The RhinoGen Study
The viruses that cause most common colds are rhinoviruses. Some rhinovirus colds are quite mild, while others include severe cold symptoms such as sore throat, cough, and stuffy nose. In children with asthma, rhinovirus infections are the most common cause of asthma attacks. The main goal of the RhinoGen study is to find out why some children have mild illnesses while others have severe colds or even asthma attacks when they catch a rhinovirus cold. Are there genetic factors that contribute the severity of illnesses with colds?
The purpose of this research study is to learn more about how genes are linked to colds caused by viruses in children with asthma and children who do not have asthma. We will also study how colds can make asthma worse. We will also ask questions about the things in home and school that could make a cold or asthma worse. The information gained from this study will be added to the knowledge that we already have from studying children in a research project known as COAST (Childhood Origins of ASThma). Approximately 400 children will participate in this study.
If you are interested in participating or leaning more, please click here for contact information.
|Allergy Skin Testing||X|
|Pulmonary Function Testing||X||X|
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|Diary Cards with Peak Flow Meter||X||X|
You will be asked to come to the University of Wisconsin Hospital and Clinics for two visits. At the first visit, we will get a sample of blood and we will ask you to do some breathing tests that use a computer. We will do a test for allergies on your arm. We will have you blow your nose into a baggie so that we can get a sample of the mucus. A doctor will examine you and your parent will answer some questions.
After the first visit, we will ask you to collect nasal samples 5 times in the fall and 5 times in the spring. A sample will be collected 5 Saturdays in a row for the five weeks that we ask you to do this. Samples will be collected by you, at home, in a ziploc baggie. You will also collect a nasal sample when you have a cold. You will put the baggie in a special container in your freezer until the study coordinators arrange to pick up the samples.
During the time you are getting the samples, you will use a "Peak Flow Meter" which is something that you blow through while holding this meter in your hand. This is a measure of your breathing and we will ask you to do this each day. You will write down your highest breathing test score each day. We will ask you to keep track of how you feel during these five weeks by using colored dots and putting them on a daily diary card. If you have a cold during the year, you will get an extra nasal sample from your nose and make extra notes on your diary card.
The second (and last) visit, one year after the first, will be at the University Hospital. At this visit you will repeat the breathing tests, a doctor will examine you and your parent will answer some questions.
Fourteen drops of different allergens will be placed on the skin of your arm with the sterile tool that will lightly prick the skin. The skin will be checked for a reaction to the allergens 15 minutes after the drops are applied.
RISKS: Your arm might itch or burn where the test was done and there may be mild pain from the needle scratch. In very rare cases, a whole body allergic reaction may cause shortness of breath, hives, swelling of the skin or tongue, itchy skin or a change in blood pressure. In order to be safe, we will observe you for 20-30 minutes after the test. Emergency care is available to treat these rare reactions.
The first test is called Exhaled Nitric Oxide (eNO). This test is done to measure the amount of inflammation or swelling in your lungs. This test just has you blow out three long breaths in to a tube. The second test is called Impulse Oscillometry Study (IOS). You will be asked to breathe normally into a mouthpiece that is connected to a machine that makes little popping noises while you breathe. This is measuring the size of your lungs. The third test is Spirometry. This test includes asking you to breathe really hard into a tube connected to a computer that measures the amount of air that you can blow out in one breath (like blowing out birthday candles). If you are able to complete several of these tests with the same effort, 2 puffs of albuterol will be given with a spacer and you will be asked to repeat the spirometry 15 minutes later. This is known as post-bronchodilator reversibility. This test is done to measure the improvement in the amount of air that you can blow out after taking medication that relaxes the muscles that are around your airways.
RISKS: There is no discomfort associated with the eNO, IOS, or Spirometry. In sensitive individuals, taking albuterol may make your child's heart race, make them feel jittery or nervous, can increase blood pressure, or cause nausea or headache. However, these symptoms usually go away in less than an hour. If you have a cold or pneumonia, we will ask to do the visit at another time because the breathing tests will not be accurate for you. Therefore, we will never ask you to hold medicines during a time that you are sick. We will also never ask you to "skip" a breathing medication, but may ask you to wait to take it until after the breathing test is completed. Specific instructions will be given for your situation.
A sample of blood will be obtained at visit 1 in order to study how your body reacts to viruses. We will study if your reaction to the virus is different if you have asthma or if you do not have asthma. Approximately 35cc (2 tablespoons) of blood will be obtained from you. Medicine is put on your skin, at both elbows, that numbs the skin to reduce any pain from having the blood draw done.
Blood samples will be stored in a very cold freezer (-80 degrees) so that samples can be kept and used until the end of the study. Results of some tests will be available to you (e.g. RAST testing, which is an allergy sensitization seen in the blood). However, results of these tests would have to be repeated to be confirmed as the research laboratory is not certified as a clinical laboratory. There are also other tests being done that will not be available to you because "normal" values are not yet known or understood.
RISKS: Drawing blood from a vein may cause discomfort, possible bruising or swelling at the place where the blood is drawn. On rare occasions, a minor infection may result from this procedure. Possible side effects of the numbing medication include paleness, redness, mild swelling, itching, and rash at the application site. However, these effects are rare with the use of this topical medication due to the small dose absorbed.
Nasal mucus is collected at the first study visit, and each Saturday during five weeks in the fall and five weeks in the spring. The "nasal blow" procedure will be taught to you and your parents at the first study visit. We will deliver the equipment to your home right before you need it since some of the fluids in the tubes cannot be stored for very long.
You will get the samples on (or very near) the date asked of by the study coordinators. After you do the "nasal blow", you will be asked to freeze the samples in a container that we give you by putting it in your freezer. We will also ask you to collect a sample if you get a cold or a worsening of your asthma during the year of this study. The study coordinators will make arrangements to pick up these samples from your home or a place that is convenient for you.
Samples will be tested for viruses and to help us learn more about how genes and viruses relate to asthma.
RISKS: There is unlikely to be any risk associated with the nasal blow into the ziploc baggie. However, if you have a dry nose or a recent bloody nose, you might produce bloody mucus. You may not like the feeling of having wet mucus on your nose as a result of blowing into a ziploc baggie.
Peak Flow Meter Readings: You will be asked to complete peak flow readings each day during the nasal sample collection and record your highest peak flow reading on the diary card. A Peak Flow Meter is a "take-it-with-you", hand held device used to measure how air flows from one's lungs in one fast blast. Using the meter is as simple as taking a deep breath and blowing out. You will be able to keep the Peak Flow Meter at the end of the final season for future use.
RISKS: A Peak Flow Meter is not a medicine. Sometimes pushing the air out of your lungs in a "fast blast" may cause you to cough or wheeze.
Diary Cards: During the time that you are getting samples of nasal mucus, you will also be asked to keep a diary. Each day on this diary you will write down the highest number from the Peak Flow test, and then use stickers to mark whether you have a cold or if your asthma is bad and whether you have to use any medicines for your asthma. You will start the diary one week before the first nasal blow, do it for five weeks during the nasal blows, and then one week after the last nasal blow.
RISKS: There is unlikely to be any risk with the completion of the diary cards.