N-Acetylcysteine nebulization administered early in the course of the Acute Respiratory Distress Syndrome Save

Date Added
February 3rd, 2017
PRO Number
Pro00059094
Researcher
Judson Lewis
Keywords
Breathing, Drug Studies, Lung, Pulmonary
Summary

The acute respiratory distress syndrome (ARDS) affects 150,000 people in the US. Because of these mechanical abnormalities of the lung, ARDS patients may require mechanical ventilation. Patients with ARDS that are on mechanical ventilation have a 50% mortality rate. The overall objectives of this study are to demonstrate whether a protocol for the early use of inhaled N-acetylcysteine improves patient care and hospital stay.

Institution
Palmetto
Recruitment Contact
Alisha Henderson
803-545-5453
alisha.henderson@uscmed.sc.edu

Evaluation of COPD Co-Pilot™ Save

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

A prospective observational study in cystic fibrosis patients with chronic respiratory Pseudomonas aeruginosa infection treated with TOBI® Podhaler™ (tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal antibacterial drugs Save

Date Added
February 23rd, 2016
PRO Number
Pro00044578
Researcher
Patrick Flume
Keywords
Adolescents, Breathing, Cystic Fibrosis, Lung, Pulmonary
Summary

You are invited to volunteer for this non-interventional study if you have been prescribed tobramycin inhalation powder (TOBI® Podhaler™) or another inhaled medication used to treat Cystic Fibrosis (CF) related Pseudomonas aeruginosa (bacteria).

The purpose of this non-interventional study is to assess how well TOBI Podhaler or other approved inhaled antibiotic medications work on treating this bacterium in the lungs, and their safety as used in medical practice. A non-interventional study is a study in which individuals are only observed and certain outcomes are measured. The study will entail around 20 visits over the course of 5 years.

Institution
MUSC
Recruitment Contact
Ashley Warden
843-792-4349
jonesash@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 early-stage lung cancer survivors 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 survivors.

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
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

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

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

Alpha-1 Coded Testing Study (Pilot ACT Study) Save

Date Added
October 5th, 2009
IRB Number
9556
Researcher
Charlie Strange
Keywords
Asthma, Breathing, Liver, Lung, Pulmonary, Rare Diseases, Shortness of Breath
Summary

Alpha-1 Antitrypsin Deficiency (Alpha-1) is a hereditary condition that is passed on from parents to their children through genes. This condition may result in serious lung disease in adults and/or liver disease in infants, children and adults.
Alpha-1 occurs when there is a severe lack of a protein in the blood called alpha-1 antitrypsin (AAT) that is mainly produced by the liver. The main function of AAT is to protect the lungs from inflammation caused by infection and inhaled irritants such as tobacco smoke.
The low level of AAT in the blood occurs because the AAT is abnormal and cannot be released from the liver at the normal rate. This leads to a build up of abnormal AAT in the liver that can cause liver disease. Finding out the test results early may affect the onset and progression of the disease.

The Alpha-1 Coded Testing (ACT) Study offers free and confidential finger stick testing for Alpha-1 Antitrypsin Deficiency. The test can be completed at home and results are mailed to the participant's home. This test is available through a research study, the Alpha-1 Coded Testing (ACT) Study. The Study investigates people's thoughts and feelings about the risks and benefits associated with learning genetic information. Anyone over age 18 can request to be tested. Participants or the participant's guardian must sign a consent form, fill in a questionnaire, and allow for recontact in the future. Full details are available in the consent form.

Institution
MUSC
Recruitment Contact
Laura Schwarz
843-792-0260 or 1-877-886-2383
alphaone@musc.edu

Alpha-1 Foundation Registry Save

Date Added
October 5th, 2009
IRB Number
9059
Researcher
Charlie Strange
Keywords
Asthma, Breathing, Liver, Lung, Pulmonary, Rare Diseases, Shortness of Breath
Summary

The Alpha-1 Research Registry is a confidential database of individuals with Alpha-1 Antitrypsin Deficiency (Alpha-1) or a carrier phenotype. Alpha-1 is a genetic disorder associated with chronic obstructive pulmonary disease (COPD) and liver disease. The goal of the Registry is to facilitate Alpha-1 research by providing investigators with a group of Alphas and carriers willing to consider participation in research. Because the clinical, basic science and epidemiological research agenda in Alpha-1 Antitrypsin Deficiency is moving at a rapid pace, patient participation in research has never been more critical than it is today. Since Alpha-1 is a rare disease, the ability to contact a large number of Alphas increases the likelihood of research in Alpha-1 and the Registry's desirability as a study tool. Your participation aids us in the common goal to find a cure for Alpha-1 Antitrypsin Deficiency.

WHO IS ELIGIBLE?
Membership in the Alpha-1 Research Registry is currently open to individuals with Alpha1-Antitrypsin Deficiency (AAT Deficiency or Alpha-1) and to carriers of the alpha1-antitrypsin (AAT) gene. Individuals unsure of their Alpha status should consider free confidential testing through the Alpha Coded Testing Trial.

If you know you have Alpha-1 or are a carrier of the AAT gene but do not know your phenotype (the individual letters of the Alpha-1 genes), the Registry staff is happy to speak with you and facilitate phenotyping if necessary.

Institution
MUSC
Recruitment Contact
Eryn Varano
843-792-1219
alphaone@musc.edu

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