What is a clinical research study?

Clinical research studies help to answer questions about investigational drugs, but they can also be used to answer questions about medications that are already approved by health authorities (e.g., the US Food and Drug Administration).

Some clinical research studies, like this one, are designed to look at medications that are already approved for use. This helps to find out new information about them, such as the optimal dose to give, or what happens if a certain medication is given or used in a different way.

Even when a medication has been approved by a health authority and is known to help people, further research is sometimes needed to make sure study participants are benefiting from it and to monitor for any possible side effects.

What should I expect if I participate in this clinical research study?

Before you can take part in the GLASSIA BAL Immuno Study, you will first need to attend a screening visit for initial tests and assessments to see if you are eligible to participate in the study.

After all the necessary tests and assessments have been completed, you will be randomly assigned – like flipping a coin – into one of two treatment groups (A or B). Both groups will receive the investigational drug called GLASSIA, also known as alpha1-proteinase inhibitor (human).

Infusions will be given once a week for 25 weeks and will take place either at the study center or at your home. In total, up to six study center visits will be required during the treatment period for blood tests and other assessments. Learn more about the GLASSIA BAL Immuno Study.

Are there any contraindications I should be aware of before I participate in this clinical research study?

A contraindication is a specific situation in which an investigational drug should not be used because it may be harmful to the person. For this clinical research study, any study participant who is immunoglobulin A (IgA) deficient, has developed antibodies against IgA, and/or has a known severe allergic reaction to A1-PI products will not be able to participate. If you are IgA deficient and have developed antibodies against IgA, you may be at risk of having a severe allergic reaction to the investigational drug.

What are the most common adverse reactions seen in this clinical research study?

In a clinical research study, an adverse reaction is any unexpected, unwanted, or dangerous reaction to the investigational drug. The onset of the adverse reaction may be sudden, or it may develop over time. The most common adverse reactions seen in this study are headaches and upper respiratory tract infections.

Other adverse reactions seen in this clinical research study include coughs, sinusitis, chest discomfort, dizziness, and increased liver enzyme values.

Have there been any serious adverse reactions seen in this clinical research study?

The most serious adverse reaction observed in this clinical research study was worsening of chronic obstructive pulmonary disease (COPD).