Frequently Asked Questions

What is Asthma?
What do normal and asthmatic airways look like?
What happens when your airways (or breathing passages) are narrowed?
How is asthma currently controlled?
What is the AIR2 research study about?
What is Bronchial Thermoplasty?
What is the Alair® System?
What potential benefits does this research study offer you?
How has the Alair® System been tested?
What are the risks of Bronchial Thermoplasty using the Alair® System?
How much time will it take?
What support will I have?
Can I change my mind later?
Who else is doing this?
How do I get involved in the AIR2 Trial?

What is Asthma?
Asthma is a chronic condition of the airways in the lung. Symptoms are usually variable; at times they occur and at other times they improve or may disappear. The airways become more sensitive and easily narrowed by certain factors called triggers. Triggers can be different for different people, and can include allergens, irritants, exercise and infections.

What do normal and asthmatic airways look like?

What happens when your airways (or breathing passages) are narrowed?
In asthmatic airways, there is an increased thickness of the muscle called airway smooth muscle which circles the airways. Narrowing of the airways is caused partly by contraction of airway smooth muscle and partly by swelling and secretions. When the airways narrow you may feel shortness of breath, chest tightness, wheezing, and cough.

How is asthma currently controlled?
Identifying and avoiding or reducing exposure to triggers or things that cause asthma to worsen is a first step. Additionally, taking medications regularly may help to control your asthma. Medications can include:

• Relievers (bronchodilators) that relax the smooth muscle that surrounds the airway. Relievers include short-acting relievers that may last 4-6 hours and long-acting relievers that may last 8-12 hours.
• Controller (corticosteroids) that control inflammation over time.

What is the AIR2 research study about?
The AIR2 Trial is no longer enrolling patients.
The AIR2 Trial will study the safety and efficacy of a new investigational outpatient procedure called Bronchial Thermoplasty using the Alair® System for the treatment of severe asthma. You will first participate in a number of screening tests to see if you qualify for the study. You will also be assessed to make sure you are on the correct medications to keep your asthma under control.



If you meet all of the study criteria and choose to participate, you will be randomized to either a Treatment Group or a Control Group. There will be two Treatment Subjects enrolled for every Control Subject. This means you are twice as likely to be placed in the Treatment Group as in the Control Group. The Control Group will continue to take their prescribed medications throughout the study, and they will undergo three outpatient diagnostic bronchoscopy sessions. These bronchoscopy sessions will not include treatment with the investigational device.

Bronchoscopy is an examination that allows a doctor to see inside your airways. During bronchoscopy, a flexible tube called a bronchoscope is used to transmit images of your throat and lower bronchial airways of your lungs. The Treatment Group will also continue to take their prescribed medications throughout the study, but will also have their airways treated during the three bronchoscopy sessions with a new investigational, outpatient procedure called Bronchial Thermoplasty with the Alair® System.

What is Bronchial Thermoplasty?
Bronchial Thermoplasty is an investigational procedure that utilizes the Alair® System to heat the lining of your airways in a controlled manner. This procedure is designed to keep the airways from narrowing by preventing the airway smooth muscle from contracting (similar to the effect of the reliever medications).

What is the Alair® System?
The device consists of a small flexible tube with an expandable wire basket at the tip. It is placed through a standard flexible bronchoscope through the mouth or nose, so that no incision is required. Once the treatment is completed the device is removed.

What potential benefits does this research study offer you?
The AIR2 Trial is no longer enrolling patients.
You will have the opportunity to learn more about your asthma. You will be closely monitored and have multiple clinic visits with an asthma specialist. It is possible that you will receive no benefit from the treatment or any benefit that you experience may be temporary. This treatment may have the benefit of reducing the amount of medication you have to take every day at the end of the study. This treatment may reduce the number and or severity of asthma attacks. The effect of this new procedure may persist - possibly for two years or longer.

How has the Alair® System been tested?
This device has been used in 16 patients with asthma who were enrolled in a safety trial at two asthma centers in Canada. Two years following their last treatment, the 16 patients on average showed less airway narrowing after stimulation with a drug that causes contraction of airway smooth muscle. All patients surveyed indicated that they would definitely or probably undergo the Bronchial Thermoplasty procedure again, knowing now what the procedure involves. In previous clinical studies conducted outside the US,(e.g. Canada, Brazil and Europe), more than 255 treatment bronchoscopies have been performed with this device in 86 patients with moderate to severe asthma. Of these patients, all 86 are at least 24-months post-treatment as of October, 2006.

What are the risks of Bronchial Thermoplasty using the Alair® System?
With any bronchoscopic procedure, there is the possibility of fever, bleeding, spasm, irregular heartbeat, shortness of breath, increased mucous secretion, or infection. There is also the possibility that you may experience wheezing, coughing, or shortness of breath during the first few days after each procedure. The known study risks are outlined in detail in the AIR2 Trial informed consent. Ask the study coordinator and/or the principal investigator (physician) to explain these to you in more detail. You will be monitored closely through this study to ensure that you receive appropriate medical care.

How much time will it take?
The AIR2 Trial is no longer enrolling patients.
This is a one year study involving approximately 15 visits. We realize this is a major imposition on your time but this investigational new treatment needs proper and thorough evaluation. The majority of these visits usually take 1-2 hours. Patients will be scheduled for a bronchoscopy session on 3 of those 15 visits. This outpatient procedure allows you to be in and out of the hospital the same day.

What support will I have?
Your study coordinator and principal investigator (physician) are always available to assist you with any questions you may have. You will be given all the materials you will need to assist you in remembering appointments, when to take or not to take certain medications, etc. All of the medical tests included in this study are paid for by Asthmatx.

Can I change my mind later?
Absolutely. You are free to withdraw from the study at any time. This decision will not affect your future medical care.

Who else is doing this?
About 300 patients will be enrolled in this study. This is an international, multi-center trial, so not all patients will be at your institution. About 35 centers throughout the world are expected to participate in this study. Due to confidentiality, names and phone numbers of other patients cannot be supplied.

How do I get involved in the AIR2 Trial?
The AIR2 Trial is no longer enrolling patients.
If you have asthma, are between 18 and 65 years of age, are a non-smoker, and take medication daily to control your asthma, you may be eligible to participate in this study. For more information on participation in this study please call 866-400-AIR2.

For more detailed information, please visit the AIR2 Trial listing on ClinicalTrials.gov

Thank you for considering this important new research
for the treatment of asthma.