Emory University IRB
IRB use only
Study No.: IRB00047709
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
Emory University and Children’s Healthcare
Consent to be a Research Subject
Version 3.1, June 26, 2012
Title: APRIL - Azithromycin for Preventing the development of upper Respiratory tract Illness into
Lower respiratory tract symptoms in children
and
OCELOT - Oral Corticosteroids for treating Episodes of significant LOwer respiratory Tract
symptoms in children
Principal Investigator: Anne M. Fitzpatrick, PhD, Karen DeMuth, MD
Sponsor: National Institutes of Health (NIH), National Heart, Lung and Blood Institute’s AsthmaNet
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 since your child is between 12 and 71 months of age (1
year to almost 6 years old) and is healthy other than having repeated wheezing episodes. 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. Please take your time making a decision. Feel free to discuss it with your friends,
family, and doctors. Before agreeing for your child to take part in this research study, it is important that you
read this consent form because it explains the study and any of the risks that it may involve. No guarantees or
promises can be made regarding your child’s experience in the study. Please ask the study doctor or the study
staff to explain any words, ideas, or information that are not clear to you. If you choose not to take part, this will
in no way affect your usual health care.
Being in a research study does not take the place of routine physical exams or visits to your own doctor.
Research study visits should not be used to diagnose or treat medical
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 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.
Why is this study being done?
Preschool aged children often have severe bouts of coughing and/or wheezing that lead to visits to the doctor’s
office, urgent care, emergency room and often hospitalization. The purpose of these studies is to look at two
treatment plans. One treatment plan will try to prevent bad coughing or wheezing illness from happening. This
is called the Azithromycin for Preventing the development of upper Respiratory tract Illness into Lower
respiratory tract symptoms in children, or APRIL Study. The second treatment plan will try to decrease the
Page 1 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
symptoms if an illness does develop during APRIL treatment. This is called the Oral Corticosteroids for treating
Episodes of significant LOwer respiratory Tract symptoms in children, or OCELOT study. By agreeing to take
part in this study, you are agreeing to take part in both the APRIL and OCELOT studies.
Participants will not get daily asthma therapy in this study. The treatments in these studies are only given
during respiratory (breathing) illnesses. All participants will get inhaled albuterol to use as needed.
The APRIL study will see if starting the oral antibiotic azithromycin at the early signs of a respiratory illness is
better than a placebo (fake or inactive) medication in preventing the development of significant breathing
symptoms such as severe frequent coughing, trouble breathing, shortness of breath, or wheezing.
Azithromycin is approved by the U.S. Food and Drug Administration (FDA). It is approved for use in children. It
is used for the treatment of respiratory tract infections caused by bacteria (ear infections, pneumonia and sinus
infections). Its use in this study is considered investigational because this study uses azithromycin at the early
signs of a respiratory illness rather than after bacterial illnesses are clearly present. The FDA is aware of this
and has given us permission to use this product in this trial.
If your child develops significant coughing, trouble breathing, shortness of breath, or wheezing during the
APRIL study, you will immediately call a study physician. The study physician will decide if the APRIL
treatment was not effective, and if your child should begin the OCELOT treatment. OCELOT is studying if
giving oral corticosteroids (prednisolone) is more effective than a placebo in reducing breathing symptoms over
the next 72 hours. Prednisolone is FDA approved for the treatment of acute asthma episodes in children.
This study is funded by the National Institutes of Health’s National Heart, Lung and Blood Institute. Emory
University is one of 16 clinical centers in the country doing this study. A total of 600 children will take part in
this study, about 67 of who will take part at Emory University. Your child’s involvement will last about 18
months (82 weeks).
What am I being asked to do?
ASTHMANET REGISTRATION: Before your child is enrolled in an AsthmaNet study, he/she must first be
entered into the AsthmaNet Registry. This Registry has been set up to collect basic background information
that will probably not change over time. This information is limited to: initials, date of birth, gender, and
race/ethnic identification. Your child’s Registry information will be coded with a unique AsthmaNet identification
number. No information that directly identifies your child will be entered into the AsthmaNet database or sent to
the Data Coordinating Center (Penn State University, Hershey, PA). Registry data help us track your child’s
participation in multiple AsthmaNet studies over time. Knowing that your child was in more than one study is
useful in certain types of data analyses.
Your agreement to provide the information for the AsthmaNet Registry is voluntary. However, if you choose not
to provide it, your child cannot be screened for or enrolled in any AsthmaNet study. Once you consent to have
your child entered into the Registry, his/her 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 child’s
participation in AsthmaNet studies. Registration happens before or during your child’s first study visit (visit 1).
EVALUATION PERIOD: The first 14-28 days of the study will be an evaluation period to find out if your child
qualifies for the study and if you can follow the study instructions. Children not taking a daily asthma controller
medication will have a 14-day evaluation period. Children who have well-controlled asthma and are taking a
daily controller medication (either a low dose of an inhaled corticosteroid or Singulair) will be asked to stop
their daily medication and will have a 28-day evaluation period. This longer evaluation period will be used to
make sure it is safe for your child to be off daily treatment.
Page 2 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
During the evaluation period, you will be asked to complete a daily diary of your child’s breathing symptoms
and albuterol use. To qualify to continue in the study, your child’s symptoms may not be too frequent or too
severe.
TREATMENT DURING BREATHING ILLNESSES: Eligible children will enter the treatment phase of the
study and will be assigned to a study medication group for both APRIL and OCELOT treatment. Study
medication groups are assigned randomly, like the flip of a coin. You have an equal chance of being in any of
the four groups below.
There are four treatment groups in this study:
Group 1
Group 2
Group 3
Group 4
APRIL – Treatment to be
started at the early signs of a
respiratory illness
Azithromycin
Azithromycin
Placebo
Placebo
OCELOT – Treatment to be started if
the APRIL treatment does not
prevent significant symptoms
Prednisolone
Placebo
Prednisolone
Placebo
Your child’s treatment group will be kept a secret. Neither you, your child, nor the study personnel will know
which group your child was assigned to. However, this information can be made available if necessary.
The study medications will be used only if a respiratory illness develops. Children will not receive daily
controller medication for asthma. However, albuterol (provided by the study) may be used as needed for
breathing symptoms.
APRIL TREATMENT: You will be responsible for watching your child for signs of a respiratory illness. At the
first sign of a respiratory illness, your child should begin the APRIL medication. The APRIL medication will be
either the antibiotic azithromycin or placebo and your child will take it once a day for 5 days. The same APRIL
medication will be given during each respiratory illness during the study. Your child will not have more than 4
respiratory illnesses treated with APRIL medication over the 18 month study. Once your child has had 4
respiratory illnesses, his/her participation in the trial is done. You will be asked to pay close attention to your
child’s respiratory illness during APRIL treatment. You and your child will receive extensive education on
breathing illnesses throughout the study. You will be given verbal and written directions telling you what to do if
the breathing illness worsens.
OCELOT TREATMENT: If your child develops a respiratory illness that worsens during APRIL treatment, your
action plan will help you determine if you need to call study personnel immediately. You will be able to contact
study personnel (either a coordinator or the after-hours nurse triage center) 24 hours a day, 7 days a week.
The study personnel will decide if OCELOT treatment should begin. OCELOT treatment will be either
prednisolone or placebo based on the group to which your child has been randomly assigned. If OCELOT
treatment should be started, you will be instructed to begin OCELOT treatment. Your child will take this
medication twice daily along with inhaled albuterol. You will be contacted by phone approximately 1 hour and
24 hours later to discuss your child’s condition. Your child must be seen in the clinic 36-72 hours after
starting OCELOT treatment for a physical examination. At that time, the OCELOT study medication may be
stopped if the study physician feels that is in the best interest of your child. Your child will return for a final clinic
visit two weeks later to evaluate his/her symptoms. Following this visit, your child’s participation in the study is
complete.
CONTACTING THE STUDY TEAM: If you have any questions about your child’s study participation during
weekdays, please contact the research coordinators at Emory University: Denise Whitlock at telephone
Page 3 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
number 404-712-1773 or Jennifer Dodds at telephone number 404-727-5176. If you have any questions about
your child’s asthma or health during nights [after 5:00PM], weekends or holidays, or if your action plan directs
you to call the study team after hours, please call FONEMED 855-855-5783.
FONEMED is a call center staffed with nurses (RNs) who are very well trained to make medical decisions.
FONEMED is a national call center that provides medical coverage for pediatricians across the United States.
FONEMED makes medical decisions for children using standardized questionnaires that are approved by the
American Academy of Pediatrics. For this study, FONEMED will also provide medical coverage for the Emory
University at night and during holidays and weekends. If you call FONEMED, the trained nurses will ask you a
series of questions about your child’s health and then advise you on the appropriate care for your child’s
situation. If your child is sick and needs medical care of any kind, FONEMED will contact the study physician
right away to discuss your child’s situation. Depending on what the study physician says, you may be asked to
start study medication (either APRIL or OCELOT), or else you may be asked to take your child to the
Emergency Room immediately. You will then receive a phone call from the study team (the study physician
and/or the study coordinator, and possibly FONEMED as well) approximately 1 hour later to check on how your
child is doing. The purpose of the FONEMED call center is to ensure that your child will receive appropriate
medical advice at all times, including nights and weekends when the study doctors may be more difficult to
reach by phone. We recognize that many people are uncomfortable calling physicians at night and on
weekends. However, by using FONEMED, we hope that this will encourage you to call with medical questions
at any time, even if you think they are minor. The study physician and the study coordinators will not be upset
if you call FONEMED.
Your child may receive OCELOT treatment only once during the study. After your child has received one
course of the OCELOT treatment, his/her participation in the trial is done. Keep in mind that not all children in
the study will need OCELOT treatment.
Overall, your child will return for study visits 1 month after the randomization visit, and then every 2 months
until the end of the study. You will also be called for scheduled telephone interviews 1 month after each clinic
visit to find out about your child’s symptoms and medication use, and to see if any other problems have
occurred.
RESPIRATORY ILLNESS ACTION PLAN: You and your child will be given an action plan to help manage
your child’s breathing symptoms. You will be able to get advice about how to treat symptoms 24 hours a day,
7 days a week by contacting the study doctors and coordinators or after-hours triage nurse center. You will be
asked to start APRIL medications when you notice that your child has early signs of a respiratory illness. Signs
of a respiratory illness will be determined by you, the parent. You do not need to call the [clinical site] in order
to start albuterol or the APRIL medications. However, you will be asked to call FONEMED 855-855-5783
or after-hours triage nurse within 24 hours of starting APRIL study medication to discuss your child’s
symptoms. FONEMED is a call center designated for this study only. You will also be asked to call immediately
if your child’s symptoms are getting worse or if you need additional advice.
PLEASE NOTE: YOU SHOULD SEEK IMMEDIATE MEDICAL ATTENTION IF YOUR CHILD HAS SEVERE
BREATHING DIFFICULTY. THIS MAY MEAN CALLING 911 IMMEDIATELY!
UNEXPECTED ER/ URGENT CARE / HOSPITALIZATION: If your child is seen in the Emergency Room (ER)
or urgent care for breathing symptoms, he/she may be treated by his/her physician according to standard
asthma treatment guidelines. You should let the physician treating your child know that your child is
participating in this study. You should also contact Dr. Anne Fitzpatrick at telephone number 404-727-9112 or
Dr. Karen Demuth at telephone number 404-778-2400 or after-hours triage nurse as soon as possible to
discuss whether your child should continue to receive study medications or not. If your child receives oral
corticosteroids (like prednisone or prednisolone) during the ER or urgent care visit, your child will stop all study
medications. Your child will return to the clinic for a final study visit within two weeks and then your child will
Page 4 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
return to his/her usual physician for ongoing care. Following the visit, your child’s participation in the study is
complete.
If your child is hospitalized for asthma, your child may be treated by his/her physician according to standard
asthma treatment guidelines. You should let the physician treating your child know that your child is
participating in this study. You should also contact Dr. Anne Fitzpatrick at telephone number 404-727-9112 or
Dr. Karen Demuth at telephone number 404-778-2400 or after-hours triage nurse as soon as possible. Your
child will stop the study medications. Your child will return for a final study visit within two weeks and then your
child will return to his/her usual physician for ongoing care. Following the visit, your child’s participation in the
study is complete.
PROCEDURES
Participation in this study will require up to 12 study visits and 9 study telephone calls over about 18 months.
The first visit will last 2½ to 3 hours, the second visit will last 1-2 hours, and the other visits will be about 1 hour
each. The telephone calls will last less than 15 minutes each. Please see the table following the procedure
descriptions for a list of procedures by visit.
A description of the procedures follows:
Physical examination includes weight and height measurements, and examining your child’s lungs, skin,
nose, and mouth.
Asthma questionnaires will help tell us how you feel about your child’s health, coughing or wheezing
episodes and how this affects your child’s life. These will be done at some of the visits throughout the study.
Environmental survey consists of questions about the things that your child is exposed to in the home like
pets, house dust mites, and smokers.
A blood sample will be taken once at visit 2. The tests include a cell count and tests for features of allergy.
About 1-2 teaspoons of blood will be taken. With your permission, a small amount of your child’s blood
sample, including DNA, will be saved for future analyses of features of asthma or respiratory disease that may
be relevant to the results of this study. You will be given another form to indicate whether you give permission
for your child’s blood and DNA to be saved for future use. The sample will not be saved without your
permission.
Nasal mucus sampling. Nasal mucus will be obtained from your child to find out which respiratory germs are
present. It will be collected either by nose-blowing into a plastic bag or with a nasal swab for those children
unable to blow their nose. Your child’s nasal mucus will be collected by the coordinators during your child’s 2nd
and final study visits. These samples will tell us which germs are ‘usually’ present. You will collect samples at
home during respiratory tract illnesses prior to starting the study medication(s). These samples will tell us
which germs are present during the respiratory infection. We will teach you how to collect the mucus and
provide you with supplies and storage instructions.
Diary completion. Your child’s symptoms and medication use will need to be recorded on a diary card each
day during the evaluation period and during each respiratory illness.
Page 5 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Emory University IRB
IRB use only
Study No.: IRB00047709
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
The specific tests and procedures performed at each visit are listed in the table below:
Week
-2 to -4
0
4
12
20
28
36
44
52
60 68 76
OCELOT FINAL
VISIT
VISIT
APRIL FOLLOW-UP VISITS
Visit Number
1
2*
Telephone Calls
3
4
5
6
7
8
9
10 11 12
Every 4 weeks between visits 3 and 12
Informed Consent
+
Medical History
+
Complete Physical
Exam
+
+
Brief Physical Exam
+
+
+
+
+
+
+
+
+
+
+
Review Diary Cards
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
Questionnaires
+
Blood Test
+
Nasal Mucus Sample
+
Survey of Symptoms
+
Review Medication
Use
Review Action Plan
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
+
* Randomization visit
Although the table shows that there are 12 visits in the APRIL study, your child’s participation in APRIL will end
prior to visit 12 if any of the following occur:
 your child needs to start APRIL treatment for a fourth time
 your child needs to start OCELOT treatment
 your child develops persistent asthma-like symptoms requiring daily therapy
If any of these things happen before visit 12, then your child will skip the rest of the APRIL visits and go straight
to the final visit. If none of them happen, then visit 12 will be the final study visit.
PARTICIPATION RESPONSIBILITIES
You should try hard to keep appointments and phone calls. Call the study coordinator if you must change your
appointment. Please truthfully complete questionnaires and diaries. The study medications you are given
during this study should be stored at room temperature under dry conditions away from direct sunlight. The
study medications MUST be taken only by the person for whom it has been prescribed. The study medications
should only be taken as directed by your study doctor. The study medications should be kept out of the reach
of other children or people who cannot read or understand the labels on the medications. Do not stop the study
medications unless you are instructed to do so by study staff. If albuterol does not lessen your child’s asthma
symptoms, you should contact Dr. Anne Fitzpatrick at telephone number 404-727-9112 or Dr. Karen Demuth at
telephone number 404-778-2400 immediately. Uncontrolled wheezing episodes can be life threatening. If
asthma symptoms worsen you should call the study coordinator, Denise Whitlock at 404-712-1773 or Jennifer
Dodds at 404-727-5176 during regular office hours or after-hours nurse triage at FONEMED 855-855-5783.
If serious asthma symptoms develop contact the closest emergency room (ER) immediately.
Page 6 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
STUDY DIARIES AND ALL STUDY MEDICATIONS (USED AND UNUSED) SHOULD BE BROUGHT TO
EVERY STUDY VISIT.
What are the risks?
Being part of this study may involve some risks or discomforts. No procedures are part of standard treatment.
Throughout the study the study team will watch your child very closely for any possible complication. The
study coordinators and staff at the research center are experienced in the care of children. Medications and
equipment are available to take care of possible problems that may occur during study visits. There is the risk
of loss of confidentiality when you join a study. Study staff is trained in protecting privacy. Steps will be taken
to ensure your confidentiality (see HIPAA form).
Any medication or procedure may cause side effects. The most common side effects for study medications
and procedures are listed below. These include, but are not limited to the following:
Respiratory symptom worsening:
Likely: Your child’s respiratory treatment might have changed when you joined this study. It is possible that
changing your child’s asthma medications might worsen your child’s asthma. Your child may experience
increased asthma symptoms during the study that would need to be evaluated and possibly treated with
additional non-study medications.
Respiratory and other questionnaires:
Less Likely: Your will be asked to complete questionnaires at every visit. Questions will be about allergy and
respiratory/asthma history, and medical facts about your child and family and your environment. You will also
be asked questions about how your child’s quality of life is affected by asthma. These questionnaires are like
those used in the allergy and asthma doctor’s office. You or your child may feel uncomfortable when answering
some questions. You may refuse to answer such questions. The interviews/questionnaires will take about onehalf hour at each visit. These questionnaires may be inconvenient because of the time they take to complete.
Your responses to the research questions will be coded to protect your confidentiality.
Blood Sampling:
Likely: The risks with taking blood include possible pain from the skin puncture, as well as bleeding or
bruising of the skin.
Rare: There is a rare risk for infection at the place of puncture of the skin. Lightheadedness, dizziness, and
fainting may occur.
A local anesthetic cream (a medicine to numb the skin), may be placed on the skin before the needle is
inserted. This may reduce the pain your child might feel. The use of this cream is optional. If you would like to
use this cream, it must be on your child’s skin 30-60 minutes before the blood is taken.
Less Likely: Some local effects of the cream (at the site where it is placed) include paleness, redness,
changes in feeling temperature sensations like heat and cold, mild swelling, itching, and rarely, rash.
Nasal Mucus Sampling:
If your child is old enough for the nasal blow sample, there are no risks involved. There may be risks with
using a nasal swab to collect the sample.
Rare: Mild irritation at the opening of the nose where the nasal swab is placed during the nasal mucus
collection may be felt. If your child were to suddenly move his/her head during the nasal sampling procedure, it
is possible that the nasal lining will get scraped and bleed. Any of these risks are very unlikely since the tip of
the nasal swab is very soft and will only be put into the nose a short distance.
Page 7 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
Medical History, Physical Exams and Partial Physical exams: There are no risks associated with these
procedures.
Study Medication Risks:
Albuterol: Albuterol is the “rescue” inhaler your child will be given to use as needed for control of acute
breathing symptoms.
Likely: Albuterol may cause the heart rate to increase and your child to feel shaky, sick to the stomach,
nervous, lightheaded, or dizzy. It is likely that your child already uses albuterol and you are familiar with how
he/she responds to this medication.
Azithromycin: Azithromycin is an antibiotic taken by mouth.
Less Likely: Side effects are mostly related to the digestive system. Children may have diarrhea or loose
stools, nausea or feeling sick to the stomach, abdominal or stomach pain. These side effects may be
prevented by taking this medication with food or milk.
Rare: Serious allergic reactions, including hives or other rashes, swelling and a drop in blood pressure have
been reported. If signs of an allergic reaction occur, stop the medication and contact the clinical center. In
some people, the rash can continue for some time after the medication is stopped. People should not join this
study if they are allergy to antibiotics like azithromycin [erythromycin (Ilosone®) or clarithromycin (Biaxin®)].
Please make sure that the study team knows about your child’s drug allergies.
Rarely, severe stomach cramps or pain can occur. Azithromycin may rarely cause bloody diarrhea. Should
severe symptoms such as cramps or pain, or bloody diarrhea occur, stop the medication and contact the
clinical center. Serious allergic reactions and severe diarrhea have caused death in rare situations. Other rare
side effects include heart fluttering or chest pain, increased stomach gas, vomiting, or jaundice (yellowing of
the eyes or skin), yeast infections of the mouth or vagina, dizziness, headache, tiredness, sleeplessness,
ringing in the ears or sleepiness. These have occurred mostly in adults taking azithromycin. Azithromycin is
usually well tolerated by children.
Prednisolone: This is an oral corticosteroid that reduces inflammation and swelling in the airways.
Less Likely: Short courses of oral corticosteroids can cause wakefulness, fussiness and an increased
appetite.
Rare: Prednisolone can cause hoarseness, sore throat, and yeast infection of the mouth or throat if taken in
high doses for long periods of time (months to years). Long-term use can also cause weight gain, growth
delay, bruising of the skin, cataracts, and diabetes. These effects are more likely if the medicine is taken at
very high doses for long periods of time. These long-term side effects are not expected to occur in this study
because, if prednisolone is given, it will be given once for only 5 days.
Other Study Risks: There is always the risk of having a previously unknown side effect. You will be told of any
major new findings. The investigator or study staff is willing to discuss any questions you might have about
these possible risks and discomforts.
New Information
It is possible that the researchers will learn something new during the study about the risks of being in it. If this
happens, they will tell you about it. Then you can decide if you want to continue to be in this study or not. You
may be asked to sign a new consent form that includes the new information if you decide to stay in the study.
Are there benefits to taking part in the study?
Your child may benefit by receiving a physical examination and frequent asthma assessments. You and your
child will receive asthma education and treatment of respiratory symptoms symptoms while in the study. Being
Page 8 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
in the study may help the study doctors learn more about asthma. The study might find the best treatment of
frequent wheezing in young children. This may benefit children with respiratory symptoms and asthma in the
future. If the study learns something that would have a serious impact on your child’s health, you will be
informed.
COMPENSATION
Participants will be compensated for travel, time effort and other expenses related to each visit, phone call or
procedure. Payment will be based on the number of completed visits. Non-monetary incentives such as small
toys may be given to children for participating. The following schedule of payment is planned:
$80 for completion of the first visit
$100 for completion of the second visit
$50 for completion of visits 3, 4, 5, 6, 7 , 8, 9, 10, and 11
$80 for completion of visit 12
$100 for completion of the OCELOT visit
$80 for completion of the Final visit
$20 for completion of each phone call
At most, $1,070 in compensation may be provided to each participant. If you withdraw your child from the study
prior to completion, payment will be prorated for study visits completed.
Please note that Emory University is required to complete form 1099 for any participant payments exceeding
$600. To comply with the federal mandate, the researchers are required to obtain your social security number
to complete the form. You will be responsible for reporting this compensation when you file your tax return.
What other options are there?
Taking part in this research study is voluntary. You may choose not to take part in this research study or you
may withdraw your consent at any time. You may withdraw by telling the study team you are no longer
interested in participating in the study or you may send in a withdrawal letter. Your choice will not affect the
commitment of your health care providers to administer care. There will be no penalty or loss of benefits to
which you are otherwise entitled.
There are many treatments available for asthma and/or wheezing. Your child does not have to take part in this
study to receive treatment for his/her symptoms. If you decide not to give permission for your child to take part
in this study, or if your child withdraws from the study, your child’s usual personal doctor should manage the
disease using available medications or treatments. However, if you decide to let your child take part in this
study, you must agree to use only the medications allowed while your child is in the study.
The study doctor might be your child’s personal doctor. This doctor is interested both in your child’s welfare
and in the conduct of this study. Before entering this study, or at any time during the study, you may ask for a
second opinion about your child’s care from another doctor who is not associated in any way with this study.
The study doctor may decide to stop your child’s participation without your permission. This could happen if the
study doctor thinks that being in the study may cause your child harm.
What about privacy and confidentiality?
Certain offices and people other than the researchers may look at your medical charts and study records.
Government agencies and Emory employees overseeing proper study conduct may look at your study records.
These offices include the Food and Drug Administration, the National Institutes of Health, the Emory
Institutional Review Board, the Emory Office of Research Compliance and the Office for Clinical Research.
Page 9 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
Study sponsors may also look at your study records. Emory will keep any research records we create private
to the extent we are required to do so by law. A study number rather than your name will be used on study
records wherever possible. Your name and other facts that might point to you will not appear when we present
this study or publish its results.
There is a Certificate of Confidentiality for this Study
This will help further protect information that may identify your child. The Certificate prevents the investigator
from being forced to disclose identifying information for use in court. The investigator may not even be forced
by court subpoena. Courts that may be prevented from getting your child’s information include any federal,
state, local civil, criminal, administrative, legislative, or other court proceeding.
What the Certificate of Confidentiality protects:
The National Institutes of Health has given this study a Certificate of Confidentiality. Emory would use it to
block a legal request to give out study information. For example, if Emory received a subpoena for study
records, we would say no. The Certificate gives Emory legal backup to say no. It covers information about
you that could harm your image or finances. It also covers information about you that could harm your
chances at a job or getting insurance.
What the Certificate of Confidentiality does not protect:
The Certificate would not protect some information about you, including any information:
 you give out yourself
 someone other than you or Emory gives out
 that Emory must give to state public health offices about certain infectious diseases
 that Emory must give to law officials if child abuse has taken place
 that Emory must give to prevent immediate harm to you or others
 that Emory needs to give to the study sponsor
What the Certificate of Confidentiality does not protect
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family
from voluntarily releasing information about yourself or your child’s involvement in this research. The
investigator may not withhold information if you give your insurer or employer permission to receive information
about your child’s participation in this research. This means that you and your family must also actively protect
your own privacy.
The Certificate cannot be used to resist a demand for information from personnel of the United States
Government that is used for auditing or evaluation of federally funded projects or for information that must be
disclosed in order to meet the requirements of the FDA.
Research Information Will Go Into the Medical Record:
If you are or have been an Emory Healthcare patient, you have an Emory Healthcare medical record. If you
are not and have never been an Emory Healthcare patient, you do not have one. Please note that an Emory
Healthcare medical record will be created if you have any services or procedures done by an Emory provider
or facility for this study.
If you agree to be in this study, a copy of the consent form and HIPAA patient form that you sign will be placed
in your Emory Healthcare medical record. Emory Healthcare may create study information about you that can
help Emory Healthcare take care of you. For example, the results of study tests of procedures. These useful
study results will be placed in your Emory Healthcare medical record. Anyone who has access to your medical
Page 10 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
record will be able to have access to all the study information placed there. The confidentiality of the study
information in your medical record will be protected by laws like the HIPAA Privacy Rule. On the other hand,
some state and federal laws and rules may not protect the research information from disclosure.
Emory does not control results from tests and procedures done at other places. So these results would not be
placed in your Emory Healthcare medical record. They will not likely be available to Emory Healthcare to help
take care of you. Emory also does not have control over any other medical records that you may have with
other healthcare providers. Emory will not send any test or procedure results from the study to these providers.
So if you decide to be in this study, it is up to you to let them know.
The researchers will review the results of certain study tests and procedures only for the research. The
researchers will not be looking at the results of these tests and procedures to make decisions about your
personal health or treatment. For this study, this includes blood tests.
In Case of Injury
If you get ill or injured from being in the study, Emory would help you to get medical treatment. Emory and the
sponsor have not, however, set aside any money to pay you or to pay for this medical treatment. The only
exception is if it is proved that your injury or illness is directly caused by the negligence of an Emory or sponsor
employee. “Negligence” is the failure to follow a standard duty of care.
If you become ill or injured from being in this trial, your insurer will be billed for your treatment costs. If you do
not have insurance, or if your insurer does not pay, then you will have to pay these costs.
If you believe you have become ill or injured from this research, you should contact Dr. Anne Fitzpatrick at
telephone number (404) 727-9112 or Dr. Karen DeMuth at (404) 778-2400. You should also let any health
care provider who treats you know that you are in a research study.
What are the costs?
There will be no costs to you for participating in this study. You will not be charged for any of the research
activities. All study tests, study medications, and study visits and phone calls are provided without cost to you
or your healthcare provider or insurance company. The sponsor of the study is the National Institutes of
Health/National Heart, Lung and Blood Institute (NIH/NHLBI), and they will cover study costs. Medical care
needed to treat your child’s asthma outside of study visits (including physician visits, ER or urgent care visits or
hospitalizations) during the course of the study will need to be paid for by you or your health care insurer. This
may include copayments and/or other supplemental charges required by your plan.
Withdrawal from the Study
You have the right to leave a study at any time without penalty. If you leave the study before the final planned
study visit, the researchers may ask you to have some of the final steps done.
The researchers and sponsor also have the right to stop your participation in this study without your consent if:
 They believe it is in your best interest;
 You were to object to any future changes that may be made in the study plan;
 or for any other reason.
Whom do I call if I have questions or problems?
Page 11 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
Please contact the researcher listed below to:





Obtain more information about the study
Ask a question about the study procedures or treatments
Report an illness, injury, or other problem (you may also need to tell your regular doctors)
Leave the study before it is finished
Express a concern about the study
Contact Dr. Anne Fitzpatrick at 404-727-9112:
 if you have any questions about this study or your part in it,
 if you feel you have had a research-related injury or a bad reaction to the study drug, or
 if you have questions, concerns or complaints about the research
Contact the Emory Institutional Review Board at 404-712-0720 or 877-503-9797 or irb@emory.edu:
 if you have questions about your rights as a research participant.
 if you have questions, concerns or complaints about the research.
 You may also let the IRB know about your experience as a research participant through our Research
Participant Survey at http://www.surveymonkey.com/s/6ZDMW75.
CONSENT AND AUTHORIZATION TO PARTICIPATE IN THE APRIL/OCELOT RESEARCH STUDY:
Please, print your name and sign below if you agree to be in this study. By signing this consent form, you will not
give up any of your legal rights. We will give you a copy of the signed consent, to keep.
I have read this consent form and have been given the chance to ask questions. I give permission for my child
to take part in this research explained above, titled: APRIL - Azithromycin for Preventing the development of
upper Respiratory tract Illness into Lower respiratory tract symptoms in children and OCELOT - Oral
Corticosteroids for treating Episodes of significant LOwer respiratory Tract symptoms in children.
HRPO does not require participants to re-sign the consent form unless a change is made; the investigator,
however, may choose to re-consent participants at any time.
Name of Subject
Signature of Person Conducting Informed Consent Discussion
Date
Time
Signature of Legally Authorized Representative
Date
Time
Authority of Legally Authorized Representative or Relationship to Subject
Page 12 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012
Study No.: IRB00047709
Emory University IRB
IRB use only
Document Approved On: 7/24/2012
Project Approval Expires On: 2/9/2013
I have given this research participant (or his/her legally authorized representative) information about this study
that I believe is accurate and complete. The participant has indicated that he or she understands the nature of
the study and the risks and benefits of participating.
Signature of Principal Investigator or Co-Investigator
Date
Time
Request Permission for Future Contact
1. May we contact you for future undetermined studies conducted
by Emory University or the AsthmaNet?
If yes, we will need to look at your child’s Protected Health
Information (PHI) to check for study eligibility.
2. May we contact you for future studies about asthma?
If yes, we will need to look at your child’s PHI.
3. May other Emory University physicians conducting research on
(disease/diagnosis) contact you? If yes, your child’s PHI may be
shared with other physicians.
___ Yes
___ No
___ Yes
___ No
___ Yes
___ No
Taking part in future studies is optional. You can ask us at any time to take your child off our contact list.
Page 13 of 13
IRB Form 04232012
Version Date: Version 3.1, June 26, 2012