Randomized Comparison of the RePneu Lung Volume Reduction Coil (LVRC) to Standard of Care for the Treatment of Emphysema (RESET Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PneumRx, Inc.
ClinicalTrials.gov Identifier:
NCT01334307
First received: April 1, 2011
Last updated: January 22, 2014
Last verified: May 2012
  Purpose

The objective of this study is to demonstrate the safety and performance of the PneumRx, Inc. Lung Volume Reduction Coil (LVRC) in a population of patients with emphysema. The PneumRx, Inc. LVRC is used as a less invasive alternative to lung volume reduction surgery.


Condition Intervention Phase
Emphysema
Device: Lung Volume Reduction Coil (LVRC) (PneumRx)
Device: Control
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)

Resource links provided by NLM:


Further study details as provided by PneumRx, Inc.:

Primary Outcome Measures:
  • St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: three month Follow-Up Visit ] [ Designated as safety issue: No ]
    The primary efficacy endpoint will be the difference between treatment and control groups in the change in St. George's Respiratory Questionnaire (SGRQ) from Baseline (Pre-Treatment Visit) to the three month Follow-Up Visit.


Enrollment: 47
Study Start Date: February 2010
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lung Volume Reduction Coil (LVRC)
Lung Volume Reduction Coil (LVRC)
Device: Lung Volume Reduction Coil (LVRC) (PneumRx)
Lung Volume Reduction Coil (LVRC)
Other Name: LVRD
Placebo Comparator: Control
Standard of Care
Device: Control
Standard of Care
Other Name: LVRC Control treatment is Standard of Care

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient greater than or equal to 35 years of age
  • High resolution CT scan indicates unilateral or bilateral emphysema
  • High resolution CT scan indicates homogeneous or heterogeneous emphysema
  • Patient has post-bronchodilator FEV1 less than or equal to 45% predicted
  • Total Lung Capacity greater than 100% predicted
  • Patient has marked dyspnea scoring greater than or equal to 2 on mMRC scale of 0-4
  • Patient has stopped smoking for a minimum of 8 weeks prior to entering the study
  • Patient (and legal guardian if applicable) read, understood and signed the Informed Consent form

Exclusion Criteria:

  • Patient has a change in FEV1 greater than 20% post-bronchodilator
  • Patients DLCO less than 20% predicted
  • Patient has a history of recurrent clinically significant respiratory infection
  • Patient has uncontrolled pulmonary hypertension defined by right ventricular pressure greater than 50mm Hg and/or evidenced by echocardiogram
  • Patient has an inability to walk greater than 140 meters (150 yards) in 6 minutes
  • Patient has evidence of other disease that may compromise survival such as lung cancer, renal failure, etc
  • Patient is pregnant or lactating
  • Patient has an inability to tolerate bronchoscopy under heavy sedation or anesthesia
  • Patient has clinically significant bronchiectasis
  • Patient has giant bullae greater than 1/3 lung volume
  • Patient has had previous LVR surgery, lung transplant or lobectomy
  • Patient has been involved in other pulmonary drug studies with 30 days prior to this study
  • Patient is taking greater than 20 mg prednisone (or similar steroid) daily
  • Patient is on Plavix or has not been weaned off prior to procedure
  • Patient has other disease that would interfere with completion of study, follow up assessments or that would adversely affect outcomes
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334307

Locations
United Kingdom
Glasgow, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
PneumRx, Inc.
Investigators
Principal Investigator: Pallav Shah, MD Chelsea and Westminster Hospital
  More Information

No publications provided by PneumRx, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PneumRx, Inc.
ClinicalTrials.gov Identifier: NCT01334307     History of Changes
Other Study ID Numbers: CLN0008
Study First Received: April 1, 2011
Last Updated: January 22, 2014
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by PneumRx, Inc.:
Emphysema
RePneu

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014