UNIVERSITY OF CALIFORNIA, SAN DIEGO CONSENT TO ACT AS A RESEARCH SUBJECT

Transcription

1 15 pages UNIVERSITY OF CALIFORNIA, SAN DIEGO CONSENT TO ACT AS A RESEARCH SUBJECT ADULT CONSENT Protocol Title: (CPAP)-Effect of Positive Airway Pressure on Reducing Airway Reactivity in Patients with Asthma Principal Investigator: Xavier Soler, MD IRB number: Protocol: Version 1.6 April 13, 2012 Sponsor: This study is sponsored by the American Lung Association (ALA) and the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH). What you should know about this study UCSD is an American Lung Association affiliated center where 20 subjects will participate in this study. You are being asked to join a research study. This consent form explains the research study and your part in the study. Please read it carefully and take as much time as you need. You are a volunteer. You can choose not to take part and if you join, you may quit at any time. There will be no penalty if you decide to quit the study. During the study, we will tell you if we learn any new information that might affect whether you wish to continue to be in the study. Children and adults can join this study. If your child is joining, the word you in this consent form will refer to both you and your child. Please ask questions at any time about anything you do not understand During the study, you will not have access to certain medical information and test results collected for study purposes. If an emergency occurs while you are in the study, medical information needed for your treatment can be made available to your study physician and other physicians who treat you. When the study is completed, all the information in your medical record will be available to you. Participation in this study is not meant to replace usual care for your asthma. You should tell your regular asthma doctor that you are in this research study and, in addition, we will send a letter to tell him or her that you are in this study. We will contact your doctor if you cannot be in this study because you have poor asthma Page 1 of 15

2 control. We will also contact your doctor during the study if you have poor asthma control and need additional medical care. This study is sponsored by the American Lung Association (ALA) and the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH). Drs. Soler, Ramsdell and Wasserman are being paid to conduct this study. Purpose of research project This research is being done to find out if using CPAP (continuous positive airway pressure) during sleep makes the breathing passages ( airways ) less reactive in people with asthma. The airways of people with asthma may be sensitive to different things in the air and react by narrowing. This narrowing is called airways reactivity. CPAP is a flow of air through a mask worn over the nose or face. The mask is connected to a machine that delivers air pressure while you breathe. CPAP is used to treat sleep problems like Obstructive Sleep Apnea but has not been used to treat asthma. We want to do this study because other research suggests that using CPAP to stretch the airways during sleep may make airways less reactive. In this study we will ask participants to use CPAP. We will do a breathing test called the methacholine challenge test. Methacholine is a drug that can cause the airways to narrow. The test measures how much, if any, the airways narrow after breathing in mists that contain different concentrations of methacholine. We also want to know if it matters how much air pressure is used and if using CPAP improves asthma and control symptoms. People in the study will get one of three different pressure settings of CPAP to use every night at home: CPAP with pressure of less than 1 cm H 2 0 (low pressure) CPAP with pressure of 5 cm H 2 0 (medium pressure) CPAP with pressure of 10 cm H 2 0 (high pressure) CPAP with pressure of less than 1 cm H 2 0 (no pressure) (cm H 2 0 is a measure of pressure.) In addition getting one of these levels of air pressure, you will breathe filtered, warmed and humidified air when using your CPAP device. The CPAP device that is used in this study is approved by the U.S. Food and Drug Administration (FDA) for use in sleep disorders. It is not approved for treatment of asthma. Why you are being asked to participate You are being asked to participate in this study because you have asthma, which is characterized as having very sensitive airways. People who have been diagnosed with asthma by a doctor and have stable asthma and reactive airways may be eligible to join this study. Males and females 15 Page 2 of 15

3 to 60 years old may join. Women who are pregnant or breastfeeding cannot join the study. To be eligible for the study women who are capable of having children must agree to practice an adequate method of birth control (abstinence, combination barrier and spermicide or hormonal) for the duration of the study. If you want to join the study, you will need to complete a screening visit (Visit 1) to see if you meet all the eligibility requirements. You must meet all the requirements to continue in the study and get study CPAP study groups. If you are unable to complete the screening tests or the results show that you do not qualify, you will not get CPAP and will not be able to continue in the study. We plan to enroll about 192 people in the study in a network of 18 clinical centers across the United States. Johns Hopkins is the coordinating center for the study and will not enroll any people. Procedures The study will last for 16 weeks. You will have 6 clinic visits and one phone visit. You will be asked to use CPAP every night while you are sleeping for 12 weeks beginning at Visit 2. The schedule of visits is shown below. Visit number Visit type Time after previous visit Length of visit Visit 1 Screening hours Visit 2 Random Assignment 0 to 2 weeks after Visit 1 3 hours Visit 3 Telephone contact 1-3 days after Visit 2 15 minutes Visit 4 Follow-up 1 week after Visit 2 2 hours Visit 5 Follow-up 5 weeks after Visit hours Visit 6 Follow-up 6 weeks after Visit hours Visit 7 Follow-up 2 weeks after Visit hours A summary of what will happen at each study visit is provided below. The specific study procedures are described later in this section. Study visits Visit 1 is a screening visit to see if you are eligible for the study. The visit will last about 4 hours. We will explain the study, answer your questions and ask you to sign this consent. You will answer questions about your medical and asthma history, complete questionnaires, have a methacholine test and, if applicable, a pregnancy test. The methacholine test may need to be completed at a different day than the rest of Visit 1. This is because the methacholine challenge Page 3 of 15

4 test cannot be done if you have taken asthma medicines within a certain number of hours before the test. Visit 2 will be done from 0 to 14 days after Visit 1 and will last about 3 hours. We will finalize your eligibility. If you are eligible, we will randomly (like flipping a coin) assign you to one of three pressure levels of study CPAP. You will have an equal chance of receiving one of the three study groups. We will give you a study CPAP machine and mask to use while you are in the study. You also will answer questions about your health and asthma, complete questionnaires, have blood drawn, have a brief physical exam and have your exhaled nitric oxide measured. Visit 3 is a phone call one to three days after the last visit to find out how you are doing with using CPAP. The call will last about 15 minutes. If your CPAP mask is not fitting well, we may ask you to come to the clinic to get a new mask fitted. Visit 4 is a follow-up visit one week after you start using CPAP and will last about 2 hours. We will ask you questions about your health and asthma and get information from your CPAP machine about your CPAP use (when and how long you used CPAP). Visit 5 is a follow-up visit about 5 weeks after the previous visit and will last 3-4 hours. You will answer questions about your health and asthma, complete questionnaires, have a methacholine test and, if applicable, a pregnancy test. We will review your use of CPAP. Visit 6 is a follow-up visit about 6 weeks after the previous visit and will last 3-4 hours. You will return the CPAP machine. You will answer questions about your health and asthma, complete questionnaires, have blood drawn, have your exhaled nitric oxide measured, have a methacholine test and, if applicable, a pregnancy test. We will review your use of CPAP. Visit 7 is the final study visit. It will be about 2 weeks after the previous visit and will last 3-4 hours. You will answer questions about your health and asthma, complete questionnaires, have blood drawn, have your exhaled nitric oxide measured, have a methacholine test and, if applicable, a pregnancy test. We will conduct an exit interview and give you an envelope with a card inside that will tell you which of the three pressures of CPAP you used during the study. Study procedures CPAP: CPAP is a small amount of air pressure applied through a mask worn over your nose while you are sleeping. If you qualify for the study we will ask you to use CPAP every night while you are sleeping for 12 weeks. You will be given a study CPAP machine to use while you are in the study. To use CPAP you wear a mask over your nose held in place by straps around your head. The mask is connected to the CPAP machine by a tube. Air will flow from the CPAP machine through the tube and into your nose. There are three setups for CPAP in this study: 10 Page 4 of 15

5 units of pressure (high), 5 units of pressure (medium), or less than one unit of pressure (low). About a third of participants will get CPAP with a pressure setting of 5 cmh 2 0, a third to10 cmh 2 0 and a third to pressure of less than 1 cmh 2 0 (no pressure). You will not know which CPAP pressure level you are getting while you are in the study, but this information can be obtained if medically necessary. At every study visit we will ask you to tell us about any side effects or problems you have using CPAP. You will need to bring your CPAP machine and mask to study visits. The CPAP machine stores information that will tell us when and how long you used it. We will look at this information and talk to you about it. The CPAP part of the study ends at visit 6 and we will keep the CPAP machine at that visit. Peak Expiratory Flow: This is a measure of your ability to breathe out air. You will measure and record your peak flow every morning while you are in the study. We will give you a peak flow meter. To use it, you need to take a deep breath and make a strong blow into the tube. At Visit 1 we will show you how to use the peak flow meter and how to read and record the results. If you cannot use the peak flow meter, you cannot join the study. You can keep the peak flow meter after the study is over. Spirometry: This test will be done as part of the methacholine tests at visits 1, 5, 6, and 7. Spirometry is a test that measures how well you are able to breathe. This test measures the amount of air you have in your lungs and how hard you can blow it out through your mouth into a tube. You will be weighed and your height will be measured before this test. You will wear a nose clip and breathe out forcefully into a machine that measures how much air you blow out and how fast it comes out. Methacholine challenge test: You will have a methacholine challenge test at visits 1, 5, 6 and 7. This test measures how much, if any, the airways narrow when you breathe in methacholine. This is called airway responsiveness. For safety reasons, we will not do the methacholine test if you are having asthma symptoms or if your lung function is less than 70% of normal before starting the test. Each methacholine challenge test may take 30 to 60 minutes. The test begins with spirometry followed by repeated tests after breathing in up to 11 mists of different solutions. After each mist is breathed in, your lung function will be measured. Each lung function test takes 2 to 5 minutes. The first mist used in the test contains no methacholine, only saline (salt water) and a preservative (phenol) that helps to keep the solution sterile. The second mist contains a very small dose of methacholine, and each solution that follows contains a larger dose of methacholine in the mist. Each of these mists also contains saline and preservative. After taking 5 breaths of the first mist, you will do another breathing test (spirometry) to see if there has been any effect. Once your ability to blow out forcefully decreases by 20% or other symptoms develop the test is finished. If your lung function does not change much you will Page 5 of 15

6 breathe in the next mist, and the breathing test (spirometry) will be repeated. This process will continue until you have a significant change in lung function or after the eleventh mist is given. The test may be stopped earlier, before lung functions drops by 20%, if you develop asthma symptoms or other bad effects. When the test is finished, if your lung function dropped by 20% or more, you will be given a bronchodilator (albuterol) to open the airways. Breathing is measured after the bronchodilator is used, to be sure that all effects of the methacholine are over. You will not be allowed to leave the clinic until breathing has returned to normal or nearly normal level. Exhaled Nitric Oxide: At visits 2, 6 and 7 we will ask you to take a deep breath in and then blow out all the air slowly into a machine that records the amount of nitric oxide you blow out. Nitric oxide is a measure of inflammation in your lungs. Pregnancy test: Woman who are capable of having children will have a pregnancy test at Visits 1, 5, 6, and 7. The pregnancy test will require a sample of blood or urine. If you are under the age of 18, we will notify your parents if you have a positive pregnancy test. If you do not want this to happen you should not participate in this study. Questionnaires: You will be asked to complete questionnaires at Visits 1, 2, 5, 6 and 7. Most questionnaires consist of a series of multiple choice questions. You will be asked to complete: - two questionnaires about your sleep symptoms at Visit 1 - two questionnaires about your sleep habits, the quality and how sleepy you are during the day at visits 1, 5, 6 - three questionnaires about your asthma symptoms and daily activities and one questionnaire about sinus and nasal symptoms at Visits 2, 5, 6 and 7 Asthma diary: You will be asked to complete a paper asthma diary and an online asthma diary every day starting after Visit 1 and continuing for the 16 weeks you are in the study. You will record your peak flow, your asthma symptoms or other symptoms you might experience, your use of CPAP and asthma medications. You should bring the completed asthma diary cards when you come for each visit. Blood draw: You will have blood taken from a vein in your arm at Visits 2, 6 and 7 to test for markers of inflammation. Some of the blood will be saved for possible future tests related to inflammation and asthma. At visit 2 we will draw no more than 2 tablespoons of blood. At visits 6 and 7 we will draw no more than 4 teaspoons of blood per visit. In total about 70 ml (about 5 tablespoons) of blood will be collected during the study. If you agree, some of the blood drawn at visit 2 may be saved for DNA/genetic testing. Possible future DNA/genetic testing includes tests on the genes (material that contains information about our ancestors) that may play a role in determining whether someone gets asthma, how severe the Page 6 of 15

7 asthma may be, and the response to asthma treatments. Donating your blood for DNA/genetic testing is optional and not required for participation in the study. The Genetic Information Nondiscrimination Act (GINA) may help protect you from health insurance or employment discrimination based on genetic information. This law provides that health insurance companies and group health plans - may not ask for genetic information from this research and - may not use genetic information when making decision about eligibility or premiums The law will not stop health insurance companies from using genetic information to decide whether to pay claims. The law also will not help you get other types of insurance (such as: life, disability or long-term care). The blood samples obtained in this study for DNA tests will be analyzed exclusively for genes of diseases related to asthma and allergy. Your DNA samples will not be sold. Please indicate below whether you wish to have your blood drawn for DNA genetic testing pertaining to asthma and allergy: Please initial your choice below: I agree to donate my DNA for use in this study and to be stored for possible future genetic analysis. I do not agree to donate my DNA for use in this study or to be stored for possible future genetic analysis. Because of confidential coding of specimens, you will not be notified of individual results from DNA tests and no results will appear in your study records or medical records. Once you donate DNA, we will strip personal identifiers from the sample, and it will not be possible to retrieve the sample later. Risks/discomforts General risks: Your asthma may not improve or may worsen while participating in this study. Uncontrolled asthma may be life-threatening. Increased use of your rescue medications is a sign that your asthma may be getting worse. If you feel that your asthma is getting worse, use your rescue medicine. Then call your regular doctor immediately. Get emergency medical care if: your breathing problems worsen quickly and if you use your rescue inhaler medicine, but it does not relieve your breathing problems. Page 7 of 15

8 Risks of CPAP: There is little experience with CPAP use in asthma but it is generally safe for people with sleep apnea. The most common side effect of CPAP is that the mask fit is uncomfortable and takes some time to get used to. If your mask is not fitting well or if you find CPAP uncomfortable, it may interfere with your sleep. If you think that your mask is not fitting properly, you should contact us and we can fit you for another type or size of mask. Some people have had nosebleeds, dryness, or stuffiness of the nose, mouth or throat with CPAP. The study CPAP devices have a filter and a humidifier that may prevent or lessen the feeling of dryness. Some people have reported a feeling of ear fullness or sinus discomfort. These symptoms may require a nasal decongestant or nasal saline spray. Please read the warning on the nasal spray bottle, you should not use any decongestant more than 5 days unless you are advised by your doctor. Skin irritations or rashes also have been reported as side effects. It is also possible that you can swallow air into your stomach which will cause a sensation of bloating or gas. This can usually be treated with elevation of the head of the bed or sleeping propped up on pillows. There is no evidence that CPAP makes asthma worse. We expect that some participants will benefit from breathing warm, moist filtered air while they sleep. However, it is possible that using CPAP may cause your asthma to get worse. If you have difficulty breathing while using CPAP, you should take the mask off right away and contact the clinic as soon as possible. If your asthma seems to be getting worse, you should also contact the clinic right away. Risks of Spirometry: There is little risk from spirometry. Some people may have chest soreness or light-headedness from the hard blowing. The chest soreness usually goes away by itself, but can be relieved with non-prescription pain-relievers. Risks of Methacholine Challenge: Methacholine challenge should not be done in anyone with current asthma symptoms (such as, asthma causing shortness of breath or chest discomfort or wheezing on the day of the test) or low lung function. The methacholine challenge will not be done unless you meet lung function requirements; a breathing test is done before the challenge starts to measure and check your lung function on the day of the test. Methacholine challenge should not be done in anyone with known allergy to methacholine. There may be other reasons you cannot take this test. There are other medical conditions that are affected by methacholine. If you have such a condition, your study doctor must approve of you taking the test. This test is not likely to cause serious symptoms. Some people have coughing or a tight sensation in their chest from breathing the methacholine, but it is usually mild. About 1 in 4 subjects having this test notices some cough or shortness of breath and about 1 in 10 notices some wheezing. However, reaction to methacholine can include severe bronchoconstriction (such as, a severe asthma attack). There will be 4 methacholine challenge tests over a 16 week period. This more testing than is usually done for asthma care. However, other research studies have shown that multiple tests can be given to patients with asthma safely. Page 8 of 15

9 Risks of Albuterol: Albuterol may be given after the methacholine test to dilate the breathing passages. On rare occasions (less than 5% of the time) it may cause nervousness, a rapid heartbeat or headache at the doses used in this study. If you develop any of these problems, we will monitor you closely until the problem goes away (typically in 30 minutes). On rare occasions, albuterol may cause arrhythmias (the heart beats in an abnormal way) or low potassium. These side-effects are usually related to taking high doses of the medication and so are very unlikely to occur during this study. Risks of peak flow measurement with peak flow meter: Asthma patients commonly use peak flow meter readings to see how their lungs are doing. There is little risk from use of a peak flow meter. Some people may have chest soreness from the hard blowing or light-headedness if they use it standing up. The chest soreness usually goes away by itself, but can be relieved with nonprescription pain-relievers. If you get lightheaded, you should perform the peak flow measurements while sitting down. Risks of exhaled nitric oxide measurement: Measurement of nitric oxide in your breath is a simple procedure with little or no risk. It is possible to feel lightheaded if you blow too hard. Risks of blood draws: Taking blood may cause discomfort, bleeding or bruising where the needle enters the body. In rare cases, it may result in fainting. There is a small risk of infection. Risks of DNA testing: Donating blood for DNA testing is optional. If you agree to allow your blood to be used for DNA testing, every effort will be made to keep the results of the DNA testing on your sample confidential. However, there is a very small risk that an unauthorized person may review your information. Therefore, there is a very slight risk that a test result could be linked to your identity and disclosed to you or to a third party. If you were to find out the result of a genetic test that indicated a problem, it could cause anxiety or other psychological distress. In addition, you might have to decide whether or not to discuss the findings with members of your family. If a third party (like your employer or insurer) learned the results, there is a risk of discrimination that could affect your employability or insurability, of stigma, and of the unpredicted disclosure of this information to others. Presently we know of no risk to you if the genetic results become known. Dr. Soler will be responsible for deciding how your DNA will be used. The specimens collected from you and the DNA that they contain may also be used in additional research to be conducted by the University of California personnel collaborating in this research study. These specimens, DNA, and their derivatives may have significant therapeutic or commercial value. You may consent to such uses. Risks of completing questionnaires: You may get tired or bored when we are asking you questions or you are completing questionnaires. You do not have to answer any question you do not want to answer. Page 9 of 15

10 Risk of Online diary: The Wellaho system secures all the personal information (EPHI/PII) immediately on entry so that only you and study staff will have access to it. For example, when the you first register, your name and contact details are encrypted so that only you and the study staff can retrieve that data. Nobody else, including Wellaho administrators, can read that data since it is encrypted using the your password. Other information, like your measured peak flow value, is not encrypted but is de-identified so that nobody other than yourself and the study staff can associate it with you. After the conclusion of the study, your identifiable information will be destroyed. De-identified information will be retained indefinitely for analysis. Risks related to pregnancy: Safety of the study during pregnancy or nursing is unknown. The safety of methacholine during pregnancy and nursing is not known. Women who are pregnant or nursing may not join the study. Women who are capable of becoming pregnant must agree to practice adequate birth control (no sexual intercourse, combination barrier and spermicide, or hormonal) for the length of the study. Women who are capable of becoming pregnant will have a pregnancy test at the screening visit and before each methacholine test. If you suspect you have become pregnant during the study, you must agree to contact the study doctor immediately and notify him/her of your condition and of any problems you have while you are pregnant. There may be other side effects and discomforts that are not yet known. Benefits There may or may not be direct benefits to you from participation in this study. It is unknown whether the CPAP study group will improve your asthma. You will receive tests of your asthma and asthma control, but this is not a substitute for regular asthma care by your usual asthma care provider. You will receive assessment of your general health and your asthma. You will be given a peak flow meter to monitor your asthma. At the end of the study you can keep this so that you can monitor your asthma. If you take part in this study, you may help others in the future. You may have some emotional benefit to know that your participation may help other people with asthma in the future. Payment If you are eligible and agree to join this study, you will be paid for completing each in person study visit. The money is given to reimburse you for your time and to pay for expenses such as transportation to study visits. The payments for each visit are: $50 for Visit 1 $50 for the first methacholine challenge test $50 the Visit 2 $100 each for Visits 4, 5, and 7 $150 for Visit 6 Page 10 of 15

11 There is no payment for Visit 3. Visit 3 is a short telephone call. To receive payments for the final two visits, you must return the CPAP device to the clinic. Thus, you will receive up to $600 for taking part in this study and using the study CPAP machine. If you leave the study before finishing all visits, you will only be paid for the parts you have completed. Protecting data confidentiality All research projects carry some risk that information about you may become known to people outside of the study. Johns Hopkins has rules to protect information about you. Federal and state laws also protect your privacy. This part of the consent form tells you what information about you may be collected in this study and who might see or use it. We will ensure your privacy by conducting study visits in a private place. We will keep your records in a secure place. Only clinical center staff or people authorized to audit the study will have access to the study forms. The people working on the study at this clinic will collect information about you. This includes things learned from the procedures described in this consent form and other information including your name, address, date of birth, and other details. Your name and other identifying information will be kept private. Generally, only people on the research team will know that you are in the research study and will see your information. A unique number and special code will be used in place of your name on samples and for data entry. The number and code cannot be linked to your name except at the clinical center where you complete visits. Data collected from your study visits will be labeled with only the unique number and special code. Study data will be sent to the Data Coordinating Center at The Johns Hopkins University in Baltimore, Maryland. Sometimes other people who are not part of the research team may see or give out your information. These people may see your identifying information when monitoring the study progress and checking that the study is being done properly: UCSD Human Research Protections Program (also known as IRB) and their staff Legal counsel, audit and compliance staff, officers of the organization and other people who need to see the information to help this study or make sure it is being done as it should. Study sponsors and people that the sponsors may contract with for this study. The sponsors for this study are the American Lung Association (ALA) and the National Heart, Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH). Page 11 of 15

12 Federal regulatory agencies: Your information may be disclosed to NIH or other regulatory agencies such as the Food and Drug Administration (FDA) for auditing purposes and is subject to subpoena. Members of the Data Safety Monitoring Board Central reading centers and central processing laboratories If data are in a form that identifies you, Johns Hopkins may use them for future research only with your consent or IRB approval. We cannot do this study without your permission to use and give out your information. You do not have to give us this permission. If you do not, then you may not join this study. We will use and disclose your information only as described in this form and in our Notice of Privacy Practices. We try to make sure that everyone who needs to see your information keeps it confidential but we cannot guarantee this. The use and disclosure of your information has no time limit. You can cancel your permission to use and disclose your information at any time by contacting the Principal Investigator of this study. The Principal Investigator can be reached by phone at (619) or by sending a letter to: Xavier Soler, M.D 210 Dickinson St. CTF-A, Room 102 San Diego, CA You also may choose the option of contacting the UCSD Human Research Protections Program. The UCSD Human Research Protections Program can be reached by phone at or by sending a letter to: University of California, San Diego Human Research Protections Program 9500 Gilman Drive, Mail Code 0052 La Jolla, CA Fax: If you send a letter, please be sure to include the study number and protocol number and your contact information. If you do cancel your permission to use and disclose your information, your part in this study will end and no further information about you will be collected. Your cancellation would not affect information already collected in this study. Page 12 of 15

13 Alternatives to participation You do not have to join this study. If you do not join this study your care at UCSD Clinical Trials Center will not be affected. Biological specimens The blood sample and data collected from you during this study are important to science. You will not own the blood sample or data after you give it to the study. You will not receive any financial benefit from any product or idea created by the investigators using the data or materials collected from you. Should you decide to donate your DNA for genetic testing, your DNA samples will remain in the possession of the American Lung Association and stored at the Pharmacogenetics Center, Nemours Children s Clinic, Jacksonville, FL. The results of this genetic research might be valuable for commercial and/or intellectual property (for example, patent) purposes. If you decide to participate in this genetic research, you are giving your sample to the American Lung Association. The American Lung Association retains sole ownership of the research results, and of any use or development of the research records (including your sample) consistent with this consent. Cost of participation in the study There are no costs to you for any of the study visits, procedures, or use of the CPAP machine while you are in the study. What happens if you leave the study early? You can agree to be in the study now and change your mind later. If you wish to stop, please tell us right away. We ask you to return the CPAP device and mask to us Leaving this study early will not stop you from getting regular medical care at UCSD Clinical Trials Center. If you leave the study early, Johns Hopkins may use or give out your health information that it already has if the information is needed for this study or any follow-up activities. The study doctor or the sponsor may stop your participation in this study at any time without your consent. This may happen if: Staying in the study would be harmful to you. You need treatment not allowed in the study. You fail to follow instructions. You become pregnant. The study is cancelled. There may be other reasons to take you out of the study that we do not know at this time. Page 13 of 15

14 Sharing your health information with others If we believe your asthma is not well controlled we may contact your asthma doctor and possibly share results of the asthma tests you have in the study. As a part of this study, the researchers may ask to see your health care records from your other health care providers. We may ask your other health care providers to give us information about your health care involving your asthma or any adverse event that happened to you while you were in the study. Payment of treatment costs for injury or illness from study participation If you are injured as a direct result of participation in this research, the University of California will provide any medical care you need to treat those injuries. The University will not provide any other form of compensation to you if you are injured. You may call the Human Research Protections Program Office at (858) for more information about this, to inquire about your rights as a research subject or to report research-related problems. Neither ALA, NIH, federal government and the John Hopkins Medical Institutions will provide any other form of compensation if you are injured. Dr. Xavier Soler, Joe Ramsdell or Stephen Wasserman and/or Tonya Green/Sam Ung has explained this study to you and answered your questions. If you have other questions or research-related problems, you may reach Dr. Soler or the study team at (619) or toll free at (888) Clinical Trial Registration A description of this clinical trial will be available on as required by US. 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. Who do I call if I have questions or problems? Call the principal investigator, Dr. Xaver Soler at (619) if you have questions, complaints, or get sick or injured as a result of being in this study. Call or contact the UCSD Human Research Protections Program (IRB) Office if you have questions about your rights as a study participant. Contact the IRB if you feel you have not been treated fairly or if you have other concerns. The IRB contact information is: Address: UCSD Human Research Protection Program 9500 Gilman Drive, Mail Code 0052 La Jolla, CA Telephone: Fax: Page 14 of 15

15 What does your signature on this consent form mean? Your signature on this form means: You have been informed about this study s purpose, procedures, possible benefits and risks. You have been given the chance to ask questions before you sign. You have voluntarily agreed to be in this study. Print name of Adult Participant Signature of Adult Participant Date Print name of Person Obtaining Signature of Person Obtaining Consent Date Consent Give one copy to the participant and keep one copy in study records Page 15 of 15