Scleroderma Lung Study III (SLS III): Combining the anti-fibrotic effects of pirfenidone (PFD) with mycophenolate (MMF) for treating scleroderma-related interstitial lung disease Save

Date Added
May 8th, 2018
PRO Number
Pro00077568
Researcher
Richard Silver

Silhouette
Keywords
Autoimmune disease, Drug Studies, Lung, Scleroderma, Shortness of Breath
Summary

This study will assess how 18 months of oral mycophenolate will compare to 18 months of mycophenolate plus pirfenidone, in the treatment of Systemic Sclerosis related Interstitial Lung Disease. Tolerability and toxicity will also be assessed, during this study.
This research is designed to test whether combining pirfenidone and mycophenolate will result in a more rapid and possibly greater improvement in lung function than occurs when mycophenolate is used alone. While both of these drugs have been approved by the U.S. Food and Drug Administration (FDA) to treat other medical conditions, neither drug has been FDA-approved for the treatment of scleroderma related lung disease. This research is being funded by the drug company, Genentech.

Institution
MUSC
Recruitment Contact
Kelley Kajdasz
843-792-5290
gibsonke@musc.edu

RESP-FIT: Technology-Enhanced Self-Management in COPD Save

Date Added
January 2nd, 2018
PRO Number
Pro00071706
Researcher
Sarah Miller

Silhouette
Keywords
Breathing, Lung, Pulmonary, Shortness of Breath
Summary

30 adults, aged 40 and older with mild to moderate COPD, will be recruited for this study. Participants must be willing to continually wear a FitBit activity monitor, have access to a smartphone or Wi-Fi/Data-enabled iPad, and be willing to complete respiratory muscle strength training exercises as well as reports on their smartphone at least 5 times per week for a 6-week period. Participants will be given a bluetooth inhaler device and a training app (RESP-FIT). This application will collect inhaler data and allows patients to self-report their daily symptoms. The goal of this study is to test whether use of the personalized inhaler device with the app strengthens lung function, promotes physical activity, and improves disease symptom self-management in persons with COPD.

Institution
MUSC
Recruitment Contact
Lisa Heidelberg
8437927309
heidelbe@musc.edu

Early Intrapleural TPA Instillation Versus Late (ELEVATE) Save

Date Added
February 17th, 2017
PRO Number
Pro00058518
Researcher
Rohan Arya
Keywords
Cancer/Lung, Drug Studies, Infectious Diseases, Lung, Pulmonary, Shortness of Breath
Summary

When a chest tube is placed, it can be hard for the fluid to drain. Tissue plasminogen activator and DNase are given through the chest tube to help with draining the fluid. We are doing this research to see if early addition of tPA-DNase will help with better fluid draining.

Institution
Palmetto
Recruitment Contact
Rohan Mankikar
803-352-1237
rohan.mankikar@palmettohealth.org

Evaluation of COPD Co-Pilot™ Save

Date Added
December 20th, 2016
PRO Number
Pro00058066
Researcher
Tatsiana Beiko

Silhouette
Keywords
Breathing, Lung, Shortness of Breath
Summary

This is an observational, unblinded, single group study. All study participants will be provided with the COPD Co-PilotTM application, as well as a peak flow meter and device for accessing the application. Patients will be trained in use of the application and phone device by a health care professional. Patient records including costs will be collected during the study, to include clinic visits, admissions, and emergency department visits and collected retrospectively from January 1, 2015 through enrollment. All analysis of patient compliance and utilization parameters will be completed retrospectively.

Institution
MUSC
Recruitment Contact
Danielle Woodford
8437926280
woodfordd@musc.edu

A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multiple-Dose, Proof of-Concept Study to Evaluate the Efficacy and Safety of Hyaluronic Acid Inhalation Solution for the Treatment of Hereditary Emphysema in Patients with Alpha 1-Antitrypsin Deficiency for 28 days Save

Date Added
March 8th, 2016
PRO Number
Pro00051339
Researcher
Charlie Strange

Silhouette
Keywords
Breathing, Lung, Pulmonary, Rare Diseases, Shortness of Breath
Summary

Individuals with a confirmed diagnosis of alpha-1 antitrypsin (AAT) deficiency and emphysema will be invited to participate in this study. This study will determine the safety and effectiveness of Inhaled Hyaluronic Acid solution as a possible treatment of emphysema in AATD patients. A participant in this study will be asked to inhale the study medication or a placebo delivered by a nebulizer twice a day for 28 days. Neither the study investigators nor the participant will know if they are receiving active drug or placebo. Safety and side effects of all therapies will be monitored.

Institution
MUSC
Recruitment Contact
M. Gwen Blanton
843-276-4523
blantonm@musc.edu

Reducing Lung Cancer Survivors' Anxiety (RELAX) Save

Date Added
February 1st, 2016
PRO Number
Pro00051586
Researcher
Patricia Griffin
Keywords
Anxiety, Breathing, Cancer, Cancer/Lung, Shortness of Breath
Summary

The purpose of this research study is to determine ability to recruit lung cancer patients who have completed cancer treatment to a study of a device that may decrease anxiety. Researchers then will determine how many will complete the sessions using the study device as well as all study questionnaires. They will also compare effects of device-guided breathing on anxiety and shortness of breath in lung cancer patients.

Institution
Spartanburg
Recruitment Contact
Clinical Research Department
1-800-486-5941
research@srhs.com

A Phase 3/4 Study to Evaluate the Safety, Immunogenicity, and Effects on the Alpha1-Proteinase Inhibitor (A1PI) Levels in Epithelial Lining Fluid Following GLASSIA Therapy in A1PI-Deficient Subjects Save

Date Added
January 12th, 2016
PRO Number
Pro00046425
Researcher
Charlie Strange

Silhouette
Keywords
Breathing, Lung, Pulmonary, Rare Diseases, Shortness of Breath
Summary

Individuals with alpha-1 antitrypsin (AAT) deficiency (AAT blood level lower than 11 micro-moles) and emphysema will be invited to participate in this study. This study will determine the impact of IV Alpha-1 proteinase inhibitor (Alpha-1 MP) on the progression of emphysema in patients with AAT deficiency. A participant in this study would receive either GLASSIA dosed at 60mg/kg with a high particle load or GLASSIA dosed at 60mg/kg with a low particle load. Neither the study investigators nor the participants will know which batch of drug is actual given to the participant. Participants will have the IV therapies given to them weekly for 25 weeks, with some infusions given at MUSC and some at home. Safety and side effects of all therapies will be monitored.

Institution
MUSC
Recruitment Contact
M. Gwen Blanton
843-792-8438
blantonm@musc.edu

WFU 01213 - Reducing Lung Cancer Survivors' Anxiety and Dyspnea (RELAX) Save

Date Added
December 15th, 2015
PRO Number
Pro00050437
Researcher
Mark O'rourke
Keywords
Anxiety, Breathing, Cancer, Cancer/Lung, Cancer/Other, Lung, Mental Health, Pulmonary, Shortness of Breath
Summary

Patients who have had lung cancer and are experiencing anxiety and possibly shortness of breath may be eligible to participate in the this study.

If you take part in this study, you will be randomized into one of the three study groups described below. Randomization means that you are put into a group by chance. It is like flipping a coin. You will have an equal chance of being placed in any group.

Group A: Will receive a device that will gradually slow down breathing rate. It plays music through headphones and has a sensor that attaches to your abdomen or chest. You will be asked to use it once per day for 15 minutes, at least 5 days per week, for 12 weeks.
Group B: Will receive a device that will gradually slow down breathing rate. It plays music through headphones and has a sensor that attaches to your abdomen or chest. You will be asked to use it twice per day for 15 minutes, at least 5 days per week, for 12 weeks.
Group C: Will receive a device that will leave your breathing rate at a similar rate that you usually breathe. It plays chimes through headphones and has a sensor that attaches to your abdomen or chest. You will be asked to use it once per day for 15 minutes, at least 5 days a week for 12 weeks.

Study participation lasts about 12 weeks.

Institution
Greenville
Recruitment Contact
Gina Norris
864-242-2762
GNorris@ghs.org

Alpha-1 Foundation Clinical Resource Center (CRC) Research Registry Save

Date Added
November 18th, 2014
PRO Number
Pro00026071
Researcher
Charlie Strange

Silhouette
Keywords
Asthma, Breathing, Environmental Factors, Genetics, Liver, Lung, Pulmonary, Rare Diseases, Shortness of Breath
Summary

The purpose of the Alpha-1 Foundation Clinical Resource Center (CRC) Research Registry is to collect and store medical information from individuals with alpha-1 antitrypsin deficiency (AATD or Alpha-1) or individuals that carry a deficient Alpha-1 gene. The Registry will collect medical information on your disease and diagnosis. This information will include family history, lung and liver symptoms, and exposure to cigarette smoke, dusts and fumes.The goal of this project is to obtain and share information that defines the natural history of alpha-1 antitrypsin deficiency. Biological samples from either blood or tissue may be collected and stored as part of this research. This project will assemble a library of these biological samples, some of which will be saved at MUSC.

Institution
MUSC
Recruitment Contact
Eryn Varano
877-886-2383
alphaone@musc.edu

Protocol GTi1201: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Two Dose Regimens (60 mg/kg and 120 mg/kg) of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human) in Subjects with Pulmonary Emphysema due to Alpha1-Antitrypsin Deficiency Save

Date Added
September 9th, 2014
PRO Number
Pro00033459
Researcher
Tatsiana Beiko

Silhouette
Keywords
Breathing, Lung, Pulmonary, Rare Diseases, Shortness of Breath
Summary

Individuals with alpha-1 antitrypsin (AAT) deficiency (AAT blood level lower than 11 micro-moles) and emphysema will be invited to participate in this study. This study will determine the impact of IV Alpha-1 proteinase inhibitor (Alpha-1 MP) on the progression of emphysema in patients with AAT deficiency. A participant in this study would receive any one of the following three therapies: 1) Alpha-1 MP dosed at 60mg/Kg, 2) Alpha-1 MP dosed at 120mg/Kg, or 3) Placebo. Once a subject is enrolled into this study, he/she will be randomly selected to receive only one of the above three therapies. Neither the study investigators nor the participants will know the actual therapy being given to the participants. All the study participants will receive serial chest CT scans to determine if their emphysema progresses over the following 3 years. Participants will have the IV therapies given to them weekly, with some infusions given at MUSC and some at home. Safety and side effects of all therapies will be monitored.

Institution
MUSC
Recruitment Contact
Deirdre Walker
843-792-1219
waldei@musc.edu

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