Research Subject Information and Consent Form Main Consent ...

Sputum Induction: You may experience a salty after taste in the mouth, coughing, afeeling of needing to swallow, a sore throat, shortness of breath, wheezing, chesttightness, lightheadedness, nausea or headache. In rare cases, some patients have hada severe asthma attack or a reaction to the salty water that they breathe in.Bronchodilator treatment will be available if this occurs.Blood draw: You may experience some pain or bruising where the needle enters theskin. You may also feel faint or sick to your stomach while having your blood drawn.There is a rare risk of infection where the needle enters the skin.Triamcinolone acetonide treatment: Side effects with this steroid are not very common.However, side effects of a shot in your muscle have been reported, including atrophy (a“dimple”) at the injection site and changes in skin color. These side effects are kept low byplacing the drug deep into the muscles. All triamcinolone shots will be given by anexperienced member of the study staff. Side effects in the body after a single shot oftriamcinolone are rare. However, with continuous or repeated use, muscle weakness, bonefractures, ulcers, impaired wound healing, and growth suppression may occur. To lower theserisks, you will be screened thoroughly by a physician for the likelihood of side effects beforethe shot is given. We will tell you what problems to look for and we will call you within 72hours to make sure that you are OK. Also you will have 24-hour access to an on-callphysician while you are participating in this study.Risk of disclosure: Your research samples and data will not be labeled with your name orother items that might identify you. All data will be stored in a password protected, studyspecific database and will be labeled with a code number. There will be very limited access tothe link between your name or other personal information and the study code. Because thislink will exist, there is a small risk that your name may become known in association with thisresearch study.Methacholine challenge: During this procedure you may experience asthma symptomssuch as shortness of breath, wheezing, tightness or cough. You will be given severalpuffs of an albuterol inhaler for relief of symptoms. The symptoms are usually gonewithin a few minutes after using the medication.What are the Benefits of Study Participation?You are not guaranteed any benefit from participation in this study. Your participation inthis study will help researchers understand more about severe asthma. The results fromthis study may help us find a better way to treat asthma and may benefit other asthmapatients in the future.Will I be Paid for My Participation?You will be paid for your participation. The amount you receive depends on which parts ofthe study you complete. If you qualify for the study after screening and complete thestudy visits outlined in this consent form, you will be paid up to $795. If you stopparticipating before the end of the study or if the study is discontinued through no fault ofyours, you will receive a partial payment based upon your participation in the study.Visit Description Approximate Length ReimbursementVisit 1a 2.0 hrs $100Visit 1b (if needed) 1.0 hr $50SARP 3 Main Consent V1 10-17-12Page 5 of 13IRB Approval Date: 10/16/2012Date IRB Approval Expires: 10/15/2013FWA00005399 HS IRBUniversity of Wisconsin – Madison