A Safety Study for Women with Sporadic or TS-associated LAM.
Sponsor: LAM Foundation:Investigator Initiated.
The SOS (Safety Study of Simvastatin in Patients with Sporadic Pulmonary Lymphangioleiomyomatosis (LAM) and LAM Associated with Tuberous Sclerosis Complex) Trial is a research study to determine the safety of simvastatin in combination with a stable dose of either sirolimus or everolimus in patients with LAM. Simvastatin is widely used and approved by the US Food and Drug Administration (FDA) to reduce blood cholesterol and lower the risk of stroke, heart attack, and other heart complications, in people with diabetes and coronary heart disease. Currently, the use of simvastatin to treat LAM and TSC patients is experimental and has not been FDA approved.
The study involves 6 scheduled visits occurring approximately every 30 days, over about a 5 month period. Women who are eligible to participate and enroll in the study will receive simvastatin as part of this study for four months. At the end of the treatment period, participants will complete a final set of surveys and questioning. One month after completing the final study visit, participants will be contacted by telephone to see how they are doing.
The Effects of Ozone on Prostaglandin Secretion and Pulmonary Function Tests in Mild Persistent and Intermittent Asthmatics.
Sponsor: Investigator Initiated.
The purpose of this research study is to look for early markers of inflammation in the urine, sputum and blood in a population of asthmatics. We will investigate the markers that appear on the cells from your lungs after they have been exposed to ozone (a colorless gas made up of three oxygen atoms) and compare them with the markers that are there when you are breathing normal air. The use of ozone in this study is experimental.There will be five visits over a 6 week period. Approximately 20 adult male and female volunteers with asthma and 20 healthy subjects are expected to participate in this study over about one year.
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy and Safety of Grass (Phleum pratense) Sublingual Tablet (SCH 697243) in Subjects Between 5 and 65 Years of Age, with a History of Grass Pollen-Induced Rhinoconjunctivitis, With or Without Asthma
The purpose of this study is to compare how safe and effective the study drug, SCH 697243, is when compared to a placebo (look-alike with no active ingredients, sometimes called a sugar pill) in treating rhinoconjunctivitis (an allergic reaction to grass pollen that causes nose [itching, runny nose, stuffy nose, sneezing] and eye symptoms [red eyes, itchy eyes, watery eyes]) when taken once daily. The study drug will be given as a sublingual tablet. A sublingual tablet is a pill that quickly dissolves when placed under the tongue.
SCH 697243 is also known as Grass AIT (Allergy Immunotherapy Tablet)/GRAZAX) and has been approved in 30 European countries. However, the study drug is still investigational (being tested for use) for sites outside of the European countries.
Around 1,500 subjects will take part in this trial at about 200 different study sites in the United States and Canada. The study doctor expects to enroll up to 8 individuals at the University of Pennsylvania site. Subjects will be in the study for up to 15 months and will attend about 7 study visits.
Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma
Sponsor: Boston Scientific Corporation
This study is designed to evaluate the short- and long-term benefit and safety of a procedure called bronchial thermoplasty (which is performed with the Alair® System) for the treatment of severe persistent asthma. The Alair® Bronchial Thermoplasty System is indicated for the treatment of severe persistent asthma in patients 18 years and older whose asthma is not controlled bystandard drug treatments. The Alair® System uses heat energy to reduce the amount of smooth muscle present in the airways. In a recent clinical study lasting one year, bronchial thermoplasty has been shown to reduce asthma attacks and visits to the emergency room for respiratory symptoms, and improve quality of life in patients with severe persistent asthma. It is not known how long this benefit will persist.
The anticipated number of subjects involved in the study will be between 250 and 300 at 30 centers across the United States. The University of Pennsylvania will enroll up to 20 subjects per year. The length of time for your participation is approximately five and a half years.
Efficacy and Biomarker Discovery of Vitamin D3 in the Management of Moderate and Severe Asthma
Sponsor: Investigator Initiated
The purpose of this study is to investigate the effect of vitamin D on the function of the lungs and markers of inflammation in the blood and mucus of individuals who have moderate to severe asthma.
We will examine people who have moderate to severe asthma both before and after treatment with vitamin D. Blood and airway mucus (sputum) will be collected before and after treatment with vitamin D to compare markers of inflammation. Comparing markers of inflammation and other molecules in the blood and lungs of people with asthma may help researchers better understand inflammation in the lung and whether vitamin D treatment might be helpful to improve the control of asthma.
Your participation in this study will last approximately 4 months. Approximately 40 adult male and female volunteers are expected to participate in this study.
A Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of MEDI-563 in Subjects with Moderate-to-Severe Chronic Obstructive Pulmonary Disease and Sputum Eosinophilia
The purpose of this study is to see if MEDI-563, given as one injection under the skin in each arm, can help reduce the number of exacerbations that you experience as part of your COPD. The study will also help to determine the safety of MEDI-563. You will have your blood tested, your vital signs (temperature, blood pressure, pulse rate, breathing rate) checked, and medical examinations. Other tests will be done to see what effect MEDI-563 has on your use of medications to control your COPD, the airflow through your lungs, your quality of life, and your ability to perform certain activities. In addition, the study is being done to see how much MEDI-563 is in your blood after taking it.
The information learned in this study may be helpful in the further development of MEDI-563 for the treatment of COPD.
The planned length of time you will be in the study including follow-up is 88 weeks.
There will be about 90 people in this study. This study will be carried out at about 15 sites. Four subjects will be enrolled at the University of Pennsylvania.
Epigenetic Signatures of Airway Inflammation After Oxidative Stress in COPD Subjects
Sponsor: Investigator Initiated
The purpose of this research study is to obtain sputum (also called mucus or phlegm) from subjects with COPD and smokers who do not have COPD. The sputum will be used to assess whether certain molecules (small particles) found in the sputum indicate lung tissue damage and the extent of that damage. We will investigate the markers that appear on the cells from your lungs after they have been exposed to ozone (a colorless gas made up of three oxygen atoms) and compare them with the markers that are there when you are breathing normal air. The use of ozone in this study is experimental. This research may help in the development of a new drug to treat COPD.
Your participation in this study will last approximately 6 weeks.
Approximately 20 adult male and female volunteers with COPD and 10 healthy smokers are expected to participate in this study over about one year.
A Cross-Sectional Study of Surfactant Protein D (SP-D) as a Modulator of Lung Inflammation and COPD Pathogenesis
The purpose of this study is to investigate the differences in the function of the lungs between individuals who have COPD (chronic obstructive pulmonary disease, a lung disease caused by smoking that decreases airflow in the lungs and causes shortness of breath) and individuals without lung disease.
We will examine people who have COPD and healthy people with no lung disease, and compare the amount of a protein in the lung called surfactant protein D. Surfactant protein D is a naturally occurring protein in the lung that helps your lungs fight off infection and also affects inflammation in the lung. Comparing surfactant protein D and other molecules in the lungs of people with COPD and healthy people may help researchers better understand inflammation in the lung and develop new medicines to treat COPD.
Your participation in this study will last approximately 1 week if you do not participate in the COPD substudy and about 3 weeks if you do participate in the COPD substudy.
Approximately 200 adult male and female volunteers are expected to participate in this study over about four years. It is anticipated that 100 of the participants will be COPD patients and 100 of the participants will be healthy volunteers.
PENN REGISTRY FOR AIRWAYS DISEASE RESEARCH (RADR) PROTOCOL
The purpose of this study is to create a “registry,” or detailed record, of patients seen at the Penn Lung Center with either asthma or chronic obstructive pulmonary disease (COPD, also known as emphysema or chronic bronchitis). Research subjects who are healthy or who have asthma or COPD may also participate if they take part in studies at the Airways Biology Initiative (ABI) at Penn Presbyterian Medical Center. The reasons for doing this are many. One reason is to have some information about you so that, if a study or new treatment comes along for which you may qualify, we will be able to find you and offer it to you. This registry will also help us to learn more about asthma and COPD, how they develop, and how best to treat them. Your data and samples will also be used to study other medical disorders, such as nicotine addiction and lung cancer.
There are two parts to the study: (1) a Patient Information Database and (2) a Specimen Repository (blood and/or urine sample collection). You may choose to participate in both, or to participate in the Patient Information Database, alone. If you choose to participate in this study, your involvement in this study will not affect the care that you receive and will not require you to have additional tests other than those your doctor would order anyway for the purposes of your care.
Patient Information Database:
Participation in the Patient Information Database involves (1) completing a questionnaire on the day you join the study, asking you about your present symptoms, past medical history, family history, and history of tobacco use (about 15 minutes of your time), (2) completing a brief follow-up questionnaire about every 6 months (when you return to see your doctor at the Penn Lung Center), asking you to update your present symptoms, medical history and use of tobacco (about 7 minutes of your time), (3) having your medical chart reviewed by research staff at each visit to obtain other information about your medical history and results of tests already performed by your health care providers (requires none of your time) and (4) a telephone contact which is optional.
Participation in the Blood Repository (blood sample collection) involves having a small needle placed in a vein in your arm by a person experienced in this procedure to collect about 3 tablespoons (up to 50 milliliters) of blood. This procedure will take about 10 minutes and will only be performed once. You will be asked to report any symptoms that you may have during and immediately after the blood is collected.
Participation in the Urine Repository involves the collection of about 75 milliliters (about a quarter cup) of your urine.
In the Human Respiratory Tract Microbiome Research Study conducted at the University of Pennsylvania, researchers will examine the functions of cells and micro-organisms (such as bacteria, viruses, and fungi) that live in the nose, mouth and lungs of healthy smokers and non-smokers over the age of 18 and COPD non-smokers (former smokers are OK) over the age of 18.
Visits will include 3 visits within 30 days (Screening/Baseline, chest CT, bronchoscopy).