, which has not yet received approval from the FDA, is an antibody that has been manufactured in a laboratory. CNTO 148 has been shown in other studies to block the activity of an asthma-related substance called tumor necrosis factor alpha. The study is open to participants 18 or older who need both a bronchodilator and daily control medicines to treat ongoing inflammation. Compensation is available.

PRINCIPAL UI INVESTIGATOR: Joel Kline, M.D.
CONTACTS: Call Jackie Loesche or Sandy Reed at 877-428-0635 or 319-356-3240, or e-mail jacquelyn-loesche@uiowa.edu or sandra-reed@uiowa.edu.

Cardiogenic shock

Patients diagnosed with cardiogenic shock as a complication of acute heart attack are being recruited for enrollment in a clinical study (TRIUMPH) to assess the safety and efficacy of Tilarginine Acetate injection, a new drug that temporarily stops the body from making a bodily substance called nitric oxide. The body may produce excess nitric oxide following severe heart damage leading to shock. During a heart attack, a large amount of nitric oxide is released into the heart muscle and into the blood. Normally small amounts of nitric oxide are good for the heart and blood vessels. However, when released in large amounts, such as during a heart attack, it may worsen the damage and lower the heart’s ability to pump blood. If Tilarginine Acetate injection can stop extra nitric oxide from being made, the performance of the heart and blood flow to vital organs might be improved. Qualifying participants will randomly be assigned to receive either Tilarginine Acetate injection or placebo (an inactive substance).

PRINCIPAL UI INVESTIGATOR: Phillip A. Horwitz, M.D.
CONTACT: Referring physicians should call UI Consult toll-free at 800-322-8442 and ask for Interventional Cardiology research coordinator Amy Ollinger, R.N., call Ollinger directly at 319-353-6675, or e-mail amy-ollinger@uiowa.edu.

Japanese encephalitis

University of Iowa investigators are conducting a study of a new, investigational Japanese encephalitis vaccine. The vaccine not been approved by the U.S. Food and Drug Administration (FDA) for general use. Currently there is only one licensed vaccine in the United States, Australia, and Europe for the prevention of Japanese encephalitis. Compared to the old vaccine, this new vaccine appears to be longer acting, better tolerated, and it does not require booster immunizations. To qualify, participants must be at least 18 years of age and have never been infected with, nor vaccinated against, Japanese encephalitis. Compensation for study participants is available.

UI STUDY LEADS: Greg Gray, M.D., and James Gill, M.D.
CONTACT: For more information, call 319-384-5055 or toll-free 800-348-4692.