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

Randomized Controlled Trial Of RePneu (LVRC) Endobronchial Coils For The Treatment Of Severe Emphysema With Hyperinflation (RESET Study)

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.

Study Overview

• Status: Completed
• Conditions: Emphysema
• Intervention / Treatment: Device: Lung Volume Reduction Coil (LVRC) (PneumRx); Device: Control

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
  • London, United Kingdom
    • Chelsea and Westminster Hospital
  • Manchester, United Kingdom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 33 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lung Volume Reduction Coil (LVRC)	Device: Lung Volume Reduction Coil (LVRC) (PneumRx); Lung Volume Reduction Coil (LVRC); Other Names: LVRD
Placebo Comparator: Control; Standard of Care	Device: Control; Standard of Care; Other Names: LVRC Control treatment is Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
St. George's Respiratory Questionnaire (SGRQ)	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.	three month Follow-Up Visit

Collaborators and Investigators

• Sponsor: Boston Scientific Corporation
• Collaborators: PneumRx, Inc.
• Investigators: Principal Investigator: Pallav Shah, MD, Chelsea and Westminster Hospital

Publications and helpful links

General Publications

• Zoumot Z, Kemp SV, Singh S, Bicknell SR, McNulty WH, Hopkinson NS, Ross ET, Shah PL. Endobronchial coils for severe emphysema are effective up to 12 months following treatment: medium term and cross-over results from a randomised controlled trial. PLoS One. 2015 Apr 8;10(4):e0122656. doi: 10.1371/journal.pone.0122656. eCollection 2015.
• Shah PL, Zoumot Z, Singh S, Bicknell SR, Ross ET, Quiring J, Hopkinson NS, Kemp SV; RESET trial Study Group. Endobronchial coils for the treatment of severe emphysema with hyperinflation (RESET): a randomised controlled trial. Lancet Respir Med. 2013 May;1(3):233-40. doi: 10.1016/S2213-2600(13)70047-X. Epub 2013 Apr 23.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: April 1, 2011
• First Submitted That Met QC Criteria: April 11, 2011
• First Posted (Estimate): April 13, 2011

Study Record Updates

• Last Update Posted (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 15, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Emphysema; RePneu
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: CLN0008