* The determination of which test will be conducted will be based on the child's ability to complete spirometry and the status of your child's pulmonary function at the time of the test.

** Nasal Mucus Samples will also be collected at the time of wheezing and/or lower respiratory infection.

*** A brief phone call will be made 6 months after the annual visit to complete a questionnaire assessing respiratory symptoms and updating personal data.

Explanation of Study Procedures with Risks

Pulmonary function testing:

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 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.

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Plethysmography

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. You will take normal breaths, until the study coordinator tells you to take two quick breaths, and then one really big breath in and a long but not a forceful breath out. This test 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 at any point if you want to.

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Sputum Induction:

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.

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Allergy Skin Testing:

You will have allergy skin testing 2 times during COAST III, once at age 9 and again at age 13, approximately near completion of puberty. Fourteen drops of different allergens will be placed on the skin of your back 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 back 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.

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Blood Draws:
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. (Consent for genetic testing was obtained with a separate consent and your family may have decided not to participate in this test.) 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.

Blood samples will be maintained into the future to be used throughout this study until the sample is gone. Blood sample testing will be completed at the UW and some of the sample may be shared with an outside researcher to perform a specific test not being completed at the UW. The sample will be sent only with information critical to the illness history.

For families who move (or already have moved) out of the greater Madison area, we can continue to get a sample of blood from you. We will work with your parents to identify a laboratory where the blood draw can be done. The family will go to the clinic for the blood draw procedure, receive the blood from the clinic and then take the pre-paid shipping box to the drop-off location for shipment to the UW. The COAST staff will arrange for the blood draw, provide the equipment, and pay for the blood draw.

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.

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Nasal Mucus Sampling

Nasal mucus samples will be collected by the "blowing" method that you have learned over the past several years during regular study visits and during periods of illness. Normal saline (watered down salt water) will be squirted into each nostril and you will be asked to blow your nose into a plastic zip-loc baggie. The image to the left shows the collection of nasal secretions into the inside of a plastic baggie.

We will ask your parents to call the study center when you have symptoms of a cold with a runny nose, cough, fever, or wheezing, or when you need to "step-up" on your asthma action plan. We will continue to track all respiratory infections or colds, and will collect a sample at that time. Samples will be tested for factors that will help us learn more about the development and course of allergies and asthma. Nasal samples are maintained throughout the COAST study for testing.

For families who move (or who already reside) out of the greater Madison area during the course of the study, continued participation in this part of the research study is encouraged. As all families are involved in collecting samples, continued participation is possible. Families would be asked to contact the COAST staff when you are ill (a toll-free number is provided). The COAST staff would verify the need to obtain a nasal sample and then would provide all required materials and a pre-paid mailer for sending the sample to UW. Instructions for the procedure will be in both oral, written and photo form.

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: You will be asked to complete peak flow readings each day for about a week following 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 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 "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.

To see a sick diary card, click here.

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

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Questionnaires:

We also will collect the following health information about you for this research study in the form of questionnaires:

• Child health and medication history questionnaires
• Familial history of allergy and asthma, parental incidence of allergy and asthma, and parental height and weight. (parental information is used to make familial comparisons)
• Environmental overview relative to allergen exposure
• Two “Quality of Life” questionnaires which discuss: 1.) general health of the child, and 2.) child's health relative to asthma.

Click here if you'd like to be directed to our online questionnaires.