Why is AeroTrial being conducted?
Asthma is a chronic respiratory condition in which the airways may become narrow, swollen and irritated, and produce too much mucus. This airway narrowing may be triggered by exposure to something in the environment such as allergens, cold air, exercise or exertion, or emotional stress. Symptoms such as wheezing, shortness of breath, a feeling of tightness in chest, and coughing are common in asthma. When you have an episode of increased asthma symptoms that lasts for several days, it is called an asthma “exacerbation.” AEROVANT™ (AER 001 Inhalation Powder) is an inhaled dry powder that is being studied as a treatment for making the symptoms of asthma less severe and reducing the incidence of asthma exacerbation. The purpose of this research is to see if AEROVANT is safe and effective for use in asthma patients.

How long does my participation in AeroTrial last?
The estimated length of time you are involved is about 120 days, or about seventeen (17) weeks. This is from the time you are “screened,” or qualified for the study, until you are finished with the last follow-up visit.

What research tests are done during AeroTrial?
The main focus of this study is to determine if AEROVANT can improve the control that you have over your asthma symptoms and allow you to remove steroids from your treatment regimen. The tests that will be performed in the clinic will be centered on lung function measurement and assessment of your asthma symptoms. Other tests will be done to monitor safety. There will also be an optional blood sample for genetic testing to determine if some individuals benefit more from AEROVANT treatment than others. For a full list of tests and more details on the visit schedule please see trial process section or contact one of the sites near you for more information.

Who has access to my blood and genetic samples and information from the tests?
Laboratory safety and genetic tests are handled in a confidential manner, like other personal health information. The person collecting your sample, and people in the laboratory performing the test, will handle your sample. Your medical record and test results are confidential. Your written permission is required before your medical record is released to anyone else.

What drug will I take?
If you are eligible following all the screening procedures and tests, you will be “randomized” to either active study drug (AEROVANT) or placebo, which looks like the study drug but is not active. Randomization is like flipping a coin; you will be assigned by chance to either active study drug or placebo. In this study you have a 75% chance of getting the study drug and a 25% chance of getting placebo. Neither you nor your study doctor will know when you receive AEROVANT or placebo. This is called “blinding” and is important in order to keep the study results fair and objective. However, in the event of a medical emergency, the doctor can find out which treatment has been given to you at any point in time.

After screening, you will receive “switch-over medications” (salmeterol and fluticasone) to use to convert from your current combination asthma treatment. Most likely, you are already on salmeterol/fluticasone combination (i.e. Advair®) or something similar. The doses to start will be identical to the medication you are currently on. During the 4 week Stabilization period, you will add-on the study medication (AEROVANT or placebo). After the Stabilization period, your doctor will decrease the dose of your salmeterol and fluticasone over the course of a few visits. You will remain on the AEROVANT or placebo until visit 8.

What rescue medications am I given?
You are also given two asthma rescue medications as a safety measure in this study. You may or may not feel the need to use these but they will be provided to you just in case you do. You will receive a metered dose inhaler containing medicine called albuterol and a package of an oral steroid medicine called prednisone. You will be instructed to call your study doctor if your asthma symptoms get worse, or if you feel that occasional albuterol no longer controls your symptoms.

How is the drug given?
The AEROVANT study drug and placebo are dry powders administered using a small plastic device called a dry powder inhaler (tradename EZAer™ Inhaler) twice a day. You will need to put a capsule containing the drug into the inhaler, pinch some buttons on the side to pierce the capsule, then you inhale once. It's easy. It is similar to many other products currently on the market.

Will I have to keep a diary?
Yes, you will keep a daily diary that keeps track of your asthma symptoms. The diary is kept on an electronic hand-held device which is provided to you by your study doctor. You do not have to write down anything. You will be asked to record each time you took a dose of study drug, as well as your albuterol medication, in your electronic diary. Each time you visit the clinic, the diary information will be automatically transferred into a computer, and your study doctor will review the information.

The diary device also measures the strength of your lungs. Twice a day, you will be asked to blow into the device to measure the level of your lung function. The lung measurements are checked by your study doctor each time you visit the clinic.

Are there any risks?
AEROVANT has been tested in animals and humans. The drug has generally been very well tolerated. Any medical procedure has some risk, but study personnel will monitor you at all times while in the clinic and will be available by phone 24hours a day, 7 days a week. . You will be asked to reduce the level of steroid medication that you are currently taking once you are on the study medication for approximately 6 weeks. This may lead to an exacerbation of your asthma if the study medication is ineffective or if you are in the one fourth of patients that receive placebo. If you experience any problems, your study doctor may stop the treatment and give you the appropriate medicine for relief of your symptoms.

Will it hurt?
Obtaining blood samples may sometimes cause pain at the site where the blood is drawn, bruising, occasional lightheadedness or infection. There should be no other procedure in the study that causes discomfort.

What if I change my mind once I am enrolled in the study?
You may choose at any time to stop participation in the study. If you decide to stop, this does not affect your medical treatment or care.

Can I talk about the study with other people?
It’s natural to talk about the study with family, friends, or your family physician, but it is important that you do not talk to other study participants about your study experiences or theirs, especially what you or they may believe to be effects of the drug. This kind of talk could influence people and affect the unbiased collection of study data. It’s important to talk to study staff about any health changes you experience, even those changes you may not feel are important.

Do I have to give up my current medications?
Please inform your study doctor of all medications that you are taking for asthma and all other conditions. Your study doctor will explain exactly what medicines you can take and when you can take them during the course of this study.

During the study, you will be switched from your current long-acting beta agonist, or LABA, and inhaled corticosteroid, or ICS, medication to equivalent individual doses of a LABA called salmeterol and an ICS called fluticasone. Your asthma treatment will be gradually reduced over a period of 4 to 8 weeks. You will be carefully monitored during this time, and your study doctor will discuss this process with you.

What are the benefits to me if I take part in the study?
There may be no direct benefit from your participation in this study. Information from this study may help future asthma patients. It is possible your condition may not improve and may worsen while participating in this study.

Will I be reimbursed for my travel, time and efforts on the study?
Yes. You will be reimbursed for your travel, time, inconvenience, and efforts on study related activities.

The study drug (AEROVANT or placebo), rescue medication (albuterol and prednisone), asthma medications (salmeterol and fluticasone), study-related laboratory tests, examinations, and clinic visits performed as part of this study are provided at no charge to you.

Will my medical records and information be private?
Yes. Your information is not shared with anyone without your consent or as required by law. All personal information such as your name, address, phone number, or family physician’s name is removed from the data. If you participate in the study, you are identified only by your initials (in all countries except Germany) and a study number.

Where can I learn more about participation in clinical research trials?
There are some great resources available to learn more about volunteering for participation in clinical trials. We provide a few resources here for you (each link opens a PDF pamphlet).
- “A word from study volunteers”
- “Understanding the informed consent process”
- “Volunteering for a clinical trial”