A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Save

Date Added
March 27th, 2018
PRO Number
Pro00075578
Researcher
Sylvia Szentpetery

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Keywords
Cystic Fibrosis, Lung, Pediatrics, Pulmonary
Summary

The purpose of this study is to learn more about the long-term safety, tolerability, and effects of the combination of VX-661 and ivacaftor in subjects with Cystic Fibrosis. This is a rollover study from study VX 15-661-113 Part B. Approximately 121 people will participate in this study. Participation could last for approximately 100 weeks. This will include a treatment period that will last up to 96 weeks, and a follow-up period that will last up to 4 weeks.

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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis Save

Date Added
February 27th, 2018
PRO Number
Pro00075593
Researcher
Patrick Flume

Silhouette
Keywords
Cystic Fibrosis, Lung, Pediatrics, Pulmonary
Summary

This is a research study to find out if a drug called lenabasum can help people with Cystic Fibrosis (CF) and if it is safe to take without causing too many side effects. There are 9 planned study visits in the institution during this study.

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

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL STUDY TO ASSESS THE SAFETY AND EFFICACY OF PULSED, INHALED NITRIC OXIDE (iNO) IN SUBJECTS WITH PULMONARY HYPERTENSION ASSOCIATED WITH PULMONARY FIBROSIS ON LONG TERM OXYGEN THERAPY (PART 1 AND PART 2) Save

Date Added
January 23rd, 2018
PRO Number
Pro00074258
Researcher
Rahul Argula

Silhouette
Keywords
Lung, Pulmonary
Summary

The purpose of this study is to determine if the study drug, inhaled nitric oxide, when given and breathed through an investigational study device called the INOpulse, may help treat PF. Inhaled nitric oxide is a drug approved by the FDA and Health Canada for the treatment of infants who have difficulty breathing and have decreased oxygen in their blood associated with pulmonary hypertension. Inhaled nitric oxide and the INOpulse delivery device are investigational for the treatment of PF with and without pulmonary hypertension and are not currently an approved treatment. Because we do not know if this drug and device combination will treat PF, we need to compare it against a placebo (a pretend drug that has no effect on a person). To do this, we will put people taking part in this study into two groups. The groups are selected by chance, like a coin toss. Participants in one group will be given the study drug while participants in the other group will be given the pretend drug.

Institution
MUSC
Recruitment Contact
Jordyn DeMartino
(843) 792-8092
demartij@musc.edu

The CHEC-SC Cohort Study: CHaractErizing CFTR Modulated Changes in Sweat Chloride and their Association with Clinical Outcomes Save

Date Added
January 10th, 2018
PRO Number
Pro00073414
Researcher
Sylvia Szentpetery

Silhouette
Keywords
Cystic Fibrosis, Lung, Pediatrics, Pulmonary
Summary

This is an observational study which will collect sweat chloride values from approximately 1000 cystic fibrosis subjects who are currently on cystic fibrosis transmembrane conductance regulator (CFTR) modulators. This study will require one visit to an MUSC clinic which will last approximately 2 hours. Compensation is provided.

Institution
MUSC
Recruitment Contact
Abbi Reed
843-792-1820
reedab@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

A Study to Evaluate a Panel of Blood Biomarkers for Use in Patients Undergoing Evaluation for Lung Cancer, ONC-LN-04 Save

Date Added
December 28th, 2017
PRO Number
Pro00061985
Researcher
Nichole Tanner

Silhouette
Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

The primary objective of this study is to develop a blood-based gene expression signature, known as the ONC-LN-04 Lung Test, to be used in the detection of lung cancer in patients who underwent radiologic screening for lung cancer and had lung nodules detected. We intend to enroll volunteers who are being evaluated by a Ralph H. Johnson VAMC pulmonologist as part of their standard medical care. Participants will be current or former smokers, who have either (a) radiologic evidence of lung nodules, or (b) a confirmed diagnosis of non-small cell lung cancer (NSCLC) and has not undergone surgical excision, chemotherapy or radiation therapy for this malignancy. A single blood sample will be obtained from willing participants, then stored and analyzed for measurement of gene expression and development of the ONC-LN-04 test. Active participation in this study will be over once a blood sample is obtained; however, we may need access to participants' medical records post-enrollment and sample collection in order to monitor medical outcomes. Review of participants' medical records will occur until up to approximately 2,500 subjects have been enrolled and have provided clinical information and a blood sample.

Institution
MUSC
Recruitment Contact
Savannah Miller
843-792-9873
millesav@musc.edu

Multicenter, Prospective triAL of ELectromagnetIc BroNchoscOpic and ElectromagNEtic Transthoracic Approaches for the Biopsy of Peripheral Pulmonary Nodules Save

Date Added
December 28th, 2017
PRO Number
Pro00071965
Researcher
Nicholas Pastis

Silhouette
Keywords
Cancer, Lung, Pulmonary
Summary

This is a multi-center, non-randomized, single-arm, prospective trial to evaluate a staged sampling methodology designed to maximize the diagnostic yield of lung biopsy in a single procedure setting. Diagnostic yield will follow biopsy of peripheral pulmonary nodules as identified on chest CT utilizing (1) EMN bronchoscopy, and/or (2) EMN-TTNA.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@musc.edu

A Phase 2, 24-Week Randomized, Double-blind, Placebo-Controlled Multicenter Study, Followed by a 28-Week Treatment Extension, to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Idiopathic Pulmonary Fibrosis Save

Date Added
November 14th, 2017
PRO Number
Pro00070979
Researcher
Timothy Whelan

Silhouette
Keywords
Lung, Pulmonary
Summary

The purpose of this study is to test an experimental drug called CC-90001. This study will test CC-90001 (at doses of either 200 mg or 400 mg, given by mouth, once daily) compared to placebo, an inactive substance that contains no medicine. This study is being conducted to test the effect of CC-90001 on improving your IPF, and to see how well your body tolerates CC-90001.

Institution
MUSC
Recruitment Contact
Tomika Caldwell
(843) 792-3162
caldwet@musc.edu

Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Save

Date Added
October 24th, 2017
PRO Number
Pro00071782
Researcher
Patrick Flume

Silhouette
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

Vertex is offering the EAP (Expanded Access Program) in order to respond to requests from physicians to make TEZ/IVA available for use by Eligible Patients under the supervision of the requesting physician. This program will be available until TEZ/IVA or a suitable alternative treatment has been approved and is funded or reimbursed by an insurance company or a publicly-funded program or agency or by private supplementary health benefits insurance.

Institution
MUSC
Recruitment Contact
Robyn Do
(843) 792-1221
dorobyn@musc.edu

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY OF AEROVANC FOR THE TREATMENT OF PERSISTANT METHICILLIN-RESISTANT Staphylococcus aureus LUNG INFECTION IN CYSTIC FIBROSIS PATIENTS Save

Date Added
October 24th, 2017
PRO Number
Pro00071904
Researcher
Patrick Flume

Silhouette
Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this research study is to evaluate the effectiveness and safety of AeroVanc compared to placebo (an inactive substance) in patients (also called subjects) with CF and a chronic MRSA lung infection.

Institution
MUSC
Recruitment Contact
Julia Palmer
(843) 792-3169
palmerju@musc.edu

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