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Clinical Trials at the AAARC Clinical research initiatives at the AAARC include AAARC-initiated studies of potential asthma and allergy treatments, as well as clinical research trials for pharmaceutical companies developing new asthma and allergy medications. The University of Pittsburgh Institutional Review Board (IRB) reviews all protocols involving human patients to help ensure patient safety and welfare to the highest extent possible in each study. A team of research specialists performs trials at the AAARC's Asthma Clinical Research Center under the supervision of a nurse-manager. The center includes laboratory space and adjoining offices for the collection and processing of clinical materials. The laboratories employ computerized pulmonary function equipment that provides rapid processing and analyses. Staff routinely perform standard pulmonary function, methacholine and allergen challenges, and allergy skin testing. In the offices, center staff screen prospective subjects through telephone interviews. Subsequent preliminary testing assesses volunteers' eligibility for inclusion in experimental clinical trials of investigative allergy or asthma therapies. A database of more than 5,000 potential subjects from the western Pennsylvania area has been developed to support these studies. Furthermore, close collaboration with the Division of Pulmonary, Allergy, and Critical Care Medicine allows rapid referral of patients who might benefit from AAARC clinical trials. Additional subject recruitment is performed through advertisements in area newspapers, periodicals, local postings, and radio. Current Clinical Trials AstraZeneca Pulmicort Turbohaler Study The aim of this study is to compare two types of inhalers used to administer the medication, Pulmicort® (Budesonide). Pulmicort® is administered via a type of inhaler called a Turbohaler® (M0), which is FDA approved. AstraZeneca has made changes in to the turbohaler in attempts to make it better. This study compares these two turbohalers to determine which is the more efficient method of administering Pulmicort. This study will be conducted over a 12-16 week period and will include 6 visits to the Asthma Research Center. During the study, participants will have physical exams performed by a doctor, pulmonary function testing at each visit and will be provided Ventolin® as a rescue inhaler. Blood draws are also a part of this study. Patients in this study are asked to keep track of their daily symptoms and medication administration on a personal handheld device known as a PalmPilot. PalmPilots will be provided to each patient for use during the trial. Upon completion, participants will be compensated $500. To be qualified for this study, you must meet the following criteria:
This study is comparing two existing FDA approved asthma medications as the best first line therapy for asthma, requiring daily treatment. The two medications being compared are Flovent® (Fluticasone propionate) and Singulair® (Montelukast). The study will be conducted over a 15-month period, and involves 5 office visits (some visits are multiple day visits) to the Asthma Research Center. The study also involves a procedure known as a research bronchoscopy. During a bronchoscopy, an attending physician will use a bronchoscope, which is a thin, flexible, fiberoptic scope about half the size of a pencil in diameter, and will pass the bronchoscope through your nose, down to your throat and into your lungs. You will be awake for this procedure but you will have been given medication to relax you and to numb your nose and throat. Participants will be compensated $1580 upon completion of the study. To qualify for the research study you must meet the following criteria:
This clinical asthma trial is comparing two FDA approved medications, Advair® and Flovent®, which are both diskus inhalers. This study is being conducted to evaluate whether asthma, and the symptoms that go along with asthma, can be controlled with a lower dose of inhaled corticosteroids using Advair® instead of Flovent®. Advair® is a combination inhaler that provides an inhaled corticosteroid, Flovent®, in a lower dose because it is paired with Serevent®, a long-acting bronchodilator. Participation in this study will last about 42 weeks and consist of 7 visits to the Asthma Research Center. During the study, participants will receive physical exams from physicians, pulmonary function testing and Ventolin to use as rescue medication. Upon completion, participants will be compensated $325 for their time and travel. Participation is contingent upon the following criteria:
Severe Asthma Research Program (SARP) Most asthmatics are able to control their symptoms with medications, like inhaled corticosteroids. However, there are some who cannot regain control even with the use of medications. The SARP program’s specific goal is to determine the mechanisms behind why some asthmatics cannot control their asthma using normal medication therapies, like inhaled corticosteroids. This study is a four-month study that would consist of four visits to the Asthma Research Center. This study is targeting many different categories of asthmatics from mild-to-moderate, stable asthmatics to uncontrolled, severe asthmatics. The study also involves a procedure known as a research bronchoscopy. During a bronchoscopy, an attending physician will use a bronchoscope, which is a thin, flexible, fiberoptic scope about half the size of a pencil in diameter, and will pass the bronchoscope through your nose, down to your throat and into your lungs. You will be awake for this procedure but you will have been given medication to relax you and to numb your nose and throat. Subjects will be compensated $200 for the participation at the time of study completion. To be qualified for this asthma study, you must meet the following criteria:
This COPD trial is comparing the effects of two medications on the symptoms of COPD, including coughing, nighttime awakenings and wheezing. Both medications belong to a class of medications known as long-acting brochodilators. One of the medications, Serevent®, is FDA approved. The other medication, (R,R) Formoterol, is an investigational medication. This particular study is actually an extension to a study that was conducted at our clinic last winter. This study is a 10-month study that involves 10 visits to the Asthma Research Center. During the course of this study, participants will receive physical exams from doctors, EKGs and pulmonary function testing at every visit and rescue medication to use throughout the trial. The patients will be asked to keep track of their daily symptoms, medication usage and their peak flow reading, using a peak flow meter provided to them, throughout the course of the trial. Smoking patients are eligible for this trial. If you do not have a diagnosis of COPD but suspect that you may, our physicians would have to actually find that you do have a diagnosable case of COPD for you to be eligible for this trial. Other criteria participants have to meet are as follows:
For information on becoming a clinical research study participant,
call 412-647-0778.
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