30 Bond Street

                                                                                                  Toronto, Ontario

                                                                                                  M5B 1W8

 

                                                                                                                                                                                 A teaching hospital

                                                                                                                                                                                 affiliated with the

                                                                                                                                                                                 University of Toronto

Name: _____________________________________

 

Date of Birth: _______________________________

 

 

·        Title of Study

Respiratory Inflammatory Response to Ozone Exposures in Asthmatic Children/Adolescents

Short Title: The Ozone Study

 

 

·        Investigator

Dr. Barry Zimmerman, MD, St. Michael's Hospital Research Centre

Phone: (416) 921-6868 (Monday to Friday 9:00-5:00)

 

 

·        Why are we doing this study?

When you are outside, you breathe the air pollutant ozone, made from car exhaust fumes and sunlight.  First, we would like to find out if children who breathe ozone (like in the outside air) while pedaling on a bicycle in a research lab, feel worse than on another day when they are breathing clean air with no ozone.  Second, we would like to know if breathing ozone feels worse for children who have asthma, compared to children who do not have asthma.  Third, we would like to know if breathing ozone feels worse in children who have asthma and allergies to a house pet.  The test results could be useful for asthma doctors when choosing what type of asthma medications to give their patients, to make them feel better, faster.  Also, the information could be used by the government to decide what levels of ozone in the outside air are safe to breathe.

 

 

·        What will happen during the study?

Six non-smoking children, 7-18 years of age, who have asthma and allergies to a house pet, but are not taking the asthma medication Flovent, Beclovent, or Pulmicort, in the last month, will come to the Gage Occupational and Environmental Health Unit (Gage) for the ozone study.  The following non-smoking children 7-18 years of age will also come to the Gage for the same tests: six children who have asthma and are taking the asthma medication Flovent, Beclovent, or Pulmicort; six children who have asthma and no allergies to a house pet, and are not taking the asthma medication Flovent, Beclovent, or Pulmicort, in the last month; and six children who do not have asthma. 

 

If you use the asthma medication Ventolin, then you must not use it for 12 hours before your Gage visit, that is from 9 p.m. the night before.  However, if after 9 p.m. your asthma gets worse and breathing is difficult, you may take your Ventolin if necessary, although you should contact Dr. Barry Zimmerman at 416-921-6868 before coming to the Gage. 

 

On your first visit to the Gage, it will take about three hours and you will:

·        be asked questions about your health, with your parents help

·        have a medical examination by one of the study doctors

·        do tests to see if you can come for the rest of the ozone study

·        practice the tests that we will be using in the study

 

The tests include:

·        breathing tests

·        spraying a salty mist into your nose

·        pedaling on a bicycle that is on a stand

·        breathing in a salty steam to make you cough up some sputum

·        taking about one tablespoon of blood from your arm

·        an allergy test to see if you have allergies to things you breathe in the air, such as grass, ragweed and others that are commonly tested for.

14 small drops will be placed on the underside of your forearm, then a small prick will be made with the tip of a needle at each drop. 

If you have a reaction, you will get a small raised reddened area within 10 minutes at the drop(s), but it will start to disappear after 10-20 minutes.

·        a blood pressure measure with an arm band

·        a heart test using an electrocardiogram or E.C.G. machine. 

 

If we look at your test results and want you to come for the rest of the ozone study, you will come to the Gage three days in a row for 90 minutes the first day, four hours the second day and two hours the third day.  Two weeks later or longer, you will come back to the Gage and repeat the three-day tests. 

 

The following are the tests that you will do on the three days: 

·        On the first day, you will do a breathing test and the sputum test 

·        On the second day, you will first have breathing and nasal tests, and have a sample of blood taken.  Then you will sit in room will see-through walls for two hours, pedaling on a bicycle for 15 minutes, four times, with a 15 minute rest in between.  While in the room, we will record your heart rate with a heart test, and every 30 minutes you will also do some breathing tests.  When you come out, you will be asked about any symptoms you had, such as dry throat or cough, then you will have breathing, nasal and sputum tests, and have a sample of blood taken. 

·        The next day you will be asked about any more symptoms you had, then have the breathing, nasal and sputum tests and have a sample of blood taken. 

 

During the two hours that you are in the room, we will add ozone to the air on one of the visits, and clean air with no ozone on the other visit.  The amount of ozone will be about the same as the highest ozone day in the summer.  We will pick whether you get ozone first or second, and you will not be told which was first until after the study is over.

 

A medical doctor will be present during all visits, and if you do not feel well, we will stop the testing for that day.  You may also stop and drop out of the study, at any time, if you want.

 

·        Are there good things and bad things about the study?

The test results from the study can help the doctors, so that they know what asthma medications to give you to help you breathe.  Your nose or throat might feel salty or get sore during the nasal and sputum tests.  The breathing tests and ozone could make you cough, feel short of breath, make your chest feel tight or give you a headache.  If your asthma feels worse, you can use your breathing medication.  The doctor will be here.  The blood tests can hurt like a mosquito bite, make your arm red, and sometimes you might get a bruise.  The skin test can hurt like a mosquito bite, and may cause a small raised reddened area that may itch, but it will start to disappear after 10-20 minutes.

 

 

·        Who will know about what I did in the study?

You, your parents, the doctor and the staff at the Gage will know about what you did.  If the doctors want to talk about this study sometimes, then they might talk about your test results, but they won't talk about you specifically, or even mention your name.

 

 

·        Can I decide if I want to be in the study?

Yes.

 

 

·        Assent:

"I was present when __________________________read this form and gave his/her verbal assent."

 

__________________________________________Name of person who obtained assent

 

__________________________________________Signature

 

__________________________________________Date