Walgreens and AstraZeneca are seeking volunteers.
Are you 40 to 80 years of age, diagnosed with or believe you have chronic obstructive pulmonary disease (COPD), and a current or former smoker?
Consider joining the THARROS clinical study to evaluate whether investigational treatments for COPD may help to prevent COPD flare-ups and serious heart events such as heart attacks and heart failure.
Qualified participants will receive approved treatments for COPD at no cost to them and may be compensated for their time and travel.
Study Overview
Why is the THARROS study important?
COPD, especially flare-ups, affects how well the lungs work. When the lungs are not working like they should, it puts a strain on the heart. This may lead to a higher risk of serious heart events like heart attacks and heart failure. Some people with COPD are also at risk because they smoke, which damages both the airways and the blood vessels.
Budesonide is a type of treatment called an inhaled corticosteroid (ICS). In previous studies, combination inhalers that include an ICS have been shown to help reduce inflammation and prevent COPD flare-ups. It is thought that they may also help to prevent serious heart events. That’s why AstraZeneca is studying whether an investigational inhaler with an ICS can improve heart and lung health better than one without.
Your participation could contribute to help finding treatment options that may prevent serious heart events in people with COPD.
Eligibility Criteria
You may be eligible for this study if you:
Are between 40 and 80 years of age
Have been diagnosed with COPD
Are a current or former smoker
There will be other study requirements that the study team will discuss with you, including a physical exam, vital signs, blood tests, and a lung test. You will only need to have these tests during screening to determine if the study is a good fit for you.
Taking part in this study involves:
Learning about the details of the study and giving your consent to take part
Having 11 study visits total, about every 3 to 6 months (most may be virtual)
Taking inhaled medication twice daily
If you qualify and choose to join the THARROS study, you will be randomly assigned to a study group in which you will receive either an investigational inhaler with budesonide in combination with two other medicines (BGF) or an investigational inhaler without budesonide that contains two other medicines (GFF). If you do join the study, you will switch from your regular COPD medication to the study treatment.
Whether you receive the investigational inhaler with budesonide or without budesonide will be determined randomly (by chance, like flipping a coin).
This study is double-blind, meaning neither you nor the study doctor will know which medication you received until all patients complete the study and the data are analyzed.
Frequently Asked Questions
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Clinical research is the process of developing medicines or therapies to possibly prevent, treat, or help with diseases. Before a medicine can become available, it must be tested in a series of clinical studies to understand if it is safe and effective. With the help of clinical study participants, researchers can find out if and how potential new medicines work.
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Participation in the THARROS study involves 11 study visits (most may be completed virtually) over a period up to 3 years.
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This type of inhaler contains budesonide as well as the medicines glycopyrronium and formoterol fumarate. It’s known as a BGF inhaler, or by the brand names BREZTRI and TRIXEO.
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This type of inhaler contains only glycopyrronium and formoterol fumarate. It’s known as a GFF inhaler, or by the brand name BEVESPI.
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Yes. You can decide to stop at any time and for any reason—your care will not be affected in any way.