Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study

Lung Volume Reduction Coil for Treatment in Patients With Emphysema (RENEW) Study



Sponsors

Lead Sponsor



Source

PneumRx, Inc.

Oversight Info

Authority

United States: Food and Drug Administration

Has Dmc

Yes


Brief Summary

Multicenter, randomized, assessor-blinded controlled study of safety and effectiveness of
the PneumRx, Inc. RePneu Lung Volume Reduction Coil (RePneu LVRC) System

Overall Status

Recruiting

Start Date

2012-10-01

Completion Date

N/A

Primary Completion Date

2014-09-01

Phase

Phase 3

Study Type

Interventional

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary Outcome

Measure

Time Frame

Safety Issue

mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups
baseline through 12 months follow up
No

Secondary Outcome

Measure

Time Frame

Safety Issue

St. George's Respiratory Questionnaire (SGRQ)
BL to 12 months
No

Enrollment

315

Condition


Intervention

Intervention Type

Device

Intervention Name


Description

The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

Arm Group Label

RePneu Lung Volume Reduction Coil (RePneu LVRC) System


Eligibility

Criteria

Inclusion Criteria:

- Subject is greater than or equal to 35 yrs of age

- CT Scan indicates bilateral emphysema

- Subject has post-bronchodilator FEV1 less than or equal to 45% predicted

- Subject has Total Lung Capacity >100% predicted

- Subject has residual volume (RV) greater than or equal to 225%

- Subject has marked dyspnea greater than or equal to 2 on mMRC scale of 0-4

- Subject has stopped smoking for at least 8 wks prior to entering the study,
confirmed by cotinine level of less than 10ng/mL.

- Subject has completed a pulmonary rehabilitation program within 6 mos prior to
treatment and/or is regularly performing maintenance respiratory rehabilitation if
initial supervised therapy occurred more than 6 mos prior to baseline testing.

- Subject has received Pneumococcal and Influenza vaccinations consistent with local
recommendations and/or policy.

- Subject (and legal guardian, if applicable) has read, understood, and signed the
Informed Consent form.

Exclusion Criteria:

- Subject has severe homogeneous emphysema determined by Core Radiology Lab.

- Subject has co-morbidities that may significantly reduce subject's ability to improve
exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline
limitation on 6MWT is not due to dyspnea.

- Subject has a change in FEV1 of greater than 20% (or, for subjects with
pre-bronchodilator FEV1 below 1L, a change of greater than 200mL)
post-bronchodilator.

- Subject has DLCO of less than 20% of predicted.

- Subject has severe gas exchange abnormalities, PaCO2 of greater than 55mm Hg; PaO2 of
less than 45 mm Hg on room air (high altitude criterion: PaO2 of less than 30mm Hg).

- Subject has a history of recurrent clinically significant respiratory infections,
defined as 3 hospitalizations for respiratory infection during the year prior to
enrollment.

- Subject as severe pulmonary hypertension defined by right ventricular systolic
pressure of greater than 50mm Hg and/or echocardiogram

- Subject has an inability to walk >140m (150 yd) in 6 minutes

- Subject has evidence of other severe disease (such as but not limited to lung cancer
or renal failure), which in the judgment of the investigator may compromise survival
of the subject for the duration of the study.

- Subject is pregnant or lactating, or plans to become pregnant within the study
timeframe.

- Subject has an inability to tolerate bronchoscopy under moderate sedation or general
anesthesia.

- Subject has clinically significant bronchiectasis.

- Subject has giant bullae >1/3 lung volume

- Subject has had previous LVR surgery, lung transplantation, lobectomy or LVR devices
in either lung.

- Subject has been involved in pulmonary drug or device studies within 30 days prior to
this study.

- Subject is taking >20mg prednisone (or equivalent dose of a similar steroid) daily.

- Subject requires high level chronic immunomodulatory therapy to treat a moderate to
severe chronic inflammatory autoimmune disorder.

- Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such
as Heparin or Coumadin) which cannot be stopped for 7 days prior to the procedure.

- Subject has any other disease, condition(s) or habit(s) that would interfere with
completion of study and follow up assessments, would increase risks of bronchoscopy
or assessments, or in the judgment of the investigator would potentially interfere
with compliance to this study or would adversely affect study outcomes.

- Subject has a sensitivity or allergy to Nickel.

- Subject has a known sensitivity to drugs required to perform bronchoscopy.

- Subject has been diagnosed with alpha-1 antitrypsin deficiency (AATD).

Gender

Both

Minimum Age

35 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Charlie Strange, MD
Principal Investigator
Medical University of South Carolina

Location

Facility

Status

Contact

Investigator

Northwestern University
Chicago Illinois 60611 United States
Recruiting
Last Name: Danielle Barkema, MS
Phone: 312-695-4828
Email: d-barkema@northwestern.edu
Last Name: Ravi Kalhan, MD
Role: Principal Investigator
Beth Israel Deaconess Medical Center
Boston Massachusetts 02215 United States
Recruiting
Last Name: Erin D. Archard
Phone: 617-632-8386
Email: earchard@caregroup.org
Last Name: Adnan Majid, MD, FCCP
Role: Principal Investigator

Last Name: Erik Folch
Role: Sub-Investigator

Duke University Medical Center
Durham North Carolina 27710 United States
Not yet recruiting
Last Name: Emily Smathers, MPH
Phone: 919-668-3812
Email: emily.smathers@duke.edu
Last Name: Momen M Wahidi, MD, MBA
Role: Principal Investigator
Temple
Philadelphia Pennsylvania 19140 United States
Recruiting
Last Name: Jinal Gangar, MBBS, MPH
Phone: 215-707-2291
Email: Jinal.Gangar@tuhs.temple.edu
Last Name: Gerard Criner, MD, FACP, FACCP
Role: Principal Investigator
Emphysema COPD Research Center, University of Pittsburgh
Pittsburgh Pennsylvania 15213 United States
Recruiting
Last Name: Christina Ledezma, PhD
Phone: 412-864-3368
Email: ledezmacm@upmc.edu
Last Name: Frank C. Sciurba, MD
Role: Principal Investigator
Medical University of South Carolina
Charleston South Carolina 29425-6300 United States
Not yet recruiting
Last Name: Laura Bailey
Phone: 843-792-2072
Email: baileyll@musc.edu
Last Name: Charlie Strange, MD
Role: Principal Investigator
DeBakey Medical Center - VA Houston
Houston Texas 77030 United States
Active, not recruiting
Pulmonary, Critical Care & Sleep Medicine Consultants,PCCS/St. Luke's Episcopal Hospital
Houston Texas United States
Not yet recruiting
Last Name: RaLisa Parham
Phone: 713-255-4000
Email: rparham@houstonlungdocs.com
Last Name: Timothy A Connolly, MD, FCCP, DABSM
Role: Principal Investigator
University of Texas Health Sciences Center at San Antonio
San Antonio Texas 78229-3900 United States
Not yet recruiting
Last Name: Luis F Angel, MD
Role: Principal Investigator
University of Wisconsin School of Medicine & Public Health
Madison Wisconsin 53792 United States
Not yet recruiting
Last Name: Scott Ferguson, MD
Role: Principal Investigator
University Medical Center Groningen
Groningen 9713 GZ Netherlands
Recruiting
Last Name: Karin Klooster
Email: k.klooster@int.umcg.nl
Last Name: Dirk-Jan Slebos, MD
Role: Principal Investigator
Royal Brompton Hospital & Chelsea Westminster
London SW3 6NP United Kingdom
Recruiting
Last Name: Zaid Zoumot, MD
Email: zzoumot@doctors.org.uk
Last Name: Pallav Shah, MD
Role: Principal Investigator

Location Countries

Country

United States

Netherlands

United Kingdom



Verification Date

2012-12-01

Lastchanged Date

2013-01-05

Firstreceived Date

2012-05-26

Responsible Party

Responsible Party Type

Sponsor


Keyword


Is Fda Regulated

Yes

Has Expanded Access

No

Condition Browse


Number Of Arms

2

Is Section 801

Yes

Arm Group

Arm Group Label

RePneu Lung Volume Reduction Coil (RePneu LVRC) System

Arm Group Type

Experimental


Arm Group Label

Control arm to receive standard medical care as LVRC

Arm Group Type

No Intervention

Description

The Control Group will receive all the same standard medical treatment as the Treatment Group, except they will not undergo any bronchoscopies for Coil placement during the IDE study and will not receive prophylactic antibiotics or steroids before and after 'treatment' nor will these subjects receive chest x-rays in connection with the 'treatment' visits. However, the frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.



Firstreceived Results Date

N/A

Acronym

RENEW


Information obtained from ClinicalTrials.gov on January 21, 2013

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2014 ICH GCP