Where is the trial being conducted?
The most accurate and up-to-date list of EASE Trial sites is maintained at the www.clinicaltrials.gov website (search for emphysema; the trial number is NCT 00391612). New sites are added to this list when they are qualified to accept patients into the trial.

What is the name of the experimental treatment being studied?
The procedure is called airway bypass. For more information, go to the "About Airway Bypass" page of this website.

What do you mean by "advanced widespread" emphysema?
When you have emphysema, the air sacs and airways in your lungs are damaged. This damage can be concentrated in a just certain area of your lungs (for example, at the top of your left lung), or spread throughout both your left and right lungs. When the damaged is confined to a specific area, it is called "heterogeneous" emphysema. The EASE Trial is not meant for people with this type of emphysema. Instead the trial is recruiting patients who have damaged tissue distributed through different parts of their lungs. This is called "homogeneous" emphysema.

How am I supposed to know what kind of emphysema I have?
A computed tomography (CT, also called a CAT or computerized axial tomography) scan of your lungs is used to determine how widespread the damage to your lungs is. CT is a high resolution, cross-sectional x-ray imaging procedure that allows doctors to see inside your body in great detail and examine the information in three dimensions (3D). If you have had a CT scan of your lungs then your doctors should be able to tell you if you have homogeneous emphysema - however you don't have to know this when you consider participation in the EASE Trial. One of the medical tests that is done after you sign the Informed Consent form is a lung CT.

Will it cost me anything to participate in the research trial?
No, if you are accepted to participate in this trial all study-related exams, treatments, and medical care will be provided at no charge to you.

Will I be reimbursed for parking and transportation?
Different study centers have different rules about reimbursement. Your study center will discuss this with you if you qualify to participate in this trial.

What are my chances of receiving the airway bypass treatment?
You have a two out of three chance of receiving the treatment. However, since the study is double-blinded you won't know if you received the airway bypass treatment until 12 months after the procedure.

Will hospitalization be required?
You will need to stay in the hospital for observation for at least one day after the bronchoscopy is done.

Who is the company responsible for this trial?
The company sponsoring this study is Broncus Technologies, Inc. located in California, USA. They have been studying similar procedures for the treatment of respiratory diseases in humans since 2001. The procedure being evaluated in this trial has been performed since July 2004 and was tested in a study that treated more than 35 people worldwide.

How big is the trial?
The first part of the trial will involve 45 patients at 15 sites. The trial is then expected to expand to more than 45 sites in the United States and around the world. There may be as many as 450 people in this study before it is finished.

How long will I be in the trial?
It is reasonable to expect that it will take about 15 months from the time you sign the informed consent form until the end of the first year of the study. If you are assigned to the treatment group, you will then be asked to return for evaluation once a year for the next four years.

What is pulmonary rehabilitation therapy?
Pulmonary rehabilitation is a multidisciplinary program of individualized education, supervised exercise training, nutritional therapy and lifestyle guidance that can help reduce shortness of breath and fatigue and increase exercise tolerance. It can also help prevent secondary conditions (such as muscle weakness and cardiac deconditioning) from developing.

Why do I have to undergo supervised pulmonary rehabilitation therapy?
The rehabilitation therapy will help get you ready for the study procedure.

Do I have to go to the study site location for supervised pulmonary rehabilitation therapy?
Depending on the study site, you may be able to go to a pulmonary rehabilitation center that is closer to your home than the study center.

Why is there a control group?
"Control" groups are traditionally used in clinical research to compare with the treatment group. The double-blind design of the trial with a control group helps address the potential for bias and contributes to obtaining scientifically valid results for the safety and effectiveness of the treatment.

What are the alternative treatments to the one being tested in the trial?
While emphysema and the resulting damage to the lungs are irreversible, there are some things that may help. Pulmonary rehabilitation therapy teaches, among other things, special breathing techniques. Other treatment options include bronchodilators and anti-inflammatory medicines. Many times supplemental oxygen is provided to patients with emphysema who have low blood oxygen levels. Lung transplant surgery
involves replacing one or both of the lungs with donor organs.

Are there any risks involved?
As with all medical procedures, there are risks involved. The known study risks are outlined in detail in the informed consent document. The consent process includes a discussion of these risks. Do not hesitate at any time to ask the medical staff conducting the trial to explain the risks to you.

What are the possible benefits?
As with all clinical trials, it is impossible to say if the treatment will help you. We cannot predict if you will receive the treatment. Even if you do receive the airway bypass procedure, there is no guarantee it will help you. We hope that you will find it easier to breathe afterwards and that your lung function and quality of life will improve. However, it is also possible that your breathing may improve for only a short while, that it may stay the same, or even get worse.

People in the control group will undergo a bronchoscopy, with no expected benefit. People in both groups may benefit from receiving additional medical care and the supervised pulmonary rehabilitation therapy.

Your participation is this trial will advance science and may lead to commercialization of the airway bypass procedure. By being part of this trial, you may help other individuals who, like you, are suffering from emphysema.

Should I talk to my doctor about this trial?
You can discuss your interest in this trial with your doctor and you should inform him/her if you are enrolled in the trial.

When can I stop my participation in the trial?
You can stop your participation in the study at any time. Ideally, you would tell the study center that you are ending your participation and the reasons why.

What are the risks of participating in this research trial?
As with all medical procedures, there are risks involved. The known study risks are outlined in detail in the informed consent document. Do not hesitate at any time to ask about the risks.

Who will have access to my name and the information you are collecting about me?
The screening information collected on this website is maintained by PhoneScreen. PhoneScreen will maintain your information for a period of 6 months after the study has completed enrollment. PhoneScreen will provide your information to the research site only with your permission. To learn more, please read PhoneScreen's privacy policy.

If you enter the study you will be identified to the study sponsor only by a number. The informed consent document outlines in detail how your information will be kept confidential.

What if I have other questions?
If you have other questions or information requests that are not addressed on this website you can call 866-488-EASE (3273) to speak to someone about your questions.