Safety and Efficacy of Experimental Drug for Interstitial Pulmonary Fibrosis

Study Summary

The University of Chicago and Dr. Noth are conducting a research study to understand the efficacy and safety of an experimental drug in subjects with IPF. The experimental drug being used in this study is currently not approved by the Food and Drug Administration (FDA). People with IPF experience a combination of inflammation and scarring (fibrosis) of the lungs. The cause is currently unknown. This fibrosis can build up so that the lungs are unable to provide oxygen to the tissues in the body. As the air sacs of the lungs become more damaged and scarred, there is stiffening of the lung and this stiffening makes breathing difficult and causes you to feel breathless.

The study is a randomized trial, which means that you will be randomly (like a flip of a coin) assigned to one of the four treatment groups. Three groups are different doses of the study drug, and one group receives inactive product called placebo. After you have been "screened", or determined to be eligible for the trial which can take up to four weeks, the drug will be administered intravenously (through a vein in your arm) on a monthly basis. Some of the procedures that may be done during the study include physical examinations, Tuberculosis evaluation, CT scan and lung function testing. This expected length of study is 74 weeks with 17 visits to the clinic. You may receive the drug up to 12 months.

You will be paid $30 for each completed study visit.

Benefits

There may be no benefit to you for participating in this study. However, this study will provide you and us with a detailed assessment of your heart function and exercise ability. It will also help us to understand if regular exercise affects illness and survival of heart failure patients, which may lead to better treatments in the future.

Participation Details

Initial selection criteria include:

• Must be 40 to 80 years of age
• Must be diagnosed with Interstitial Pulmonary Fibrosis within the last four years
• Have no history of tuberculosis
• Must meet study medical criteria as evaluated by Dr. Noth

Study Director: Dr. Imre Noth
Department: Pulmonary

For more information contact:
Spring Maleckar
smalecka@medicine.bsd.uchicago
(773) 834-4053

IRB: #16563B