Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
Emory University and Children’s Healthcare
Consent to be a Research Subject
Version Date: July 20, 2012
Title: INFANT – INDIVIDUALIZED THERAPY FOR ASTHMA IN TODDLERS
Principal Investigator: Anne M. Fitzpatrick.
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 59 months of age
(1 year to almost 5 years old) and is healthy other than having asthma. Joining this study is voluntary. Please
take your time making a decision. Feel free to discuss it with your friends, family, and doctors. This consent
form explains the study and any risks that may be involved. Please ask the study doctor or the study staff to
explain any words, ideas, or information that are not clear to you. If you decide not to enroll your child, any
relationship you have with Emory University and its doctors will not be changed in any way.
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. It is entirely your choice. If you decide to take part, you can change
your mind later on and withdraw from the research study. The decision to join or not join the research
study will not cause you to lose any medical benefits. If you decide not to take part in this study, your doctor
will continue to treat you.
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 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.
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. law. This
Web site will not include information that can identify you. At most the Web site will include a summary of the
results. You may search this Web site at any time.
Why is this study being done?
The purpose of this study is to find out if one asthma treatment works better than another in toddlers. Another
purpose is to see if there is something about a child that helps doctors predict which treatment would work
better. For example, maybe one treatment works best in boys who also have allergies.
The asthma guidelines state that inhaled corticosteroids taken every day is a good choice for children under 5
years. However, this is based on information from older children. Maybe toddlers only need to take an inhaled
corticosteroid like fluticasone when they have asthma symptoms. Or maybe an oral medication like
montelukast is better.
Page 1 of 9
IRB Form 02242012
Version Date: 07/20/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
It is possible that medications used to treat fever or body aches (such as Tylenol or Motrin) work differently in
children with asthma. There is a study looking at this question and it is called the AVICA study. If you join the
INFANT study, you must also join the AVICA study. See separate consent form for AVICA details.
This study is funded by the National Institutes of Health’s National Heart, Lung and Blood Institute (NIH
NHLBI). [insert site] is one of 9 clinical centers in the country doing this study. A total of approximately 900
children may need to be enrolled in this study in order for approximately 300 children from across the nation to
be randomized in this study. About 33 children will be randomized at Emory University.
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).
RUN-IN PERIOD: The first 2-8 weeks of the study is called the run-in. It will be used to find out if your child
qualifies for the study and if you can follow the study instructions.
All children will take a study inhaler and study oral medication during the run-in. The study inhaler might be
fluticasone or placebo. The study oral medication might be montelukast or placebo. A placebo is a look-alike
(fake or inactive) medication. You will know if your child is on active or placebo drug during the run-in. The
purpose of giving your child a placebo study inhaler and/or placebo study oral medication is to make sure they
can take these medications on a daily basis.
The length of the run-in and run-in treatment depends on your child’s asthma controller treatment before they
started the study and their symptoms during the run-in period.
You will be asked to complete an electronic diary, noting your child’s asthma symptoms and medication use. At
the end of the run-in, the study coordinator will look at your child’s symptoms to make sure it is safe for them to
be in this study. In addition, the study coordinator will look to see that you completed a majority of the diary
entries.
If your child continues to qualify for the study, they will then begin the treatment period.
TREATMENT PERIOD: During the treatment period your child will be asked to take a study inhaler and study
oral medication every day, just like during the run-in. Your child will also be asked to take puffs from another
study inhaler whenever they take albuterol, matching the number of puffs. For example, if your child took 2
puffs of albuterol, they would immediately take 2 puffs from this second study inhaler.
During the treatment period, either the daily study inhaler, daily study oral medication or “with albuterol” study
inhaler will be active. Your child will go through each of these treatment options. For 16 weeks in a row, the
daily study inhaler will be active. For another 16 weeks the daily oral medication will be active. Lastly, your
Page 2 of 9
IRB Form 02242012
Version Date: 07/20/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
child will have 16 weeks during which the “with albuterol” inhaler is active. The order of which treatment is
active first, second and third is decided randomly, like the flip of a coin.
Your child’s treatment will be kept a secret. You and the study team will not know which study medication is
active and which is placebo. However, this information can be found out, if necessary.
All children will receive albuterol to use as needed during the study. You will also get a supply of prednisolone
to use if your child has a worsening of their asthma. You and your child will be given an action plan to help
manage your child’s breathing symptoms.
MEDICATIONS
Study inhalers: Fluticasone propionate (Flovent® 44 mcg/puff) is an inhaled corticosteroid. It is commonly
prescribed for the treatment of asthma. The dose in this study is thought to be the lowest effective dose to
control symptoms.
Flovent® is only approved for daily scheduled use in children 4 years and older and its use in children less
than 4 years of age is considered investigational. However, Flovent® has been previously studied in preschool
children. Those studies have shown that it is safe and well tolerated in this age group when given on a daily
basis. For ease of use, the inhaler will be attached to a holding chamber with a face mask. Your child will be
asked to take 2 puffs of the Flovent® or matching placebo twice a day, every day.
A Flovent® or matching placebo inhaler will also be taken with each puff of albuterol. The daily Flovent® and
the “with albuterol” Flovent® will not be active at the same time. The use of Flovent® on an “as-needed” basis
is considered “experimental.” Flovent® has not been approved for “as needed” use in any age group,
including preschool children.
Study oral medication: Montelukast (Singulair® 4 mg chewable tablet or granules) is a leukotriene receptor
antagonist. It is FDA approved for use in children 12 months and older. Your child will be asked to take
montelukast or matching placebo once a day at bedtime.
Rescue medications: Albuterol sulfate (90 mcg per puff) is a short acting bronchodilator. Your child may take
puffs whenever they typically use albuterol. They must also take a matching number of puffs of the second
study inhaler with each puff of albuterol. As described above, the second study inhaler is either fluticasone or
placebo. The study coordinator will tell you if there is a cap or limit on the number of doses of albuterol your
child may take each day.
Prednisolone is an oral steroid used to treat worsening of asthma. The dose will be calculated based on your
child’s weight. If needed, your child will take one dose for 2 days and then a lower dose for 2 more days. You
will get a written action plan describing this.
PROCEDURES
This study has 8 scheduled study visits and 6 scheduled study telephone calls. The run-in is 2-8 weeks long
and the treatment period is 48 weeks long (about 11 months). Most visits will take less than one hour. The first
2 visits may last longer. The telephone calls will take 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.
Medical history is an interview that tells us about the overall health of your child.
Page 3 of 9
IRB Form 02242012
Version Date: 07/20/2012
Emory University IRB
IRB use only
Study No.: IRB00057906
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
Questionnaires will tell us about your child’s health, how this affects you and your child’s life, and about the
things that your child is exposed to in the home like pets, house dust mites, and smokers. You will also be
asked to complete a satisfaction questionnaire at your child’s final visit.
A blood sample will be taken at visit 2. The blood may be drawn in as many as 5 small tubes but less than
one tablespoon (15 ml) of blood will be taken all together. The blood tests include cell counts, markers of
inflammation and features of allergy. These tests will tell us about allergies your child may have and will be
used to find out if a blood test can help predict which asthma treatment will work best in toddlers.
A urine sample will be taken at visit 2 to look for markers of inflammation. This test might help predict which
asthma treatment works best in toddlers.
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 at visit 2 and by you at home during each
respiratory illness. We will teach you how to collect the mucus and provide you with supplies and storage
instructions.
Diary completion. Your child’s asthma symptoms and medication use will need to be recorded using a small
electronic diary (slightly bigger than a pack of playing cards). You must toggle through and answer questions
daily. If you do not do this task a majority of the time, your child may be asked to withdraw from the study.
The specific tests and procedures performed at each visit are listed in the table below:
Week
- 2 to - 8
0
Run-in
Visit Number
Informed
Consent
Medical
History
Full Physical
Exam
Brief Physical
Exam
Review Diary
1
4
16
Treatment 1
20
32
Treatment 2
36
48
Treatment 3
2*
3
4
5
6
7
8
+
+
+
+
+
+
+
+
+
+
+
+
+
+
Questionnaires
+
+
+
+
+
+
+
Blood Test
Urine
Test
**Nasal Mucus
Sample
+
+
+
+
+
+
**You will also obtain nasal mucus samples at home with each respiratory illness.
Telephone calls will occur every 4 weeks between treatment visits.
PARTICIPATION RESPONSIBILITIES
You will have at-home tasks to do twice a day for the entire study. You should try hard to keep appointments
and phone calls. Call the study coordinator if you must change your appointment. Study tools and all study
Page 4 of 9
IRB Form 02242012
Version Date: 07/20/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
medications (used and unused) should be brought with you to every study visit. They should not be thrown
away.
The study medications 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 and should be kept out of the reach of other children or people
who cannot read or understand the labels on the medications.
Uncontrolled wheezing can be life threatening. If asthma symptoms worsen you should immediately call the
study coordinator [insert phone number], not your primary care provider. If serious asthma symptoms develop
contact the closest emergency room (ER)/Urgent Care immediately.
What are the Risks?
Being part of this study may involve some risks or discomforts. Any medication or procedure may cause side
effects. The most common side effects for study medications and procedures are listed below.
Please make sure that the study team knows about all of your child’s drug allergies. Serious allergic reactions
to the drugs used in this study are rare. If an allergic reaction occurs, 1) stop the drug immediately, 2) get
emergency medical care, and 3) contact the study coordinator [insert phone number].
RESPIRATORY SYMPTOM WORSENING: Your child’s asthma treatment might have changed when they
joined this study. In addition, it will change between 3 different treatment options during the study. It is possible
that changing your child’s asthma medication might worsen their asthma. Your child may have more asthma
symptoms during the study that would need to be evaluated and possibly treated with additional non-study
medications.
Study Medications
FLUTICASONE PROPIONATE (FLOVENT®): Research studies of fluticasone in children less than 5 years of
age have shown no meaningful differences in the rate of adverse effects compared to placebo when given for
12 weeks. The biggest concern for young children is the possible effect on growth. ”Catch-up” growth after
stopping fluticasone has not been fully studied. The growth of all children in the study will be carefully
measured at each study visit. Headache (11%), throat irritation (8%), upper respiratory inflammation (2%),
sinusitis (6%), hoarseness (2%), and oral candidiasis (2%) are also possible adverse effects of fluticasone.
MONTELUKAST (SINGULAIR®): In research studies, the most frequent adverse effects of montelukast
included worsening asthma, sore throat, and fever. These events were similar to placebo and other asthma
therapies and did not change or worsen with long-term use. In children under 5 years of age, the most
common adverse effects with a frequency of about 2% include fever, cough, abdominal pain, diarrhea,
headache, rhinorrhea, rash, ear pain, and conjunctivitis. Montelukast has not been shown to have a significant
effect on growth velocity in children.
ALBUTEROL: Albuterol may cause the heart rate to increase and your child to feel shaky, sick to the stomach,
nervous, lightheaded, or dizzy. Your child probably already uses albuterol so you may be familiar with how
he/she responds to this medication.
PREDNISOLONE: Short courses of oral corticosteroids can cause wakefulness, fussiness and an increased
appetite. 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 long-term side effects are not expected to occur in
this study because, if prednisolone is given, it will only be for only 4 days at a time.
Page 5 of 9
IRB Form 02242012
Version Date: 07/20/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
Procedures
QUESTIONNAIRES: Questionnaires are not tests. There are no ‘right’ or ‘wrong’ answers. There are no known
risks to answering the questions. You can skip any question that makes you uncomfortable.
BLOOD SAMPLING: The risks with taking blood include possible pain from the skin puncture, as well as
bleeding or bruising of the skin. There is a rare risk for infection at the place of puncture of the skin. Dizziness,
lightheadedness, 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 of the needle poke. 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. 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 to blow their nose, there are no risks involved. Other
children will be sampled using a nasal swab (like a Q-tip). 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.
MEDICAL HISTORY, PHYSICAL EXAMS AND PARTIAL PHYSICAL EXAMS: There are no risks associated
with these procedures.
OTHER: There is always the risk of having a previously unknown side effect. You will be told of any major new
findings. The study doctor 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?
Your child will receive physical examinations at no cost during the study. Your child may benefit by receiving
frequent asthma check-ups during the study. However, you and your child are not expected to benefit in the
long-run from being in this study. This study may help other young children in the future because we will learn
more about personalizing asthma treatment in this age group.
Will my child be paid for participation in the study?
You will be paid a total of $600 if your child completes the study. If you withdraw your child before the final visit,
your payment will be prorated for only study visits and phone calls that have been completed (see below). If
you receive more than the minimum reporting requirements as set by the Internal Revenue Service (>$599 in a
calendar year) for participating in the INFANT and AVICA studies, Emory University must report this income to
the IRS and will issue you a 1099 form. We will ask that you provide your social security number for this
purpose. You will be responsible for reporting this compensation when you file your tax return. Non-monetary
incentives such as small toys may be given to children at each visit.
$80 for completion of the first visit
$100 for completion of the randomization visit (visit 2)
$25 for completion of visits 3,4,5,6,7,8
$25 for bringing the electronic diary and study medications to visits 3, 4, 5, 6, 7, 8
$20 for completion of each of 6 phone calls
Page 6 of 9
IRB Form 02242012
Version Date: 07/20/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
Will there be compensation for injury?
In the event that you or your child is physically injured as a result of participating in this research, emergency
care will be available. You will, however, be responsible for the charges for the emergency care. There is no
commitment to provide any compensation for research-related injury. You should realize that you have not
released this institution from liability for negligence. Please contact the investigator, Anne M. Fitzpatrick, PhD
at 404-727-9112 if you are injured or for more information.
Are there any alternatives?
There are many treatments available for asthma and/or wheezing. Your child does not have to take part in this
study to get treatment for his/her asthma. 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.
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 Food and Drug Administration, the Office for Human Research Protections, the Emory
Institutional Review Board, the Emory Office of Research Compliance, the Office for Clinical Research, and the
Clinical Trials Audit & Compliance Office. 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.
Study records can be opened by court order. They may also be produced in response to a subpoena or a
request for production of documents.
There is a Certificate of Confidentiality for this Study:
We will do everything we can to keep others from learning about your participation in the research. To further
help protect your privacy, the investigators have obtained a Confidentiality Certificate.
What the Certificate of Confidentiality protects:
The National Institutes of Health has given this study a Certificate of Confidentiality. Emory would rely on it
avoid giving out study information that identifies you. For example, if Emory received a subpoena for study
records that identify you, 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 does not prevent you or someone other than you from making disclosing your information. The
Certificate also does not prevent Emory from releasing information:
 to state public health offices about certain infectious diseases
 to law officials if child abuse has taken place
 to prevent immediate harm to you or others
 to the study sponsor as part of the research
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.
Page 7 of 9
IRB Form 02242012
Version Date: 07/20/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
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 or procedures. These useful
study results will/will not be placed in your Emory Healthcare medical record. Anyone who has access to your
medical 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.
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 and urine tests.
We may need to contact your child’s personal doctor during the study to discuss study findings. We may also
ask you to contact your child’s personal doctor if your child is having medical problems that are unrelated to the
study. You must provide us with the contact information for your child’s personal doctor, so that we may
contact them in the event of a medical emergency.
Are there any costs?
All study tests, study medications, study visits and phone calls are provided without cost to you, your
healthcare provider or insurance company. 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 study will need to be
paid for by you or your health care insurer.
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, and you will be asked to return
all study related items.
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.
Request Permission for Future Contact
Please initial the correct box below.
1. May we contact you for future studies conducted by the [insert
institution] or AsthmaNet?
If yes, we may need to look at your child’s Protected Health Information
(PHI) to check for study eligibility.
2. May other [insert institution] physicians conducting asthma research
contact you?
If yes, your child’s PHI may be shared with those physicians.
Page 8 of 9
IRB Form 02242012
___ Yes
___ No
___ Yes
___ No
Version Date: 07/20/2012
Study No.: IRB00057906
Emory University IRB
IRB use only
Document Approved On: 7/18/2012
Project Approval Expires On: 7/17/2013
Contact Information
Contact Jennifer Dodds at 404-727-5176:
 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.
If you are a patient receiving care at Children’s Healthcare of Atlanta and have a question about your rights,
please contact Kristine Rogers, Director of Clinical Research at 404-785-1215.
Consent
I am the parent/legal guardian of the child named below. I have read the information in this consent form, reviewed
any questions, and I voluntarily agree to have my child participate in this study. I have received a copy of this
consent form.
Name of Subject
Signature of Person Conducting Informed Consent Discussion
Date
Time
Date
Time
__________________________________________________________
Name of Person Conducting Informed Consent Discussion
Signature of Legally Authorized Representative
Authority of Legally Authorized Representative or Relationship to Subject
Page 9 of 9
IRB Form 02242012
Version Date: 07/20/2012