Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
Emory University and Children’s Healthcare
Consent to be a Research Subject
Version 3.0, May 20, 2011
Title: Vitamin D add-on therapy enhances corticosteroid responsiveness in Asthma (VIDA)
Principal Investigator: Anne M. Fitzpatrick, PhD, Karen DeMuth, MD
Sponsor: National Institutes of Health (NIH), National Heart, Lung and Blood Institute’s AsthmaNet
Introduction
You are being asked to join a research study about vitamin D and asthma. You are being invited because you
are healthy other than having asthma. 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. A study coordinator will talk
with you about other entry requirements. Joining this study is voluntary. If you decide not to join, your
relationship with Emory University and your health care provider will not be affected in any way.
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.
Who is the Sponsor of the Study?
AsthmaNet is the sponsor of this study. AsthmaNet is funded by the National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI). The Network’s purpose is to develop and carry out asthma
related studies. There are 16 AsthmaNet research sites across the United States doing this study. Emory
University is one of them.
How many people will be enrolled?
As many as 1600 people may need to be screened so that about 400 people across the nation can be
randomized in this study. Up to 50 eligible people can be randomized at each research site.
What is the purpose of the study?
The purpose of this study is to find out if taking vitamin D in addition to an inhaled steroid called Alvesco®
(ciclesonide) will help prevent worsening asthma symptoms and asthma attacks.
We know that some people’s asthma remains uncontrolled even when they regularly take inhaled steroids.
There are many possible reasons for this. One reason might be that inhaled steroids do not work as well in
people with low vitamin D levels. This could be related to the role vitamin D might play in reducing
inflammation. Airway inflammation can worsen asthma.
Page 1 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
Brief study overview
This study has 11 visits across 35 weeks (about 9 months). The study visits will be from 45 minutes to a few
hours long. The purpose of the study is to find out if taking vitamin D in addition to an asthma controller
medication helps to prevent worsening of asthma symptoms and asthma attacks. If you experience worsening
of your asthma during the study, you may be asked to come to the clinical site for one or more extra safety
visits.
If you agree to be in the study and are eligible, you will be asked to take an FDA (US Food and Drug
Administration) approved inhaled steroid called Alvesco® twice a day. You will also take either active vitamin D
or a look-alike placebo (inactive substance) once each day. About half of the people in the study will be on
active vitamin D and half will be on placebo. The inhaled steroid will always be active drug but the dose may
lessen during the study and the dosing schedule may change to once a day. Everyone will take a 5-7 day
course of prednisone (a steroid) between visits 3 and 4 to see how good your breathing tests can get on oral
steroids. The study includes 5 or 6 needle sticks for blood tests, allergy skin testing, and body measurements.
The blood tests are taken for vitamin D, calcium and creatinine (a measure of kidney function) levels, and an
optional genetic testing sample. Everyone will provide a urine sample 6 times to check for urine calcium and
creatinine levels, and women will have up to 4 urine pregnancy tests. Breathing tests and questionnaires will
happen at all but the first visit. Up to 3 methacholine challenges (a breathing test for asthma) and 2 sputum
samples will be done. You will be asked to perform simple study tasks at home every day like taking peak flow
measurements, taking your medications, and answering questions about your asthma symptoms.
There are many drugs that work well in treating asthma. You do not need to be in a study to get asthma
treatment. If you decide to join this study, you can change your mind or stop at any time.
What does my participation involve?
AsthmaNet Registration.
Before you enroll in an AsthmaNet study, you must first be entered into the AsthmaNet Registry. This Registry
has been set up to collect basic background information that, for the most part, should not change over time.
Collected information is limited to: your initials, date of birth, gender, and race/ethnic identification. Your
Registry information will be coded with a unique AsthmaNet identification number. No information that directly
identifies you 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 participation in multiple AsthmaNet studies over time
so that this can be accounted for in certain types of data analyses.
Your agreement to provide the information required for the AsthmaNet Registry is voluntary. However, if you
choose not to provide it, you cannot be screened for or enrolled in any AsthmaNet study. Once you consent to
be entered into the Registry, your 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 participation in
AsthmaNet studies. Registration happens before or during your first study visit (visit 0).
Screening. In order to determine whether or not you meet the requirements for the study, you will need to
complete two screening visits. The pre-screen visit (visit 0) will be short (around 45 minutes). This visit
involves reviewing this consent form, taking a brief medical history to gather information about your current and
past health, and drawing a blood sample to measure your vitamin D level. People whose vitamin D levels are
in the normal range are ineligible for the study. People whose vitamin D levels are below the normal range are
eligible to continue. You will not be told your exact vitamin D level; however, you will be informed if you are
eligible or ineligible.
If you are eligible after completing visit 0, you will be invited to return for visit 1. This screening visit includes a
physical examination, a long medical history, questionnaire completion, spirometry with bronchodilator (quickPage 2 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
acting medication that opens your windpipes like albuterol), additional blood tests, and a urine test. Please see
below for further details about these tests. Your eligibility for the study will be assessed more completely. If
you are eligible at visit 1, you will be invited to return for visit 2. At visit 2, if you meet additional requirements,
you will enter the main study and start study medications.
It will take approximately 2-3 weeks to complete the screening visits. The main study is 33 weeks long starting
with visit 2.
Clinic Procedures. Please refer to the table below. Screening (Scr) visits are visits 0 and 1. You will be
notified within a few weeks of visit 0 whether you qualify to return for a visit 1.
Visit
Week
0
Scr
Steroid inhaler dose
taper
Informed consent
X
Brief medical history
X
Full medical history
Long physical exam
Short physical exam
Body measurements (ht,
wt, waist, hip, neck)
Skin color test
Allergy skin testing
Genetics blood sample
1
2
3
4
5
6
Scr
0
4
5
11
17
Page 3 of 14
IRB Form 101110
8
9
10
25
29
33
X
X
X
X
X
X
X
X
TF***
X
X
X
X
X
X
**
Vitamin D level
(blood test)
Blood calcium and
creatinine levels
Urine calcium and
creatinine tests
Urine pregnancy test
Spirometry
Maximum levalbuterol
reversal test
Methacholine challenge
Sputum collection
Questionnaire
completion
Cold questionnaire
distribution/instruction
Review diaries
Review medication use
Satisfaction
questionnaire
Prednisone burst
7
2
1
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X*
X*
X
X
X*
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X+
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
*
You will be asked to complete spirometry, a urine pregnancy test (for women of child-bearing potential),
and a methacholine challenge test at visit 2 only if you did not show reversal to levalbuterol at visit 1. You
must either reverse to levalbuterol or respond to the methacholine challenge to qualify for the study.
**
The genetics blood sample is optional and may be postponed until the time of the vitamin D blood test at
visit 6, if you wish.
*** Additional visits to the clinical site will be required if you experience worsening of your asthma between
regular study visits.
+
Approximately 200 people will undergo sputum induction at visit 6. Only those whose sputum sample at
visit 3 was of good quality will be eligible to have the sputum induction at visit 6.
Medical history. You will be asked about your current and past health, and about prescription and over-thecounter medications, vitamins and nutritional/herbal supplements you use.
Physical examination. The extent of the physical examination (whether it is just a blood pressure and listening
to your lungs and heart or all of the tests) will depend on the study visit. A thorough examination will be done at
the beginning of the study (visit 1) to make sure that it is safe for you to participate. The examination may
include listening to your lungs and heart, looking into your ears, nose and throat, and measuring your height,
weight, blood pressure and heart rate.
At certain visits we will also measure your waist, neck, and hips.
At certain visits we will also measure your skin pigmentation (skin color). Vitamin D is naturally absorbed from
the sun through your skin and is affected by skin pigment. Your skin pigmentation will be tested using a device
for measuring light intensity. The device will be placed next to the skin on your exposed forearm, upper inner
arm, forehead and abdomen to get readings each time.
Vitamin D level (blood test). You will have a needle stick for vitamin D levels at 4 study visits. The first vitamin
D level is measured at the pre-screen visit (visit 0) to determine if you are eligible for the study. If you are
eligible and enroll in the study, you will have three additional vitamin D levels measured to monitor your safety.
You will not be told your exact vitamin D levels at any point in the study. However, if you have a high value
during the study, you will be told to stop your study capsules and we will advise you to speak with your primary
care physician for follow-up. A vitamin D level requires about 1 teaspoon of blood each time.
Calcium and creatinine levels (blood tests). You will have a needle stick for serum calcium and creatinine
levels at visit 1. These tests help us identify people who are at risk for kidney stones. The risk of kidney
stones in these individuals may be increased with high levels of vitamin D. These individuals will not be
eligible to continue in the study. Additional serum calcium tests may be required during the study to monitor
your safety as explained below. These tests require about 1 teaspoon of blood each time.
Urine test. A urine sample will be required to measure urine calcium and creatinine ratio at 6 study visits. This
test will tell us if you have abnormally high levels of calcium in your urine which might be from too much vitamin
D. If your urine level is high, you will be asked to drink more fluids and the test will be repeated about a month
later. If your repeat urine level is still too high, you will be asked to stop taking the study capsules temporarily
and additional blood calcium and vitamin D level tests will be done. If either of the blood tests is high, you will
be told to stop taking the study capsules for the rest of the study. If neither blood test is high, you will be told
to resume taking your study capsules. It is unlikely that anyone will have a vitamin D level that is too high
causing calcium to be found in their urine.
Allergy skin testing. Drops of common allergens like dust mite, cat, dog, tree, grass, and molds will be placed
on the soft part of your forearm. Your skin will be scratched or pricked at each drop. Twenty minutes later a
Page 4 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
study coordinator will look for redness or swelling (like a mosquito bite) where the tests were done. Redness
and swelling means that you are allergic to what was in that drop.
Urine pregnancy test. Females must not be pregnant or become pregnant during the study. If you are a female
and can become pregnant you will have a urine pregnancy test 4 times during the study. You will know the
pregnancy test results within minutes. You cannot continue in the study if the pregnancy test is positive. If you
are able to get pregnant (that is, you are female and are not surgically sterile or post-menopausal), you must
use birth control during the entire study. Acceptable birth control methods include: abstinence, birth control
pills, diaphragm, intra-uterine device (IUD, IUS), Depo-Provera, NuvaRing, birth control patches, single or
double barrier methods (condom plus foam/jelly) or surgical sterility.
Spirometry. You will wear a nose clip and breathe out forcefully into a machine. The machine measures how
much air you blow out and how fast it comes out. This test tells us how well your lungs are working. Your
asthma must be within a certain range to qualify for the study.
Maximum albuterol reversibility. You will perform spirometry, take 4 puffs of levalbuterol (Xopenex®) to open
your airways, and repeat spirometry 15 minutes later. This test measures improvement in your breathing. If
you show a 12% improvement in spirometry, you will be considered eligible for the study. The test will
continue by having you take 2 additional puffs of levalbuterol and repeating spirometry 15 minutes later to see
if your airways have opened as much as possible. If not, you will be given 2 additional puffs of levalbuterol and
will repeat spirometry again. You will receive at least 6, but no more than 8, total puffs of levalbuterol.
Methacholine challenge test. Methacholine is a drug that you breathe in that can cause narrowing of the
airways and might make you feel like you are having a mild asthma attack. This test will tell us how quickly
your airways narrow as you breathe in gradually increasing doses of methacholine. Spirometry will be
performed after each dose of methacholine to measure your airway change. The test will be stopped when
your breathing tests decrease by at least 20% or you have been given the highest dose of methacholine. At the
end of the challenge, you will be given levalbuterol to reverse any symptoms.
Sputum collection. You will be asked to breathe in a salty mist for up to 12 minutes and will be asked to cough
deeply and vigorously every two minutes in order to bring up a sample of sputum (mucus) from your lungs. We
will look at your sputum in the laboratory to see if inflammation is present.
You will be asked to perform sputum collection at visit 3. About half of the participants (approximately 200) will
be asked to repeat sputum collection at visit 6. Only those whose visit 3 samples are of good quality will be
asked to perform sputum induction at visit 6.
Review peak flows/e-diary entries and medication use. A study coordinator will review your peak flows and
symptom scores collected with your electronic peak flow monitor/e-diary (spirotel® device). The purpose is to
check on your asthma symptoms and asthma control since your last visit. The coordinator will also check your
study medication use. These steps are to ensure that you are doing as asked with the at-home study
procedures. These are described in detail below.
Questionnaires. You will be asked to complete many types of questionnaires. Most questionnaires will tell us
how you feel about your asthma, your asthma medications, and how asthma affects your life. You will also be
asked about your vitamin D intake through the food you eat, sun exposure, nasal symptoms and
socioeconomic status (your household income, number of people supported by the household income, and
educational level). If you get a cold during the study, we will also ask you to complete a cold questionnaire.
Lastly, when you leave the study you will be asked to complete an optional anonymous questionnaire (your
name and study ID are not recorded) that measures your level of satisfaction with being in the study.
Page 5 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
Study Medications.
Vitamin D study drug. Vitamin D helps the body in many ways including maintaining strong bones, helping
muscles and nerves work and, possibly, reducing inflammation. The major source of vitamin D is from sunlight,
and you can also get vitamin D from your diet. You do not need to change your diet or sun exposure habits for
this study, and you can continue taking a vitamin D supplement (either by itself or in a multi-vitamin) up to the
current recommended daily dose, if you wish. Please do not begin any vitamin pill, capsule, or liquid containing
vitamin D or cod liver oil after you join the study.
The study drug you will receive in this trial is in the form of a soft capsule. The capsules will contain either
vitamin D3 (cholecalciferol) or placebo (inactive substance). You will be randomized (decided like the flip of a
coin) to receive either vitamin D or placebo capsules. Your chance of being assigned to vitamin D is 50/50 (an
even chance). Whether you are taking vitamin D or placebo will be kept a secret. None of the study doctors,
coordinators, or you will know if your capsules contain vitamin D or placebo. This information can be found
out if needed in the case of an emergency.
During this study there will be one or more periods during which you may receive placebo capsules. It is
important for the success of the study that you are unaware of which study periods these are.
Everyone will receive a one-time dose of either 100,000 IU of vitamin D or placebo. After you take the one-time
dose as instructed, you will be asked to take a daily capsule that contains either 4,000 IU of vitamin D or
placebo.
In November 2010, the National Academy of Sciences Institute of Medicine set the upper level intake for
vitamin D at 4,000 IU per day for adults. Recent studies show that this level could safely be increased to
10,000 IU per day, well above our daily dose of 4,000 IU per day.
The study drug will be given to you in a container that is child resistant. The container will have a special cap
that keeps track of when the container has been opened. Even though the special cap is childproof, you still
should store the study drug out of the reach of children to prevent accidental overdoses.
Inhaled steroid ciclesonide (Alvesco®) is considered an asthma ‘controller’ medication. It works to reduce
airway inflammation and is FDA approved for the treatment of asthma. The study inhaler will be open-label (not
a secret) active medication for the entire study. Everyone will begin on the same dose of the inhaled steroid
and the dose will be tapered (reduced) at two points during the study. At 80 mcg per puff, you will be asked to
take 2 puffs twice a day, then 2 puffs once a day, and finally 1 puff once a day. We will follow you closely so
that your asthma is stable and it is safe to proceed with each dose taper. If you do not meet the asthma
stability definition, you will not have one or both of the dose tapers. You will be allowed to continue in the study
even if you cannot have your dose tapered.
Rescue medication levalbuterol (Xopenex®) is an FDA approved short-acting ‘rescue’ bronchodilator
medication that helps open the airways and reduce asthma symptoms. You can use it as needed during the
study to treat asthma symptoms.
Oral steroid prednisone. At visit 3 you will begin 5-7 days of prednisone (40 mg per day). This prednisone
course will end at visit 4. The purpose of the prednisone course is to find out how good your breathing can get.
At visit 4 you will be given a supply of prednisone to keep at home. This prednisone can only be used if you are
having a bad asthma attack (asthma exacerbation) AND study personnel or a treating physician tells you to
begin taking it. You will be given a home rescue plan that helps you know if you are having an asthma attack
and should call in for instructions.
Page 6 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
Peak flow monitoring. You will be asked to check your peak flow twice every day during the study. The
electronic peak flow monitor is combined with an e-diary in the spirotel® device. The study will give you a
spirotel® device to use for the study, but it must be returned at your last visit. Peak flow data will be stored in
the device until your next study visit when it will be transferred to a study database and reviewed with you.
E-diary. Before you use the spirotel® device to take your peak flow in the morning or in the evening, it will
present you a series of questions about your asthma symptoms and rescue medication use. You will be
expected to answer these questions twice a day. Data will be stored in the device until your next study visit
when it will be transferred to a study database and reviewed with you.
Inhaled steroid (Alvesco®). You will begin by taking 2 puffs twice each day. At visit 6 you may be instructed to
decrease the Alvesco® to 2 puffs once a day if you meet certain safety conditions. At visit 8 you may be
instructed to decrease the Alvesco® to 1 puff once a day if you meet certain safety conditions. You will be
given clear instructions at each visit as to what dose to take between visits. DO NOT decrease the medication
on your own; only do so if your study coordinator instructs you to.
A DOSERTM device will be used to monitor the number of puffs you use from your Alvesco® inhaler each day.
Information stored in the DOSERTM will be reviewed at each clinic visit to ensure that you are following study
dose instructions.
Study drug (placebo/vitamin D). You will be asked to take one capsule each day in the morning. Data from
the special cap on the container will be uploaded and reviewed at each clinic visit to ensure that you are
following study dose instructions.
ARE THERE ANY RISKS?
Study medications.
Active vitamin D. Too much vitamin D can cause nausea, vomiting, poor appetite, constipation, weakness and
weight loss. Less frequently, too much vitamin D can cause confusion, disorientation, problems with heart
rhythm, and kidney stones or kidney damage. As discussed above, the doses of vitamin D used in this study
have been well studied in people and the risk of having dangerously high levels in the blood is very small.
We will monitor your blood levels of vitamin D and your urine calcium and creatinine ratio throughout the study
to ensure that you do not have too much vitamin D.
Vitamin D may interact or interfere with some medications. It is important that the study coordinator has a
complete list of all of the prescription and over-the-counter medications and supplements that you take. Any
changes in your medications that occur during the study should be reported to study personnel immediately.
Placebo. Placebo is an inactive substance that is unlikely to cause any side effects. Only the vitamin D
capsules might be a placebo.
Changing your asthma medications. Your asthma treatment might change when you join this study. You will
have to stop taking your regular asthma medications and start taking the study inhaled steroid inhaler
Alvesco®. It is possible that changing your asthma medications might worsen your asthma.
Inhaled steroid (Alvesco®). Inhaled steroids are the most common medications used for asthma control. They
can produce hoarseness, sore throat, and yeast infections of the mouth or throat (thrush or oral candidiasis) in
up to 1% of people taking the medication. Less often, and usually only when taken at high doses for long
Page 7 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
periods, inhaled steroids can cause adrenal gland suppression (a change in some of the hormones your body
makes), weight gain, bruising and elevated blood sugar.
At visit 2, you will be put on a standard dose of Alvesco® (80 mcg/puff, 2 puffs twice a day). The dose will be
reduced at two later points during the study if you meet certain safety conditions. The dose will be reduced in
half at visit 6 and then in half again at visit 8. This means that you may be taking a quarter of the original dose
during the last part of the study. We will monitor you closely to make sure your asthma is not getting worse. We
will not reduce your inhaled steroid dose if your asthma is not stable.
It is important that you perform your peak flows and complete your e-diary questions as instructed. This will
help us know if your asthma is stable. You will have an action plan tailored specifically for you. Your action plan
will have instructions to contact the study site if you hit your “red” zone or if you feel that your asthma is getting
worse.
Oral prednisone. The most common risk from taking prednisone is heartburn. The risk is less if the medicine
is taken with food. Other common side effects include increased appetite (the “munchies”), nervousness,
restlessness, or trouble sleeping. Less common are headache, increased sweating, increased hair growth, or
increased blood sugars, which you might notice as having to pass urine very frequently or as increased thirst.
More side effects are reported with high dose, long term use of prednisone. We do not expect you to have
those side effects because you will not take a high dose of prednisone and you will take the medicine for short
periods. A very uncommon side effect has been reported with prednisone in which the hip bone deteriorates.
While this effect tends to be related to longer prednisone use, it has been reported after short courses. The
occurrence of this side effect with short term use is very rare.
Levalbuterol (Xopenex®). You most likely already use this drug, or one like it such as albuterol, as part of your
usual care. It might cause tremors, nervousness, dizziness, difficulty sleeping, headache, rapid or irregular
heartbeats, drying and irritation of your mouth, sore throat, upset stomach and coughing. If such symptoms
occur, they usually go away within a short time and do not require treatment.
If you are a woman: to protect against possible side effects of the study drug, women who are pregnant or
nursing a child may not take part in this study. If you are a woman of childbearing ability, you and the study
doctor must agree on a method of birth control to use throughout the study. If you think that you have gotten
pregnant during the study, you must tell the study doctor immediately. Pregnant women will be taken out of
the study.
If you will be taking the study drug home, keep it out of the reach of children or anyone else who may not be
able to read or understand the label. Do not let anyone else take the study drug besides you.
Study procedures.
Blood drawing. The needle stick for taking a sample of blood may cause a small amount of pain or leave a
bruise or “black and blue mark.” Rarely, people faint after blood drawing. Very rarely, the vein in which the
needle has been inserted may become inflamed or infected, but that can be treated.
Allergy skin testing. There may be mild pain from the needle scratch and your arm might itch or burn where the
test was done. A “mosquito bite” reaction is expected if you are allergic. This usually goes away within an
hour, although it can last longer. Hives and wheezing rarely occur. Symptoms such as itching all over your
body and swelling of your skin, tongue or eyelids occur in about 1 out of 10,000 people. Emergency care is
available to treat these rare reactions.
You will need to stop taking antihistamines (allergy medications like Benadryl, Claritin, Zyrtec) a few days
before your skin test. Your allergy symptoms may worsen during this time.
Page 8 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
Urine pregnancy test. There may be unknown risks to the fetus/unborn child if you become pregnant while in
this study. Although birth control is required, you should notify the study doctor or coordinator immediately if
you become pregnant during the study. You must stop the study if you become pregnant. There are no risks
associated with the act of taking a urine pregnancy test.
Spirometry. Spirometry might make you cough, feel short of breath or dizzy, or your chest feel tight. Treatment
with levalbuterol will be available if you need it.
Maximum albuterol reversibility testing. Taking 6-8 puffs of levalbuterol (Xopenex®) can make your heart race
or make you feel jittery. Less often it can increase your blood pressure or cause nausea or headache. These
feelings are temporary.
Methacholine challenge. The methacholine challenge is expected to make your airways “tighter.” You will likely
have coughing, chest tightness, shortness of breath and/or wheezing during this procedure. Most people
describe this as feeling like they are having a mild asthma attack. If your symptoms are severe, treatment will
be given immediately and the challenge will be stopped.
Sputum collection. Breathing in the salty mist may be irritating to your throat and chest. Some people do not
like the salty taste in their mouth and feel nauseous. This test may irritate your asthma, but this possibility is
reduced by treating you with levalbuterol (Xopenex®) before the test and by monitoring your lung function
during the test. The 12-minute test will be stopped sooner if your lung function worsens or if you choose to stop
the test.
Questionnaires. The questionnaires are not tests. There are no right or wrong answers. Complete all questions
as best you can, but you may skip a question if you feel uncomfortable answering it.
Skin pigmentation test. You will need to expose the skin of your upper inner arm and abdomen for this test.
The test itself will not cause you any pain or side effects.
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.
Benefits
This study is not designed to benefit you directly. Your asthma may improve while you are in this study but it
may not, and it may even get worse. This study is designed to learn more about the role of vitamin D in
treating asthma. The study results may be used to help others in the future.
ARE THERE ANY COSTS?
The study medications, doctor’s examinations, and study visits will be at no cost to you.
Compensation
You will be paid $1010 for completing the entire study. This includes study visits to the clinical site as well as
performing at-home tasks. At-home tasks include peak flows, taking study medications, and answering diary
questions twice a day. If you do not complete the study, you will be reimbursed for the visits you have
Page 9 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
completed (see table, below). If you need to come to the clinical site for additional safety visits during the
study, or for an early termination visit, you will be paid $10 to cover your travel expenses.
Payment schedule:
Visit
0
1
2
3
4
5
6
7
8
9
10
TOTAL
Approximate Time
45 minutes
2 hours
1 to 1 ½ hours
1 ½ - 2 hours
45 minutes
45 minutes
1 ½ - 2 hours
45 minutes
1 hour
45 minutes
1 ½ hours
Amount
$60
$110
$110
$110*
$85
$85
$85*
$85
$85
$85
$110
$1010
*
People who perform the sputum induction procedure at visit 3 or visit 6 will be paid an additional $50 (total visit
3 payment $160 and total visit 6 payment $135).
Other Treatment Outside this Study
You do not have to join this study to receive treatment for your asthma. There are many asthma treatments
available and you can discuss them with your doctor. If you want to start another asthma treatment, you must
first tell the study doctor or coordinator. The study team can discuss alternatives with you.
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.
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.
To help protect your privacy, AsthmaNet has received a Certificate of Confidentiality from the FDA. With this
Certificate the researchers cannot be forced to disclose information that may identify you, even by a court
subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The
researchers will use the Certificate to resist any demands for information that would identify you, except as
explained below.
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
Page 10 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
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 involvement in this research. If an insurer,
employer, or other person obtains your written consent to receive research information, then the researchers
may not use the Certificate to withhold that information. The Certificate of Confidentiality does not prevent the
researchers from disclosing voluntarily, without your consent, information that would identify you as a
participant in the research project in cases of suspected child abuse or intent to hurt self or others.
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
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, those things include lung function tests and chest x-rays.
In Case of Injury
Page 11 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
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.
ARE THERE ANY COSTS?
There will be no costs to you for participating in this study. You will not be charged for any of the research
activities. The study medications, doctor’s examinations, and study visits will be at no cost to you.
Withdrawal from the Study
Your decision to join this research is voluntary. You may choose not to participate. If you do decide to
participate, you may change your mind at any time without penalty or loss of benefits that you had prior to the
study. You will be told of any new, significant findings that may affect your willingness to continue. Your
decision of whether or not to join this study will not affect the quality of your medical care at this institution.
The study doctor can end your participation in the study if he/she judges it to be in your best interest or if you
do not follow the study procedures or for any other reason. In addition, the study sponsor may end the study at
any time without your consent. A full explanation for stopping your participation will be discussed with you.
If you change your mind and decide to leave the study early, we will ask you to come in for a final visit. At this
final visit we will collect all study supplies and ask you to complete questionnaires, perform spirometry, and
provide a blood sample for a vitamin D level.
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
WHAT IF I HAVE QUESTIONS?
Please take as much time as you wish to think over joining this study. Please ask questions about any part of
this study that is unclear. We will try to answer fully all questions you may have prior to, during, and following
the study.
If you have questions about this research, please contact us.
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:
Page 12 of 14
IRB Form 101110
Study No.: IRB00047710



Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
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.
Page 13 of 14
IRB Form 101110
Study No.: IRB00047710
Emory University IRB
IRB use only
Document Approved On: 1/11/2012
Project Approval Expires On: 1/10/2013
CONSENT AND AUTHORIZATION TO PARTICIPATE IN THE VIDA 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.
Name of Subject
Signature of Subject
Date
Time
Signature of Investigator or Person Conducting Informed
Consent Discussion
Date
Time
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IRB Form 101110