Chronic Obstructive Pulmonary Disease (COPD)

Enrollment by Invitation Only:

LVRC IDE Crossover Study

(Crossover from RENEW: Lung Volume Reduction Coil Treatment in Patients with Emphysema Study, IDE G110066)

 This is a multi-center, crossover study for the control group from the RENEW study. All patients who did not get the lung coils implanted will receive the coils in this study.

This research study focuses on determining the following:

1) Whether the Coil application is safe

2) Whether patients’ ability to exercise improves after receiving the Coil

3) Whether patients feel better after receiving the Coil device

4) Whether lung function improves after patients receive the Coil device.

Patients will be followed for safety for five years after coil implantation.

Principal Investigator: Michael Jantz, MD

If you would like more information, please contact Jesse West, RN at 1-352-273-8666.

Clinicaltrials.gov link: https://clinicaltrials.gov/ct2/results?term=LVRC+crossover&Search=Search

Closed to Enrollment:

RENEW: Lung Volume Reduction Coil Treatment in patients with Emphysema (RENEW) Study.

This is a multi-center, randomized, assessor blinded controlled study of the safety and effectiveness of the PneumRx Lung Volume Reduction Coil System. Half of the patients will not receive the Coils (Control Group). All participants will continue to receive Standard Medical Care and followed by Study Staff for 12 months. The study will evaluate device safety and whether participants treated with coils achieve better outcomes.

Principal Investigator: Michael Jantz, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01608490?term=RENEW&rank=1

If you would like more information, please contact Jesse West, RN at 1-352-273-8666.

Closed:

A 52-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)

This study aims to demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.

Principal Investigator:  Mark Brantly, MD

Clinicaltrials.gov link: http://clinicaltrials.gov/ct2/show/NCT01443845?term=COPD+roflumilast&rank=1

If you would like more information, please contact Christina Eagan, RN,  at 352-273-8990.