Emory University IRB
IRB use only / Document Approved On: 9/5/2012Project Approval Expires On:8/7/2013
Emory University
Consent to be a Research Subject
Version Date: July 24, 2012
Title: TheSevere Asthma Research Program (SARP) 3
Principal Investigator: Anne M. Fitzpatrick, PhD
Sponsor: National Institutes of Health (NIH), National Heart, Lung and Blood Institute (NHLBI)
Note: If you are the legal guardian of a child who is being asked to participate, the term “you” used in this consent refers to your child.
Introduction
You are being asked to be in a medical research study. This form is designed to tell you everything you need to think about before you decide to consent (agree) to be in the study or not to be in the study. It is entirely your choice. If you decide to take part, you can change your mind later on and withdraw from the research study. The decision to join or not join the research study will not cause you to lose any medical benefits. If you decide not to take part in this study, your doctor will continue to treat you.
Before making your decision:
- Please carefully read this form or have it read to you
- Please listen to the study doctor or study staff explain the study to you
- Please ask questions about anything that is not clear
You can take a copy of this consent form, to keep. Feel free to take your time thinking about whether you would like to participate. You may wish to discuss your decision with family or friends. Do not sign this consent form unless you have had a chance to ask questions and get answers that make sense to you. By signing this form you will not give up any legal rights.
A description of this study is available on as required by U.S. law. This Web site will not include information that can identify you. At most the Web site will include a summary of the results. You may search this Web site at any time. The number for the study is NCT01606826.
Study Overview
You have been invited to join in a research study. This is a research study that is being done to learn more about severe asthma by comparing people with severe asthma to those with milder forms of asthma over time. You are being asked to join a research study to follow your overall health and the health of your lungs for up to three and a half years. In this study, we will look at your breathing tests, your level of irritation in your blood and breath, the number of and how bad your asthma attacks are, your medication use and other conditions related to asthma over time. About 700 subjects will be enrolled in this study across all centers. Up to 100 children will be enrolled at Emory University.
What Is the Purpose of This Study?
The job of the Severe Asthma Research Program (SARP) is to improve the understanding of severe asthma to develop better treatments. The SARP will gain a better understanding of asthma, in children and adults, by looking at the disease level in a very detailed way. You are being asked to join in this study because you have asthma.
Who is Sponsoring the Study?
Emory University is one of seven research groups, funded by the National Institutes of Health, to work together to study severe asthma. This group of sites is part of the SARP. Because severe asthma is uncommon, the centers were set up to work together to enroll enough people with severe asthma in research studies. Each of the centers will conduct a common longitudinal protocol and will share the information, test results and research samples collected across all seven centers. If you decide to join this research study at the Emory University, you will also be asked to allow the sharing of your study information and samples with other sites participating in this study.
What Does this Study Involve?
This study will last up to three and a half years and will involve up to eight clinic visits, and at least eight phone or mail contacts from research study staff. A detailed study grid is shown here. An explanation of each procedure can be found below.
Visit number / Visit 1 / Visit 1a** / Visit 2 / Visit 3 / Phone call 1 / Visit 4 / Phone call 2 / Visit 5 / Phone call 3 / Visit 6Timeline
Procedure / enroll / Day 2-13 / Day 14 / Day 32 / Month 6 / Month 12 / Month 18 / Month 24 / Month 30 / Month 36
Medical history / X / X / X / X / X / X / X / X / X / X
Asthma history / X / X / X / X / X / X / X / X / X / X
Questionnaires / X / X / X / X / X / X / X / X / X
Urine collection / X / X / X / X / X / X / X
Physical exam / X / X / X / X
Spirometry / X / X / X / X / X / X
Maximum bronchodilator response / X / X / X / X / X / X
Exhaled nitric oxide / X / X / X / X
Exhaled breath condensate / X / X / X / X
Sputum induction* / X / X / X
Blood draw / X / X / X / X
Triamcinolone injection / X
Methacholine challenge* / X
*Will only be completed in children 12 years and older
**Will not be completed in all children
SARP Registration:
Before you enroll in SARP, you must first be entered into the SARP Registry. This Registry has been set up to collect basic background information that will probably not change over time. This information is limited to: your initials, date of birth, gender, and race/ethnic identification. Your Registry information will be coded with a unique SARP identification number. No information that directly identifies you will be entered into the SARP database or sent to the Data Coordinating Center (Penn State University, Hershey, PA). Registry data help us track your study over time and is useful in data analyses.
Your agreement to provide the information for the SARP Registry is voluntary. However, if you choose not to provide it, you cannot be screened for or enrolled into SARP. Once you consent to be entered into the Registry, your information cannot be removed and will be maintained in the study database into the future. You will only be asked to supply Registry information one time during your participation in SARP. Registration happens before or during your first study visit (Visit 1).
Study Procedures
During this study, the following procedures will be performed:
Medical history: We will ask you detailed questions about your past and present medical and surgical history.
Asthma history: We will ask detailed questions about your asthma and allergy symptoms.
Asthma questionnaires: There will be several questionnaires that you will fill out or that the study staff will fill out as you respond to questions. There are no wrong answers to these questions.
Urine pregnancy test: You will provide a small amount of urine on all visits for urine pregnancy testing if you are a female of childbearing potential to make sure you are not pregnant before taking any study medication or doing some study procedures. You will not be enrolled if you are pregnant or breastfeeding. If you become pregnant during the longitudinal follow up phase, we will ask that you let us know.
Urine for lab studies: Urine will be collected to look at signs of inflammation that might be related to asthma.
Physical exam: The study investigator will listen to your heart and lung, and look at your eyes, ears, nose and throat. Vital signs (blood pressure, temperature, height and weight) will also be done at these visits. The study personnel will also perform an exam of pubertal development. This involves having one of the study personnel looking at your private areas to determine your stage of puberty. It is important to understand how these changes with puberty affect aspects related to your asthma. There will be one other hospital or study personnel present as a chaperone. To make sure we do not miss any of these changes, this exam will be done every 12 months until you have reached the final stage of puberty.
Spirometry: You will be asked to take a deep breath in and blow your breath out as hard and fast as you can into a machine for at least 6 seconds. This machine measures the amount of air you have in your lungs and how well you can blow the air out. We have you do this 2 or 3 times so we can get an accurate measure of your lung function. This will be measured at each clinic visit.
Maximum bronchodilator response:You will do spirometry and then take 2 puffs of albuterol. 15 minutes later you will do spirometry again. You will continue to take another 2 puffs of albuterol with spirometry measured 15 minutes later until you no longer get any better. For this test you will receive no more than 8 puffs of albuterol.
Exhaled nitric oxide (ENO): Nitric oxide is a gas that is released from inflammatory cells in the lung. You will gently blow air out into a machine for a 10 second period of time.
Exhaled breath condensate (EBC):You will be asked to put on nose clips and put a mouthpiece in your mouth. You will breathe normally for 10-15 minutes. At the end of that time you will remove the mouthpiece and the nose clips. If you cough, sneeze or feel saliva collecting in your mouth during the test you will be asked to stop and remove the mouthpiece. After you cough, blow your nose or spit out saliva you may put the mouthpiece back in your mouth and continue to breathe normally until the end of the collection time. While you are breathing normally the air you breathe out is cooled and forms a liquid that drips into a collection container. The sample is frozen and analyzed at a later date.
Sputum Induction: This is a procedure for obtaining some mucus or phlegm from your lower airways, if you are 12 years of age or older. Before the procedure you will be given 4 or more puffs of an albuterol inhaler to protect against bronchospasm (tightening of the bronchial tubes). You will inhale a mist of salt water through a mouthpiece for about 12 minutes. You will be asked to stop every2 minutes, , and rinse and spit with water. Then you will be asked to cough up some of the mucus from your lower airways and spit it into a collection cup. We will check your lung function after every 2 minutes to make sure it hasn’t decreased. This procedure takes about 45 minutes. This procedure will be done at Visits 2,3 and 4.
Blood draw: We will draw just over two ounces or four and a half tablespoons of blood. The area inside your elbow will be wiped down with alcohol prior to placing the needle in the vein. Part of the blood drawn at Visits 2 and 3 will be for genetic sampling and is described in more detail below. The other blood that is drawn throughout the study is to look at the numbers and types of cells in your blood.
Triamcinolone acetonide treatment: At the end of Visit 2, you will be given a shot of Triamcinolone acetonide that will be adjusted to your body weight. This will be given as a single shot into your butt. Triamcinolone acetonide is a steroid medication that is approved by the FDA for the treatment of inflammation in people with asthma. The purpose for this treatment is to allow the researchers to look at different measures of inflammation before and after you receive the steroid treatment to see if there are any changes. The dose of this medicine is within the safe range. You will continue your usual asthma medications throughout the study.
During this study, the following procedure might be performed if required:
Methacholine challenge: Methacholine is a chemical that can cause the airway tubes to tighten and can act like asthma symptoms. People who have asthma have airways that are sensitive to smaller amounts of methacholine than people without asthma. This test measures how sensitive your airway tubes are to the methacholine. We will measure your lung function. You will be asked to breathe in 5 inhalations of methacholine, starting at a very low amount. This will be given through a nebulizer. Your lung function will be measured 3 minutes after each amount of methacholine, if your lung function has not decreased by 20% the amount of the next dose doubles. The challenge will be stopped when your lung function measurements have decreased 20% from your baseline or you receive the highest amount we are using. This takes approximately one hour. This will be done once if needed. If you have previously participated in an NIH study involving methacholine, you may not need to complete this procedure.
Risks and Discomforts
Asthma questionnaires: The questionnaires are not tests; there are no “right” or “wrong” answers. There are no known risks to answering the questionnaires. The questionnaires might be considered long with repeating questions. You can skip any question you feel uncomfortable answering.
Holding asthma medication: For some visits, the study staff may ask you to not take your asthma medication before the visit. If your asthma symptoms get worse and you feel that you need to take your medication, please take your asthma medicine and call the study staff to let them know.
Urine collection: There are no known risks for the collection of urine.
Spirometry: During spirometry you may feel short of breath. If this occurs and does not go away on its own you may be given puffs of an albuterol inhaler.
Maximum bronchodilator test: You might have coughing or lightheadedness with spirometry. You will get up to 8 puffs of albuterol for this test. Taking up to 8 puffs of albuterol can make your heart race, make you feel jittery or nervous, can increase your blood pressure, cause nausea or headache. These feelings are temporary.
Exhaled nitric oxide (ENO): ENO is a breathing test with no known risks.
Exhaled breath condensate (EBC): There are no known risks to this procedure. It is noninvasive. It is possible you may start to feel resistance when you exhale if the liquid freezes before it drips into the sample collection container. If you feel this resistance you may stop. We will then warm the frozen liquid to allow it to drip into the collection container. After that you can go back to breathing through the machine to complete the collection time.
Sputum Induction: You may experience a salty after taste in the mouth, coughing, a feeling of needing to swallow, a sore throat, shortness of breath, wheezing, chest tightness, lightheadedness, nausea or headache. In rare cases, some patients have had a severe asthma attack or a reaction to the salty water that they breathe in. Albuterol treatment will be available if this occurs.
Blood draw:You may experience some pain or bruising where the needle enters the skin. You may also feel faint or sick to your stomach while having your blood drawn. There is a rare risk of infection where the needle enters the skin.
Triamcinolone acetonide treatment: Side effects with this steroid are not very common. However, side effects of a shot in your muscle have been reported, including atrophy (a “dimple”) at the injection site and changes in skin color. These side effects are kept low by placing the drug deep into the muscles. All triamcinolone shots will be given by an experienced member of the study staff. Side effects in the body after a single shot of triamcinolone are rare. However, with continuous or repeated use, muscle weakness, bone fractures, ulcers, impaired wound healing, and growth suppression may occur. To lower these risks, you will be screened thoroughly by a physician for the likelihood of side effects before the shot is given. We will tell you what problems to look for and we will call you within 72 hours to make sure that you are OK. Also you will have 24-hour access to an on-call physician while you are participating in this study.
Risk of disclosure:Your research samples and data will not be labeled with your name or other items that might identify you. All data will be stored in a password protected, study specific database and will be labeled with a code number. There will be very limited access to the link between your name or other personal information and the study code. Because this link will exist, there is a small risk that your name may become known in association with this research study.
Methacholine challenge: During this procedure you may experience asthma symptoms such as shortness of breath, wheezing, tightness or cough. You will be given several puffs of an albuterol inhaler for relief of symptoms. The symptoms are usually gone within a few minutes after using the medication.
There may be side effects from the study procedures that are not known at this time.
If you are a woman: to protect against possible side effects of the study drug, women who are pregnant or nursing a child may not take part in certain parts of this study. If you are a woman of childbearing ability, you will be tested for pregnancy at each study visit. If you think that you have gotten pregnant during the study, you must tell the study doctor immediately. Pregnant women will be allowed to complete some parts of the study, such as questionnaires, but not other parts. The study investigator will discuss these with you.