Search Results Within Category "Lung Disease & Asthma"
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis
A phase 3 clinical trial to investigate the effectiveness and safety of a study drug in subjects in Idiopathic Pulmonary Fibrosis
You will be required to attend 8 in-person visits at the Hershey Medical Center over the span of approximately one year. During the study you will have physical examinations, complete questionnaires, review your medical history and current medications, have vital signs and ECGs taken, have blood tests performed, complete pulmonary function testing, and potentially have a high resolution CT scan done. You will take the inhaled treprostinil or placebo daily at home throughout the study.
Diagnosed with Idiopathic Pulmonary Fibrosis
Female participants who are pregnant or lactating
Receiving more than 10 L/min of oxygen supplementation at rest
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of DWN12088 in Patients With Idiopathic Pulmonary Fibrosis
A Phase 2 Clinical Trial to assess whether study drug DWN12088 is safe and effective in Patients With Idiopathic Pulmonary Fibrosis
During this study, you will be asked to come to in-person visits at the Hershey Medical Center over a period of 6 months During that time you will visit the study center 8 times and have various tests done including: signing informed consent, providing demographics, having a chest CT scan, reviewing medical history, having a physical exam done, having vital signs and an ECG taken, having bloodwork done, receiving study drug, receiving patient diaries, having study drug administered, performing lung function tests (spirometry, DLCO and 6-minute walk test), and completing questionnaires.
Diagnosed with idiopathic pulmonary fibrosis in the past 5 years
Able to walk 150 meters (492 feet) in 6 minutes
Lower respiratory tract infections requiring antibiotics in the last 4 weeks
Female participants who are pregnant or nursing
Use of investigational drugs for idiopathic pulmonary fibrosis in the last 4 weeks
A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects with Progressive Pulmonary Fibrosis (TETON-PPF)
This is a drug study that will examine if inhaled treprostinil is save and effective in people diagnosed with Progressive Pulmonary Fibrosis.
You will be required to attend 8 in-person visits at the Hershey Medical Center over the span of approximately one year. During the study you will have physical examinations, complete questionnaires, review your medical history and current medications, have vital signs and ECGs taken, have blood tests performed, complete pulmonary function testing, and potentially have a high resolution CT scan done. You will take the inhaled treprostinil or placebo daily at home throughout the study.
600
Evidence of progression of pulmonary fibrosis in the last 24 months
Evidence of obstructive pulmonary disease
Concomitant use of both nintedanib and pirfenidone is not permitted
Received any PAH-approved therapy in last 60 days
Receiving >10 L/min of oxygen supplementation
A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency–Associated Liver Disease With METAVIR Stage F2 to F4 Fibrosis
This research study of fazirsiran (FAZ-i-sir-an; also called TAK-999 or the “study drug”) because you have alpha-1 antitrypsin deficiency-associated liver disease (AATD LD) with METAVIR stage F2 to F4 fibrosis (METAVIR is a system used to score the amount of inflammation and fibrosis seen in a liver biopsy). In AATD, abnormal (Z-AAT) proteins build up in liver cells, leading to varying amounts of liver problems. The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis
-The total amount of time you may be involved in the study is about 4 ½ years (230 weeks). -Screening Period of up to 70 days. -Treatment Period of 196 weeks or about 4 years. During the study, you will get the study drug or placebo at the study site. -Follow-up Period of 6 months. You will have visits 6, 12, and 24 weeks after your last injection of the study drug or placebo. -You will have lung function tests (PFT and DLCO) to check how your lungs are working At every visit during the treatment period you will have: -Your vital signs will be measured, this includes your heart rate, blood pressure, breathing rate, temperature, and amount of oxygen in your blood. -You will have a brief physical exam. -Your weight will be measured. -You will have an ECG. -Collect lab samples During specific study visits during the treatment period the following tests will be performed: -An abdominal ultrasound -FibroScan -CT scans You will complete questionnaires.
The participant must use highly effective contraception
The participant must have suitable vein access for blood sampling
Participant agrees not to smoke at any time during the study.
The participant must have a diagnosis of the PiZZ genotype AATD
The participant has a recent lower respiratory tract infection, such as pneumonia, within the last 6 months before screening.
The participant is expected to have severe and unavoidable high-level exposure to inhaled pulmonary toxins during the study such as may occur with occupational exposure to mineral dusts or metals.
The participant has a history of malignancy within the last 5 years
The participant has evidence of other forms of chronic liver diseases
A PHASE 2, SINGLE ARM, OPEN LABEL EXTENSION STUDY, EVALUATING THE LONG-TERM SAFETY AND CLINICAL EFFICACY OF INBRX-101 IN ADULTS WITH ALPHA-1 ANTITRYPSIN DEFICIENCY (AATD) EMPHYSEMA
The study will test INBRX-101 as an experimental drug to treat patients with Alpha-1 antitrypsin deficiency. “Experimental” means the drug has not been approved by any authority that regulates new medications, including the US Food and Drug Administration. Therefore, it can only be used in a research study. INBRX 101 is an artificial form of Alpha-1 antitrypsin that has been altered to last longer in the body. This means that INBRX-101 could be given less frequently than the currently approved augmentation therapies for this condition because it works for longer in the body. Its purpose is to understand the safety and therapeutic effects of INBRX-101 over 3 years. All patients in this study will receive only INBRX-101.
You will visit the study site for blood sampling, computed tomography (CT) scan, lung function tests, electrocardiograms (ECGs), study drug administration and questionnaire completion. Some visits may be completed with assistance from a home healthcare organization. The study will last approxiately 3 years.
Diagnosis of Alpha-1 Antitrypsin Deficiency
Evidence of emphysema related to alpha-1 antitrypsin deficiency
Current non-smoking status
Alpha-1 Antitrypsin Deficiency genotype of Pi*ZZ, Pi*ZNull, Pi*MaltonZ, Pi*NullNull, or Pi*Mheerlen.
On waiting list for lung or liver transplant
Active cancers or has a history of cancer within 5 years prior to screening
Current substance and/or alcohol abuse
A Survey to Estimate the Socio-Economic Impact of the Novel Corona Virus (COVID-19) Pandemic
We are experiencing global outbreak of coronavirus (COVID-19) recently. Millions of people are suffering and dying every day, in spite of putting our best efforts. We are doing this survey to understand people’s reaction to this situation. The survey will ask about your knowledge, practices and worries. Your response will help us to understand how to better control these situations. Your feedback is highly important to us, as we need to find out the best way to stop the disease from spreading and killing thousands of lives, and to reduce the stress among the population.
Adult
Mentally impaired
Participants from Europe or European Union (EU)
Recruitment for Nicotine and Tobacco Related Research at Penn State Hershey
The purpose of this project is to screen potential participants for multiple research studies being conducted by tobacco researchers at Penn State Hershey. Since there are multiple IRB approved studies enrolling at Penn State Hershey with similar but not identical inclusion/exclusion criteria, it is more efficient for the researchers and participants to have one phone number to call initially for basic screening. After completing this, the participant can be redirected for more specific screening if they are found to be potentially eligible for one of the studies.
Participants will fill out a 5-minute survey on tobacco use in order to find out which study they may be eligible for.
Depends on study
Current tobacco user