COAST + Study
60 Additional Subjects
This study is linked to the COAST (Childhood Origins of ASThma) study, which has been following 257 children prior to birth. The purpose of this research study is to learn more about how viruses are related to asthma, especially as children grow into teenage years and enter puberty. This study will begin before puberty is entered and will last until one year after the achievement of puberty.
In order to be eligible, all participants need:
- To fall into the same range of birth dates as the original COAST children (5/1998 - 11/2000).
- A previous diagnosis of asthma.
- At least one of the parents need to have allergies, asthma, or both.
If you are interested in participating or leaning more, please click here for contact information.
As part of COAST +, all subjects will completed the same yearly procedures as the COAST children.
Age of Child
|Age 8||Age 9||Age 10||Age 11||Age 12||Age 13|
|Allergy Skin Testing||X||X|
|Pulmonary Function Testing||X||X||X||X||X||X|
|Physical Exam - Child||X||X||X||X||X||X|
|Child and Parent Questionnaires||X||X||X||X||X||X|
|Nasal Mucus Sample**||X||X||X||X||X||X|
Explanation of Study Procedures with Risks
Your child will have Pulmonary Function testing (PFT) annually. There will be several types of tests completed at each visit. The tests can be stopped at any time if you or your child begins to feel uncomfortable. For families who move (or already reside) out of the greater Madison area during the course of the study and decide to continue in the study extension, these procedures will not be performed. Some medications, some foods and a recent respiratory infection can affect the results of these tests. We will talk to your family specifically if there is any need to wait to take a medication until after the test, or to wait to eat food until after the testing is completed or to reschedule if your child has had a recent cold or illness.
We will also be testing Post-Bronchodilator Reversibility. This is when we admisiter albuterol and complete the IOS and Spirometry again. The image to the left depicts a boy taking albuterol and using a spacer. This helps us see if albuterol improves lung function.
1) Exhaled Nitric Oxide (eNO) starts with taking a deep breath through a tube, followed by a medium, even blowing out into the tube. This test measures the amount of Nitric Oxide that is exhaled. Nitric Oxide is believed to be higher in the lungs if you have allergies and/or asthma.
2) Impulse Oscillometry (IOS) is a test where you breathe normally through a tube and a gentle puff of air is blown into their mouth. This test is one method of measuring if it is hard for air to get in to your lungs.
3) Spirometry is the test where you take a deep breath and then blow out as long and hard as possible into a mouthpiece. We will ask you to do this up to eight times.
RISKS: There is no discomfort associated with the eNO, IOS, or Spirometry. In some people, taking albuterol may make their heart race, make them feel jittery or nervous; can increase blood pressure, or cause nausea and/or headache. However, these things usually go away in less than an hour.
At age 9 and 13, you will be asked to sit in a small clear room about the size of a small closet or telephone booth. This test helps us measure lung volumes. It is repeated as many times as needed to complete the test or until you do not want to continue or up to the time limit of 30 minutes. The image to the right shows an adult performing plethysmography.
RISKS: There is no discomfort associated with Plethysmography. Possibly you may not like being in this small room (claustrophobia), but the box is made of clear plastic, which allows you to see your parents and everything in the room. You can also stop the procedure if you want to.
This is a procedure to obtain some mucus or phlegm from low in your lungs. For the Sputum Induction test at age 10 and 13, you will inhale or breathe in a mist of concentrated salt water through a mouthpiece for up to 12 minutes. You will be asked to stop every 4 minutes, blow your nose, and rinse, gargle with water and spit into a cup. Then you will be asked to cough really hard to get some of the mucus from your lower airways and spit it into a collection cup. We will do a breathing test (peak flow meter) every 4 minutes as well to make sure that the salt water is not changing your breathing. The entire procedure takes about 45 minutes.
RISKS: There is little discomfort associated with Sputum Induction. Some symptoms that you may have with the concentrated saltwater test are a salty aftertaste, sore throat, or feeling tired. During this procedure, it is natural to feel like coughing but we will ask you not to cough or clear your throat except when we ask you to. Because you are trying to hold your cough, this might make you feel uncomfortable. On rare occasions, shortness of breath, wheeze, lightheadedness, nausea and/or headache may occur.
You will have allergy skin testing 2 times, once at age 9 and again at age 13. Fourteen drops of different allergens will be placed on the skin of your arm with a 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 sharp scratch from the tool. 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 fall in blood pressure, and so we will check you for 20-30 minutes after the test. Emergency care will be available to treat these rare reactions.
Blood samples will be obtained annually from your child in order to evaluate for possible immunologic and genetic factors that influence the development of asthma. About 3 tablespoons (50cc) of blood will be drawn from your arm. The blood samples will be obtained from a vein in your arm and a numbing medicine will be used on the area where the blood will be drawn.
RISKS: Drawing blood from a vein may cause discomfort or soreness and possible bruising or swelling at the spot where the blood is drawn. Rarely, a minor infection may result from this procedure. Possible side effects to the numbing cream include paleness, redness, mild swelling, itching, and rash. However, this is rare because a very small amount of cream will be used.
Nasal mucus samples will be collected by blowing your nose into a plastic baggie, both during regular study visits and during periods of illness. Normal saline (salty water) will be squirted up each nostril to obtain this.
RISKS: There is unlikely to be any risk associated with the nasal blow into the baggie. However, if your nose is dry or if you have had a recent bloody nose, you might have bloody mucus. You may not like the feeling of having wet mucus on your nose as a result of blowing into a baggie.
Peak Flow Meter Readings will be completed each day for about a week following the nasal sample collection. You will 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 a candle. You will be able to keep the Peak Flow Meter.
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: For about a week after you have gotten a nasal sample you and your parents will also be asked to use sticker "dots" to keep a diary of your symptoms. The diary includes: writing down the highest Peak Flow reading for each morning, choosing a colored dot that shows what symptoms of a cold or asthma you have, placing the dot on the card and writing down if you use albuterol.
In summary, when your child has cold symptoms lasting two days, we will request that you do the following:
• Contact the study center
• Collect a nasal sample.
• Record symptoms with the "dots" on the diary card during the days of the illness
• Obtain a peak flow reading each morning and record this number on the diary card.
• Send the sample and the diary in the self addressed mailer tube
RISKS: There is unlikely to be any risk with the completion of the diary card