Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema

NCT ID: NCT03360396

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-07
• Study Completion Date: 2022-11-22

Brief Summary

This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema.

Detailed Description

This will be a prospective, multicenter, randomized, controlled study comparing outcomes between the Endobronchial Coil and Control Groups. Subjects will be block randomized in a Treatment to Control ratio of 2:1. The randomization will be stratified by site and homogeneous versus heterogeneous emphysema, to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups

Conditions

Emphysema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Endobronchial Coils

Treatment with PneumRx Endobronchial Coil System

Group Type: EXPERIMENTAL

Endobronchial Coils

Intervention Type: DEVICE

Endobronchial Coil implants

Control

Medically-managed control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Endobronchial Coils

Endobronchial Coil implants

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Read, understood and signed the Informed Consent form
• Meets indications for use per the IFU
• Bilateral heterogeneous and/or homogeneous emphysema
• Post bronchodilator 15% predicted ≤ Forced Expiratory Volume in 1 second (FEV1) ≤ 45% predicted
• Post bronchodilator Residual Volume (RV) ≥ 200% predicted
• Post bronchodilator Total Lung Capacity (TLC) >100% pred.
• Post bronchodilator RV/TLC > 55%
• Dyspnea related to hyperinflation scored ≥ 2 on modified Medical Research Council (mMRC) dyspnea scale despite optimal medical management
• Receiving optimal drug therapy and medical management according to clinical practice.
• Performing regular physical activity, at least 2 times per week
• Stopped smoking as confirmed by carboxyhemoglobin (CoHB)
• 100m ≤ 6 minute walk distance (6MWD) ≤ 450m
• Deemed eligible per Eligibility Review Committee (ERC)
• if treated in France, subject must be entitled to French social security.

Exclusion Criteria

• Known sensitivity to drugs required for performing bronchoscopy or in whom bronchoscopic procedures are contraindicated
• Evidence of active infection in the lungs
• Hypersensitivity or allergy to nitinol (nickel-titanium) or its constituent metals
• Clinical significant pulmonary fibrosis
• Clinically significant, generalized bronchiectasis
• Clinically significant bleeding disorders
• Patient taking immunosuppressive drugs other than steroids (e.g., for the treatment of cancer, rheumatoid arthritis, autoimmune disease, or prevention of tissue or organ rejection).
• Primary diagnosis of asthma
• Two (2) or more COPD exacerbations in the prior year, or 1 or more COPD exacerbations in the prior 3 months with indication for hospitalization assessment, according to GOLD 2017 recommendations .
• Predominant small airways disease defined as significant bronchiectasis with sputum production (> 2 tablespoons daily) or significant bronchial wall thickening per High Resolution Computed Tomography (HRCT)
• Percent Low Attenuation Area (%LAA) < 20% in the most damaged lobe of either lung.
• Computed Tomography (CT) Imaging consistent with active pulmonary infection, significant interstitial disease or pleural disease
• Severe bullous disease (defined by bulla > 8cm or 1/3 of lung volume, or single bullous defect >8 cm) or predominant paraseptal emphysema [defined by numerous large (>1cm) paraseptal defects in the target lobe comprising of >5% of total lung volume].
• Lung pathology of nodule not proven stable or benign
• Radiographic confirmation of atelectasis or other scarring/fibrosis in areas of intended Coil implant
• Use of more than 20 mg/day prednisolone or equivalent dosage of a different corticosteroid
• Severe pulmonary hypertension (Right Ventricular Systolic Pressure (RVSP) > 50 mm Hg or other signs of Pulmonary Hypertension (PHT) with right ventricular dysfunction)
• Severe hypercapnia (PaCO2 > 55 mmHg on room air) and/or severe hypoxemia (PaO2 < 45mm Hg on room air, High altitude criterion: PaO2 < 30 mm Hg)
• Previous Lung Volume Reduction (LVR) surgery, lung transplantation, lobectomy, LVR devices or other device to treat COPD in either lung.
• Diagnosed with alpha-1 antitrypsin deficiency
• Diffusion Capacity of the lungs for Carbon Monoxide (DLCO) < 20 %
• Significant, recent or unstable cardiac disease defined as severe heart failure (Left Ventricular Ejection Fraction (LVEF) < 45% despite optimal medical management), unstable cardiac arrhythmia or coronary artery disease (angina on activity), or ischemic event in the past 6 months.
• Body Mass Index (BMI) > 30
• Participation in any other clinical Study.
• Subject is pregnant or lactating, or plan to become pregnant within the study timeframe.
• If treated in France, Subject is a "personnel vulnerable" as defined by French Regulation

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PneumRx, Inc.

INDUSTRY

Sponsor Role: collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Felix Herth, MD,

Role: PRINCIPAL_INVESTIGATOR

University Hospital Heidelberg

Arschang Valipour, MD,FCCP,PhD

Role: PRINCIPAL_INVESTIGATOR

Nord-Klinik Floridsdorf

Locations

Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie

Vienna, , Austria

CHU Grenoble

Grenoble, , France

CHU Montpellier

Montpellier, , France

Centre Hospitalier Universitaire de Nice

Nice, , France

Hôpital Bichat

Paris, , France

CHU de Reims - Hopital Maison Blanche

Reims, , France

Nouvel Hôpital Civil

Strasbourg, , France

Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie

Berlin, , Germany

Gemeinschaftskrankenhaus Havelhöhe GmbH

Berlin, , Germany

Universitätsklinkum Bonn

Bonn, , Germany

Ruhrlandklinik Essen

Essen, , Germany

Thoraxklinik

Heidelberg, , Germany

Lungenklinik

Hemer, , Germany

Lungenfachklinik Immenhausen

Immenhausen, , Germany

Klinikverbund Kempten-Oberallgäu

Immenstädt, , Germany

Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH

Stuttgart, , Germany

Ospedale Careggi

Florence, , Italy

University Medical Center Groningen

Groningen, , Netherlands

Royal Brompton Hospital

London, , United Kingdom

Countries

Austria; France; Germany; Italy; Netherlands; United Kingdom

References

Agrawal A. Interventional Pulmonology: Diagnostic and Therapeutic Advances in Bronchoscopy. Am J Ther. 2021 Feb 9;28(2):e204-e216. doi: 10.1097/MJT.0000000000001344.

Reference Type: DERIVED

PMID: 33590989 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BTG-004517-01

Identifier Type: -

Identifier Source: org_study_id