An Open-Label Extension Study of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD) Save

Date Added
March 24th, 2020
PRO Number
Pro00097579
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to assess safety of the study drug, inhaled treprostinil, and the ability to tolerate long-term treatment with the study drug in patients with PH-COPD. The study will also evaluate the effectiveness of the study drug over long-term treatment. Inhaled treprostinil is a medication that will be given to you by a handheld inhalation device (study nebulizer) called the Tyvaso® Inhalation System. The study is estimated to last 2 to 3 years but could be much shorter or longer. Depending on the final number of subjects who participated in the RIN-PH-304 study, either approximately 136 or approximately 314 subjects may be eligible to participate in this study from the U.S. study centers.

Institution
MUSC
Recruitment Contact
April Rasberry
(843) 792-2375
rasberry@musc.edu

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-814 in PiZZ Subjects Save

Date Added
February 25th, 2020
PRO Number
Pro00096021
Researcher
Charlie Strange

List of Studies


Profiles_link
Keywords
Liver, Lung, Pulmonary
Summary

Alpha-1 Antitrypsin (AAT) is a naturally occurring protein involved in the protection of lungs from inflammation. A mutation in the AAT gene (a change in the body's genetic instructions on how to make AAT) causes it to be made incorrectly and very little of it gets into the bloodstream. Severe AAT deficiency (lack of AAT in the blood) causes emphysema, which causes holes in the lungs. This study is being done to learn more about the safety, tolerability and effectiveness of VX-814 in patients with Alpha-1 Antitrypsin Deficiency. There are four groups in the study, one placebo group and three treatment groups with varying doses. This study is double blind with an 80% chance of being assigned to a treatment group and a 20% chance of being assigned to placebo.

Institution
MUSC
Recruitment Contact
Rachel Millan
843-792-0260
millanr@musc.edu

A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis. Save

Date Added
November 26th, 2019
PRO Number
Pro00093149
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This study is being done to compare the safety, effectiveness, and side effects of different doses of the drug being studied, BI 1265162, with a placebo, in subjects with Cystic Fibrosis (CF). You will be in this study for about 7 weeks. This study will involve study procedures such as, physical and chest exams, blood pressure and pulse, electrocardiograms, blood tests, pregnancy urine tests, breathing tests (pulmonary function tests and multiple breath washout tests), and completing a diary and questionnaires. Each dose of the study drug will consist of 2 puffs which will be taken 2 times per day using the Respimat® inhaler. This is an add-on therapy therefore subjects will continue to take their usual medications (including any therapy), and the treatment period for taking this add-on therapy is 4 weeks.

Institution
MUSC
Recruitment Contact
Caroline Brailsford
(843) 792-1820
brailsfo@musc.edu

APPLAUD: A DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PHASE II STUDY OF THE EFFICACY AND SAFETY OF LAU-7B IN THE TREATMENT OF CYSTIC FIBROSIS IN ADULTS Save

Date Added
November 12th, 2019
PRO Number
Pro00094338
Researcher
Bryan Garcia

List of Studies

Silhouette
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this study is to learn more about the effectiveness and safety of the investigational drug called fenretinide (LAU-7b). The FDA has approved the testing of fenretinide in this study. Researchers hope that treatment with fenretinide will preserve lung function by reducing the persistent inflammation in the lung and to improve its capacity to defend against bacteria such as Pseudomonas aeruginosa. The drug will be administered by capsules. Your participation in this study will last approximately 7 months and includes 8 study visits to the study center (which will last approximately 2-5 hours) and 6 telephone calls. The phone calls are expected to last 10-15 minutes and depend on the amount of information you report.

Institution
MUSC
Recruitment Contact
Max Lento
(843) 792-9697
lento@musc.edu

A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Save

Date Added
October 22nd, 2019
PRO Number
Pro00091705
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This study is designed to evaluate ABBV-3067 alone and in combination with ABBV-2222 to see how safe they are and how well they work for treating cystic fibrosis. The study will also help select the minimum effective dose of both medicines. Both drugs are investigational and will be taken orally. Both help to restore Cystic Fibrosis transmembrane conductance regulator (CFTR) activity, which is when there isn't enough water on membrane surfaces for those who have cystic fibrosis. You will either receive the drug or a placebo. The study will be done in approximately 3 months. Approximately 189 patients with cystic fibrosis who are older than 18 years of age will be enrolled in this study.

Institution
MUSC
Recruitment Contact
Brooke Alexander
843-792-1221
alexanbr@musc.edu

A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira™ Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD) (AIRFLOW-3) Save

Date Added
August 27th, 2019
PRO Number
Pro00087312
Researcher
Charlie Strange

List of Studies


Profiles_link
Keywords
Genetics, Lung, Pulmonary, Shortness of Breath
Summary

The primary purpose of conducting this study is to see if TLD (Targeted Lung Denervation) Therapy in addition to standard optimal medical care is better at reducing a moderate or severe exacerbation (also known as a COPD flare-ups or worsening of symptoms) and related hospitalizations than optimal medical care alone. TLD Therapy is done by passing a bronchoscope, with a special device (catheter) inserted through it, into the lungs. This special catheter delivers a type of electrical energy called radiofrequency (or RF) energy to the nerves located on the outside of the airways. As with many bronchoscopic procedures, this is done while under anesthesia. TLD Therapy does cause a permanent change to a person's lungs. To test this, participating patients will be randomly assigned (in a 1:1 ratio) to receive one of two different treatments, either TLD Therapy in addition to optimal medical care or optimal medical care alone.
Some sites, including MUSC, will also be collecting 3 airway brushes to look at inflammatory biomarkers in the lungs. A biomarker is anything that can be used as an indicator of a particular disease state.
If you choose to participate in this study, it is estimated that you will be involved in this study for approximately 62 months. Participation will take around 11 clinical site visits and 9 follow up phones calls over a period of 5 years. The participant and person obtaining consent will sign the informed consent form and the participant will receive a copy before any study procedures occure.

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

Routine Cardiac Screening in Sarcoidosis Patients Save

Date Added
August 20th, 2019
PRO Number
Pro00090373
Researcher
Walter James

List of Studies

Silhouette
Keywords
Lung, Pulmonary, Sarcoidosis
Summary

This is a trial for cardiac sarcoidosis in patients seen during routine clinical care who have not been clinically suspected to have cardiac sarcoidosis according to conventional criteria. The addition of echocardiogram and ambulatory ECG to usual clinical follow-up will be compared. This is a multicenter study, coordinated by the Foundation for Sarcoidosis Research. Up to 12 sites in the US and Europe will participate. Each site will enroll 50 consecutive consenting individuals to a total of 600 enrolled subjects in a randomized trial of additional screening versus usual care.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

Registry for Advanced Sarcoidosis (ReAS) Save

Date Added
August 13th, 2019
PRO Number
Pro00090539
Researcher
Walter James

List of Studies

Silhouette
Keywords
Lung, Pulmonary, Sarcoidosis
Summary

The purpose of this research study registry is to identify patients with advanced sarcoidosis. This is an observational research study, which means you will not take study medication(s). The study will determine how many and how often patients are diagnosed with advanced disease in sarcoidosis clinics. The study will determine how many and how often patients are diagnosed with advanced disease in sarcoidosis clinics. This study will look at genetic markers; determine the risk factors for advanced sarcoidosis and the natural course of symptoms in advanced disease. You will be in the research study for approximately 36 months (3 years)and will be seen every 6 (six) months during the research study.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

A Phase 3, Randomized, Placebo-controlled, Double-blind, Adaptive Study to Evaluate the Safety and Efficacy of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD) Save

Date Added
July 23rd, 2019
PRO Number
Pro00090282
Researcher
Rahul Argula

List of Studies


Profiles_link
Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to evaluate the effectiveness of inhaled treprostinil in improving exercise ability in patients with PH (Pulmonary Hypertension) -COPD (Chronic Obstructive Pulmonary Disease) when compared to an inactive solution, or placebo. This is a 34-week study. Approximately 136 subjects will be enrolled at approximately 60 US centers in the Original Design. If the study is adapted to the Contingent Design, approximately 314 subjects will be enrolled at approximately 80 US centers.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety of Weekly Intravenous Alpha1-Proteinase Inhibitor (Human), Modified Process 60 mg/kg in Subjects With Pulmonary Emphysema Due to Alpha1-Antitrypsin Deficiency Save

Date Added
July 23rd, 2019
PRO Number
Pro00090675
Researcher
Tatsiana Beiko

List of Studies

Silhouette
Keywords
Lung, Pulmonary, Rare Diseases
Summary

Individuals with alpha-1 antitrypsin (AAT) deficiency, emphysema and who have been enrolled in the SPARTA trial will be invited to participate in this study. This is a two year extension of the SPARTA trial for subjects who did not receive the study drug (Alpha 1 Proteinase Inhibitor) and for those who complete the SPARTA trial. Participants will all receive weekly infusions of Alpha-1 MP 60mg/kg either at MUSC or at home with a home health nurse. All participants will have blood work, pulmonary function test and CT scans done as part of this study. Safety and side effects of all therapies will be monitored.

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

Change_preferences

-- OR --

Create_login