IRB NUMBER: 14-14224
IRB APPROVAL DATE: 09/04/2018
IRB EXPIRATION DATE: 09/03/2019
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
CONSENT TO PARTICIPATE IN A RESEARCH STUDY
Study Title: Allergen Challenge for Evoked Phenotypes in Asthma (ACE Study)
This research study is funded by the National Institute of Allergy and Infectious Diseases
(NIAID), which is one of the National Institutes of Health (NIH).
YOUR PARTICIPATION IS VOLUNTARY
This is a medical research study. To keep the information in this form simple we shall refer to a
medical research study as a “study”. The study will only include people who choose to take part.
Your study doctor, Prescott Woodruff, MD, MPH, from the Department of Medicine, Division of
Pulmonary, Critical Care, Allergy and Sleep Medicine, or one of his designated research staff
from the Airway Clinical Research Center will explain the study to you. Dr Woodruff or one of
the study staff will answer any questions you have. Only you can decide if you want to take part
in this study. You should only make your decision after you have read the entire form. Take your
time to make your decision about participating. You may discuss your decision with your family
and friends and with your health care team. Even after you have signed this study consent form
you can change your mind and decide not to participate in the study. You do not have to give a
reason. You will be given a copy of this consent form for your records.
You are being asked to take part in this study because you have asthma and are allergic to cat
dander and/or dust mites. You may also take part in this study if you do not have asthma.
Why is this study being done?
Asthma is a disease of the lungs that is sometimes caused by an allergy, such as being allergic to
house dust or cat dander. When a person with asthma breathes an allergic substance ( “an
allergen”) into their lungs, the lung responds by making certain substances, called mediators.
These mediators can cause inflammation and make certain blood cells travel into the lung. The
purpose of this study is to study these mediators and blood cells after your lungs are exposed to
an allergen (the substance that causes an allergic reaction). This may help us to better understand
how to treat asthma.
This study involves placing a few drops of a liquid containing either cat dander or dust mite into
your lungs. The allergen liquid that is used in this study is approved by the U.S. Food and Drug
Administration (FDA) for allergy skin prick testing and allergy shots. However, it is not
approved by the FDA for use in the lung. We have obtained specific approval by the FDA to use
the allergen liquid, called extracts, in this study. Therefore, the allergen extracts when used in
this study are considered experimental.
How many people will take part in this study?
A total of 38 people will complete this study. Approximately 26 people with asthma and allergies
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to cat dander and/or dust mite, approximately 6 people without asthma but have allergies to cat
dander and/or dust mite, and approximately 6 people without asthma and no allergies.
What will happen if I take part in this research study?
Please keep in mind how the study tests and visits described here will affect your work and
family schedules. Some tests may be uncomfortable. Ask the study doctor if you have any
questions about the tests and procedures for the study.
Study Procedures

Exhaled nitric oxide testing: Nitric oxide is a chemical your lungs make more of when they
are irritated or inflamed. You will blow air from your lungs into a special machine. This will
measure the amount of “nitric oxide” that you breathe out.

Spirometry: You will have your lungs tested by breathing into a machine. This test is to see
how well your lungs are working. The results of this test may prevent you from continuing in
the study.

Methacholine challenge testing: This test is often done by asthma specialists to confirm that
someone has asthma. You will inhale a medication called methacholine in the form of a mist.
If you have asthma, the methacholine will cause the airways of the lung to narrow. If you do
not have asthma, you might not feel any change in your airways. Your breathing will be
measured before the methacholine test is started and after each solution. The amount of
methacholine that you inhale will increase a little bit each time. If your lung function drops
more than the pre-set level, the test will be stopped. You may have mild asthma symptoms
during this challenge. These symptoms usually go away on their own in 15-45 minutes. The
staff will give you albuterol at the end of the challenge to make the symptoms disappear
quickly. This test will be performed by a trained professional, and a doctor will be available
at all times.

Allergy skin prick testing: Skin prick tests are done by placing a drop of liquid containing
an allergen on the forearm. The skin is pricked through the drop with a plastic applicator.
Twenty minutes later, your skin will be inspected for a red bump and itching. You will be
tested to 12 different allergens.
o If you are allergic to cat dander and/or dust mite allergen, we will ask you to do a
second type of allergy skin testing called quantitative allergen skin prick testing.
The description of this test is below.
o If you have asthma and are not allergic to cat dander or dust mite allergen you can
not continue in the study.
o If you do not have asthma you may be eligible for the study whether or not you
are allergic to cat dander or dust mite allergen.

Quantitative allergen skin prick testing: This test is only done if you have a positive skin
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test to cat dander and/or dust mite. This testing will show just how allergic you are to either
cat dander or dust mite allergen. If you reacted positive to either cat or dust mite on the
previous skin prick test described above, we will choose that allergen that gave the positive
response (cat or dust mite) to use in this next phase of testing. If you reacted positive to both
cat and dust mite on the previous skin prick test, we will choose to use cat allergen for this
next phase of testing. A series of skin prick tests will be done on your arm using different
strengths of either cat dander or dust mite allergen. We will start with the same strength that
we used on the first skin test but we will also prick your skin with (5 or 6) lower doses. This
way, we will find out your “threshold” level of sensitivity (the lowest concentration of
allergy extract that causes you to have a positive skin test).
The “threshold” level of sensitivity will then be confirmed on your opposite arm. We will
repeat the threshold concentration and the concentration above and below this threshold
concentration level. The results from this test will determine the dose of allergen that will be
used for the test in your lungs. To ensure you do not experience a delayed severe allergic
reaction, you will be kept in the research clinic for 1-2 hours after your quantitative allergen
skin prick testing is completed.

Buccal swabs: You will have the inside of your cheek rubbed with a cotton swab to collect
cheek cells that will be used to measure how your body’s allergy cells react.

Blood draw (venipuncture): You will have blood drawn at each visit. Up to approximately
70mL (5 tablespoons) of blood will be drawn.
We will do some standard blood tests that will be made part of a limited medical record here
at UCSF, including a complete blood count. We will collect blood for DNA and we will also
check for certain proteins in your blood. These proteins will let us know if we will be able to
see the specific allergy cells in your lungs that we want to study. We will also perform a
blood test using your serum (one component of your blood), which will help measure how
allergic you are to cat dander and dust mite. If you did not have any positive test result during
qualitative skin prick testing, this blood test will also help us choose which allergen (cat
dander or dust mite) will be used during the Segmental Allergen Challenge.
All of the blood can usually be collected in one stick. However, if the blood samples are lost,
damaged, or need to be repeated, we may ask you for additional samples.

Bronchoscopy: A bronchoscope is a flexible tube that allows a doctor to see into your lungs
and takes samples of tissue or cells. The bronchoscope, which is about the thickness of a
pencil (1/4 inch), will be passed through your mouth, between your vocal cords and out into
your lungs.
A bronchoscopy is a medical procedure performed by lung specialists to diagnose lung
diseases. In this study, bronchoscopy is an experimental procedure collect different samples
from the lungs. A lung specialist (who routinely performs this bronchoscopy procedure to
diagnose lung disease) will perform the two bronchoscopies, one for segmental allergen
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IRB EXPIRATION DATE: 09/03/2019
challenge and the other for collection of lung secretions. Both bronchoscopies will be
performed in the ACRC Bronchoscopy Suite.
You will have soft rubber tubes placed in your nostrils so that you can be given extra oxygen,
Your heart rate, heart rhythm, blood pressure, and oxygen saturation will be monitored.
Lidocaine will be sprayed, to the back of your throat to numb your gag response. An
intravenous line (or a small plastic tube) will be inserted into a vein in your arm. You will be
given medication through the intravenous catheter. You may receive fentanyl (a painkiller
and suppresses coughing) or midazolam (makes you less nervous). This is called conscious
sedation. Almost everyone who has a bronchoscopy performed chooses to receive fentanyl
and midazolam. If you would prefer having the bronchoscopy performed without the
sedation medications of fentanyl and midazolam, please discuss this with the study doctor.
Bronchial wash - Once in the lungs a lavage or a “bronchial wash” will be done. 10
teaspoons (50 mL) of salt water at body temperature will be put into the lung and
immediately removed by gentle suction through the bronchoscope. This will happen three
times.
Bronchial brushing - During “bronchial brushing” a small brush will be rubbed gently against
the walls of the bronchial tube. Up to six bronchial brushings will be performed.
Bronchial biopsy (tissue samples) - Prior to collecting pieces of tissue samples, the
bronchoscope will be moved to another area of the left lung and up to eight tiny (1/8th inch)
pieces of tissue lining the bronchial tube will be removed using small metal forceps. If a
sample collected is not acceptable or not adequate for analysis, another sample will be
collected so long as the physician performing the bronchoscopy decides that it is safe to do
so.
Segmental Allergen Challenge - 1/2 teaspoon (2mL) of saline solution will be placed into the
right upper lobe of the lung. A small amount of of cat dander or dust mite allergen solution
will be placed into the right middle lobe. The strength of the allergen squirted into this lobe
will be based on the results of the quantitative allergen skin testing that was done during Visit
1. We will first squirt a "test dose" of allergen that is much less than the full dose, into your
lung, which will be 1/2 teaspoon (2mL). We will pause and monitor your bronchial tubes,
making sure that this test dose does not cause severe tissue swelling or bronchial spasms
(narrowing of the bronchial tubes that can cause wheezing or chest tightness). If there is no
reaction to the test dose, we will then squirt the full dose of allergen into your right middle
lobe, which will be another 1/2 teaspoon (2mL).
The bronchoscope will be in place for approximately 30 minutes. During the bronchoscopy,
you will be able to signal the investigators to stop the procedure at any time by raising and
moving your hands away from yourself.
After the procedure you will recover in the ACRC Bronchoscopy Suite for at least 4 hours
and will have your vital signs monitored. We will check your lung function with spirometry
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after the bronchoscopy to make sure your lung function has returned to normal (within 15%
of your lung function measurements taken before the procedure). You will need to arrange to
have an adult escort you home after the bronchoscopy, as it is not safe to drive after the
sedation. You should plan to rest for the remainder of the day.
If you are an asthmatic participant, you will be given an albuterol rescue inhaler and ten
20mg pills of Prednisone to take home in case you experience an asthma attack following the
procedure. If that happens, we want you to call Prescott Woodruff, MD immediately for
further instructions at the numbers provided at the end of this Consent Form.
The study doctor will call you the evening of the bronchoscopy and a member of the study
staff will call you the next day, to make sure you have not had any side effects from the
bronchoscopy procedure. Prior to your next bronchoscopy visit, you will again be instructed
(i) not to eat or drink anything for 8 hours prior to your appointment, and (ii) make
arrangements with an adult to escort you home after the procedure.
Study visits
This study has three (3) visits.
1. Screening Visit: This visit is to determine if you are eligible to participate in the study.
2. First Bronchsocopy Visit with Allergen Challenge
3. Second Bronchoscopy Visit
Prior to each study visit you might be asked to withhold some of your medicines and instructions
will be given to you on the phone before your study visit. If you would prefer meeting with the
study doctor to discuss withholding medications beforehand, you may have an unscheduled
study visit.

Withholding your medicines before study visits:
Some medicines that you take can affect breathing tests or skin tests. For this reason, the
study doctors may ask you not to take some medicines for 24-48 hour period before
breathing tests. For example, if you use an albuterol (ProAir®, Ventolin®) inhaler, the
doctors may ask you not to use it in the 6 hours before you come to your visit.
Some allergy tablets can can have an effect on your skin prick test results, You may be
asked not to take them for up to 7 days. It is okay to restart the medicines at any time if your
breathing or allergies get worse. Please let the study team know which medicines you need to
restart since it may cause study visits to be rescheduled.
VISIT 1 – Screening Visit:
This visit will last approximately 6 hours.

Consent form: You will need to read and sign this form before doing any of the study
procedures. A copy will be given to you to keep.
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
Pregnancy testing: If you are a female of childbearing age, you will be asked to give a urine
sample so that we can perform a pregnancy test. Pregnant women cannot take part in this
study. This pregnancy test will be repeated at each subsequent visit.

Vital signs: Your blood pressure, heart rate, temperature and respiratory rate will be
checked. Your height and weight will also be measured.

Medical history: You will be asked about your general health and any illnesses you may
have or had in the past. You will be asked about medicines you are taking (including
prescriptions, over-the-counter medicine, vitamins or herbal treatments). You will provide
your medical record that is created here at UCSF, which contains laboratory test results
pertinent to this study. You will sign a separate medical records release form for this purpose.

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Physical examination: A physical examination similar to those for regular medical care.
Exhaled nitric oxide
Spirometry
Methacholine challenge test
Allergy prick skin test
Quantitative allergen prick skin test
Blood draw: Approximately 70 mL (5 tablespoons) of blood will be collected
Buccal swabs: Four swabs from the inside of your cheek will be collected

Medical questionnaires: You will complete questionnaires about your general health, your
respiratory health, and some general information about your socio-economic status.

Bronchoscopy review: You will be instructed (i) not to eat or drink anything for 8 hours
prior to your appointment, and (ii) make arrangements with an adult to escort you home after
the procedure.
If you cannot complete the screening visit in one day and would like to split Visit 1 across 2
days, this can be arranged with the study coordinator. These 2 visits (Visit 1-Day 1 and Visit 1Day 2) must be completed within 4 weeks of each other.
If you catch a cold or have any changes in your health from Visit 1 before your Visit 2
bronchoscopy, we may reschedule your Visit 2 procedure. A study doctor will review your
symptoms. If more than 12 weeks pass between your Visit 1 and Visit 2, you will need to repeat
Visit 1.
VISIT 2 – First Bronchsocopy Visit with Allergen Challenge:
(approximately 1-12 weeks after Screening Visit 1)
This visit will last approximately 7 hours. You will need an adult to drive you home.
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
Eating/drinking hold: You will not eat or drink anything for at least 8 hours prior to your
appointment.. If you are not able to do this, or if you forget and have something to eat or
drink, call the study coordinator at (415) 476-3824 or (415) 502-2892.

Medication withholding: You will not take aspirin or anti-inflammatory medications (like
ibuprofen) for at least 48 hours prior to your appointment. The study doctor may ask you to
not take other medication depending on your current medication list. If you are not able to
withhold your medications, call the study coordinator at (415) 476-3824 or (415) 502-2892.

Limited physical examination: A study doctor will listen to your chest and heart, and
review your medical history.

Medical update: You will be asked about any changes in your health and/or medications
since your last visit.

Vital signs/pulse oximetry/oxygen saturation:
Your blood pressure, heart rate,
temperature, and respiratory rate will be measured. The amount of oxygen in your blood will
be measured. Your weight will be recorded.

Urine collection: Up to approximately 50 mL (3-1/2 tablespoons) of urine will be collected.
Your urine will be used to study proteins that might be related to asthma, and it will be stored
for unspecified future research.

Pregnancy testing (females only)

Electrocardiogram: A number of sticky plastic tabs will be attached to your arms, legs and
chest, and a recording of the electrical activity of your heart is taken. This recording is
evaluated by the study doctor before the bronchoscopy.

Spirometry

Bronchodilator treatment: You will inhale 4 puffs of albuterol in preparation for the
bronchoscopy procedure. Spirometry will be performed after the albuterol treatment.
Additional bronchodilator treatments of albuterol or ipratropium bromide may be given to
relieve breathing symptoms (shortness of breath, chest tightness).

Blood draw: Approximately 70 mL (5 tablespoons) of blood will be collected

Bronchoscopy
o Bronchial washing
o Bronchial brushing
o Bronchial biopsy tissue samples

Segmental Allergen Challenge
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
Phone contact: The same evening as Visit 2, the study doctor will call you to check in and
see how you are feeling after the procedure. The study coordinator will perform the same
phone call 24 hours later. Each of these phone visits will take approximately 5 minutes.
VISIT 3 – Second Bronchoscopy Visit:
(You will be assigned to have the Visit 3 Bronchoscopy either 1 day or 7 days after Visit 2
Bronchoscopy)
This visit will take approximately 6 hours. You will need an adult to drive you home
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Eating/drinking hold: You will not eat or drink anything for at least 8 hours prior to your
appointment. If you are not able to do this, or if you forget and have something to eat or
drink, you will call the study coordinator at (415) 476-3824 or (415) 502-2892.
Medication withholding
Limited physical examination
Medical update
Vital signs/pulse oximetry/oxygen saturation
Urine collection: Up to approximately 50 mL (3-1/2 tablespoons) of urine will be collected
Pregnancy testing (females only)
Electrocardiogram
Spirometry
Bronchodilator treatment
Intravenous catheter
Blood draw: Approximately 70 mL (5 tablespoons) of blood will be collected
Bronchoscopy: This will be the similar to the bronchoscopy performed at Visit 2.
o Bronchial washing
o Bronchial brushing
o Bronchial biopsy tissue samples

Phone contact: The same evening as Visit 3, the study doctor will call you to check in and
see how you are feeling after the procedure. The study coordinator will perform the same
phone call 24 hours later. Each of these phone visits will take approximately 5 minutes.
How long will you be in the study?
We estimate that total study participation time may take up to 19 hours total over the course of 714 days.
Can you stop being in the study?
Yes. You can decide to stop at any time. Tell the study doctor if you are thinking about stopping
or decide to stop. He or she will tell you how to stop your participation safely.
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The study doctor may stop you from taking part in this study at any time if he/she believes
it is in your best interest, if you do not follow the study rules, or if the study is stopped.
What side effects or risks can you expect from being in the study?
You may have side effects while on the study. Everyone taking part in the study will be watched
carefully for any side effects. However, doctors don't know all the side effects that may happen.
Side effects may be mild or very serious. Your health care team may give you medicines to help
lessen side effects. In some cases, side effects can be serious, long lasting, or may never go
away. You should talk to your study doctor about any side effects you experience while taking
part in the study.
Likely

Eating/drinking holds: These may cause some anxiety and discomfort.

Spirometry: Breathing fast and hard into a spirometry breathing machine can be associated
with cough or lightheadedness.

Methacholine challenge test: Inhalation of methacholine may cause wheezing and cough,
sense of throat irritation, and shortness of breath. This is described by people as being similar
to a mild asthma attack. This will be temporary and may go away without treatment. If
symptoms are not tolerated you can be treated using inhaled albuterol.

Allergen skin prick testing: This is a common test for allergy. There may be itching and
burning at the site of the test. There may be discomfort from the prick from the plastic
applicator. This usually goes away within 30 to 60 minutes after the skin test. It may last for
24 to 48 hours.
Less Likely

Medication hold(s): Stopping some medications might involve some risk(s) or side effect(s)
to you. You should discuss any medication(s) change with your primary care provider and
the study physician.

Blood draw/intravenous catheter: There may be pain where the needle is insert. There is a
risk of bruising, swelling or rarely, infection. Some people experience dizziness, upset
stomach, or fainting when their blood is drawn.

Albuterol use: At least 3 out of 100 people taking albuterol reported headache, tachycardia
(increased heart rate), muscle pain, dizziness, pharyngitis (sore throat), and rhinitis (runny
nose). In less than 3 out of 100 people taking albuterol reported, chest pain, infection,
diarrhea, glossitis (soreness or swelling of the tongue), anxiety, dyspnea (difficulty
breathing), ear disorder, ear pain, and urinary tract infection were reported. In other studies
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where people have received multiple doses of Albuterol, the most common complaints
reported included shakiness, nervousness, and headaches.
Rare but Serious

Allergen skin prick testing: There is a very small risk of an infection at the site. Symptoms
such as itching all over the body, sneezing, and eyelid swelling occur in 1 per 10,000 people.
We will watch you for any such reaction and treat it if necessary. In rare cases, a severe
allergic reaction, that include hives and wheezing (also called anaphylactic reaction) can be
fatal.
Risks associated with the Bronchoscopy:
Likely

Fentanyl and midazolam for conscious sedation: If you require sedation with fentanyl and
midazolam, these medications may make you drowsy. You can not drive a car until the next
day after receiving the drug. You must make arrangements for an adult to escort you home.

Lidocaine: You will have some gagging during the spraying of your throat with lidocaine
but continued lidocaine treatments will suppress the gag response.

The bronchoscopy procedure may be uncomfortable but should not be painful. You may
experience brief coughing and gagging during the procedure. You will be able to signal the
study investigators to stop the procedure by raising your hand, and you will be able to contact
them if any problems arise afterwards. After the bronchoscopy procedure, you may
experience a dry mouth, cough, hoarseness, or sore throat.

Bronchial wash: There may be a minor discomfort and the urge to cough when the saline
solution is put into your lung. It may cause a coughing episode and a sense of fullness in your
chest. If you have a lot of coughing you may develop muscle soreness. You may notice a
slight increase in sputum/phlegm production for the next few days.

Bronchial brushing: This will not be painful but may cause cough or a little bleeding.

Bronchial biopsy: The removal of the tiny pieces of tissue lining your bronchial tube will
not be painful. There are no pain fibers in this area of the lung. You may feel a tugging
sensation as the tissues are removed. You may cough up small amounts of blood-tinged
sputum/phlegm after this procedure.
Less Likely
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
Bronchial wash: Occasionally, people can have a fever after the bronchial wash. The fever
may be associated with feelings of fatigue and some generalized muscle aches. These
symptoms do not necessarily mean that you have an infection. You may need to take Tylenol
to help relieve them. If fever, fatigue or muscle aches last more than 24 hours, you should
call the study team.
Rare but Serious

Fentanyl and midazolam for conscious sedation: If you require sedation with fentanyl and
midazolam, these medications will suppress your cough and induce relaxation. Some people
develop nausea or allergic reactions (hives, wheezing, flushing) from fentanyl. Midazolam
will decrease your feelings of anxiety and tension and may make it hard to remember the
bronchoscopy procedure. Some people develop drowsiness, fatigue, headaches, a loss of
coordination. In very rare instances, midazolam and fentanyl may cause a decrease in or stop
your breathing which would require us to place a breathing tube into your airways and
connect you to a machine that would help breathe for you. The placement of a breathing tube
has its own related risks including the risk of pneumonia or prolonged need for a breathing
tube. A nurse will be present and a physician will be available until the effects of fentanyl
and midazolam have worn off. Emergency equipment is available for treatment.

Lidocaine: This is the medicine used to suppress your gag response, and numb your throat
and bronchial tubes for the bronchoscopy procedure. Thousands of bronchoscopies have been
performed in research volunteers. A single death (April 1996) has been reported from a
research laboratory in another state, apparently from administration of an overdose of
lidocaine. If too much lidocaine is given to you, it can cause seizures or heart rhythm
problems. These side effects can be serious. You would need to be admitted to the hospital
for treatment. Because of this, the amount of lidocaine that is given to you will be carefully
monitored to ensure that you do not get too much. The ACRC Bronchoscopy Suite has
guidelines in place to limit the dose of lidocaine that can be given for research
bronchoscopies. A nurse will be present and a physician will be available until the effects of
lidocaine have worn off.

Segmental Allergen Challenge: There is a risk of a severe allergic reaction (anaphylaxis)
from the allergen challenge. The study doctor will be present and the study staff are prepared
to treat this type of reaction with emergency medications. There is also a chance of a delayed
allergic reaction that may occur a few hours after the procedure (including hives, coughing,
and sneezing). We will provide you with an albuterol inhaler and prednisone pills in case you
need them following the procedure. We will give you instructions about when you should
take these medications. If these symptoms occur, you are to call the study doctor.

Bronchial biopsy: Moderate or severe bleeding following biopsy collection occurs in less
than 1 in 100 patients with normal blood clotting function. There is approximately a 5 in 100
risk of a visible scar at the site of the airway tissue collection. Such scarring is not known to
lead to any health consequence in the experience of people who do these research
procedures.
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
Pneumothorax (collapsed lung): A pneumothorax can result from the breaking of lung
tissue allowing air to enter the space surrounding the lung (pleural space) causing partial
collapse of the lung. This complication, though potentially serious, occurs rarely (about 1 in
200 patients) when experienced personnel perform the bronchoscopic procedure. Treatment
will be available if necessary.

Spasm of your vocal cords: This can occur when the bronchoscope is passed through your
vocal cords. This is rare. If it happens the bronchoscope will be removed. You will be treated
with albuterol and given supplemental oxygen.

Infection of your lungs: Bronchitis or pneumonia can occur in the first days or even week
after bronchoscopy. If this occurs you would notice it as fever and you would have green
phlegm. If it happened you might require treatment with antibiotics.

Shortness of breath and wheezing: The bronchoscopy procedure may cause your lung
disease (if you have any) to be worse in the days immediately after the procedure. If this
occurs you should notify the researchers. You may need to increase the number of times you
use your medications or have to take steroid tablets (prednisone). Risks of a short course of
prednisone include an increase in appetite, hyperglycemia, difficulty sleeping, mood change,
headache, changes in blood pressure and an increased risk for oral candidiasis (“thrush”).
Unknown Risks: In addition, there may be uncommon or previously unknown risks that might
occur. You should report any problems to the researchers. The researchers will let you know if
they learn anything that might make you change your mind about participating in the study.
Emergency care / Hospitalization: If you seek emergency care, or are admitted to the hospital,
please tell the doctor that you are participating in a medical research study, and have them
contact the study doctor, Prescott Woodruff, MD, at (415) 514-2061, pager (415) 443-7640.
Are there benefits to taking part in the study?
There will be no direct benefit to you from participating in this study. Information learned from
this study may someday benefit future people with asthma.
What other choices do you have if you do not take part in this study?
You may choose not to be in this research study. There will be no effect on your medical care.
Pregnancies, breastfeeding and birth control:
You cannot participate in this study if you are currently pregnant or breastfeeding.
Treatments and procedures involved in this research project may involve unexpected risks to
your unborn or nursing child. If you are female of childbearing potential, a pregnancy test will be
performed prior to your enrollment and at each visit during this study.
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If you should become pregnant while participating in this study, or if you suspect that you have
become pregnant, contact Dr. Prescott Woodruff.
How will information about me be kept confidential?
Participation in research involves some loss of privacy. We will do our best to make sure that
information about you is kept confidential, but we cannot guarantee total privacy. Some
information from your medical records will be collected and used for this study. If you do not
have a UCSF medical record, one will be created for you. Your signed consent form and some
of your research tests will be added to your UCSF medical record. Therefore, people involved
with your future care and insurance may become aware of your participation and of any
information added to your medical record as a result of your participation. Study tests that are
performed by research labs, and information gathered directly from you by the researchers will
be part of your research records but will not be added to your medical record. Your personal
information may be given out if required by law. If information from this study is published or
presented at scientific meetings, your name and other personal information will not be used.
Organizations that may look at and/or copy your medical records for research, quality assurance,
and data analysis include:
 The University of California
 The study sponsor, the National Institute of Allergy and Infectious Diseases (NIAID)
 Other government agencies, e.g., the Food and Drug Administration (FDA), involved in
keeping research safe for people.
To help us protect your privacy, we will obtain a Certificate of Confidentiality from the National
Institutes of Health. 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.
Exceptions: A Certificate of Confidentiality does not prevent researchers from voluntarily
disclosing information about you without your consent. For example, we will voluntarily
disclose information about incidents such as child abuse or intent to hurt yourself or others. In
addition, the Certificate 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. Finally, the Certificate may
not be used to withhold information from the federal government needed for auditing or
evaluating federally funded projects or information needed by the FDA.
What are the costs of taking part in this study?
If you enroll in this study, you will have some tests and procedures that are only part of the
research study. All tests and procedures related to the study will be paid for by the study. If we
find anything that is not normal, you may need additional testing. In the event additional testing
is required, the study will not pay for these tests or procedures. If you would like, we can give
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you copies of any applicable test results that have a clinical meaning for you to take back to your
physician (e.g. complete blood count with differential results).
Will you receive anything for being in this study?
In return for your time, effort and travel expenses, you will be reimbursed at UCSF’s “standard
rate” of $35.00 for the first hour. You will recieve $25.00 per hour for the additional time for
Visit 1. For the bronchoscopy Visits 2 and 3, you will be reimbursed $400 for completing the
bronchoscopy procedure and will receive an additional reimbursement $25 per hour for any time
spent in the Airway Clinical Research Center in excess of 4 hours. Your parking will be
validated. If you complete all visits, you will be reimbursed approximately $1,085.
If you are ineligible to participate in the study, you will be reimbursed for those visits completed
only. If you terminate early from the study, you will be reimbursed for those visits or portions of
visits you completed. If you repeat the screening visit (Visit 1), you will be reimbursed for both
screening visits at the standard rate.
You must supply your name, address, and social security number so that the accounting office
can issue you a check. It usually takes 3 to 6 weeks to receive a check, which will be mailed to
your address. The University of California, San Francisco is required to report payments of $600
in total over the course of one year or more to the IRS. You will need to pay taxes on the money
you receive.
What will happen if you are injured by this research?
It is important that you tell your study doctor, Dr. Prescott Woodruff, if you feel that you have
been injured because of taking part in this study. You can tell the doctor in person, call him at
(415) 514-2061, or page him at (415) 443-7640. You can also contact our 24-hour advice line at
415-758-2272 to speak to or leave a message for any of our study physicians.
Treatment and compensation for injury: If you are injured as a result of being in this study,
the University of California will provide necessary medical treatment. The costs of the treatment
may be billed to you or your insurer just like any other medical costs, or covered by the
University of California, depending on a number of factors. The University does not normally
provide any other form of compensation for injury. For further information about this, you may
call the office of the Committee on Human Research at 415- 476-1814.
The sponsor of the research, the National Institutes of Health Division of Allergy, Immunology
and Transplantation, has no program for monetary compensation or other forms of compensation
for research related injuries.
What are your rights if you take part in this study?
Taking part in this study is your choice. You may choose either to take part or not take part in the
study. If you decide to take part in this study, you may leave the study at any time. No matter
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what decisions you make, there will be no penalty to you and you will not lose any of your
regular benefits. Leaving the study will not affect your medical care. You can still get your
medical care from our institution.
We will tell you about new information or changes in the study that may affect your health or
your willingness to continue in the study.
In the case of injury resulting from this study, you do not lose any of your legal rights to seek
payment by signing this form.
Who can answer my questions about the study?
You can talk to your study doctor about any questions, concerns, or complaints you have about
this study. Contact the study doctor, Dr. Prescott Woodruff, at (415) 514-2061, pager (415) 4437640, or the study coordinators, Christine Nguyen at (415) 476-3824 or Bobby Antalek at (415)
502-2892. If you are unable to reach these individuals, or if you have an immediate need to
speak to a physician regarding this research study, you may page the physician on-call for this
study at (415) 758-2272 (24 hours/day).
If you wish to ask questions about the study or your rights as a research participant to someone
other than the researchers or if you wish to voice any problems or concerns you may have about
the study, please call the Office of the Committee on Human Research at 415-476-1814.
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 can search this Web site at any time.
If you choose to participate in this study, we will also ask permission from you in a separate
consent form to store the samples that we collect from you in a “Tissue Bank” which may used
for future research studies. In order to participate in this study, you must agree to also participate
in the Tissue Bank. Additional detail on the Tissue Bank will be reviewed with you in the
separate “Tissue Bank Consent Form”.
Information collected from your participation in this study will be entered into a UCSF Airway
Clinical Research Center (ACRC) recruitment database so that you may be contacted about
future research studies.
If you wish to allow your information to be entered in the UCSF ACRC recruitment
database, please answer the following by writing your initials by “Yes” or “No” below:
I agree to let UCSF Airway Clinical Research Center enter my information into a
recruitment database for future studies.
Yes
ACE Study Consent
No
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******************************************************************************
CONSENT
You have been given copies of this dated and signed consent form and the Experimental
Subject's Bill of Rights to keep.
You will be asked to sign a separate form authorizing access, use, creation, or disclosure of
health information about you.
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to
participate or to withdraw at any point in this study without penalty or loss of benefits to which
you are otherwise entitled.
If you wish to participate in this study, you should sign below.
_________________________________________________
Signature of Research Participant
__________________
Date
_________________________________________________
Printed Name of Research Participant
_________________________________________________
Signature of Research Team Member Obtaining Consent
__________________
Date
_________________________________________________
Printed Name of Research Team Member Obtaining Consent
ACE Study Consent
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