Clinical trial NCT03360396: Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema
Official title: A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emphysema
Keywords: severe heterogeneous emphysema
severe homogeneous emphysema
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: PneumRx, Inc.
First posted: 2017-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Percent Change in FEV1 at 6 Months
timeFrame: 6 months
measure: Absolute Change in SGRQ Score at 6 Months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Ludwig Boltzmann Institut Fur COPD und pneumologische Epidemologie
city: Grenoble
country: France
facility: CHU Grenoble
city: Montpellier
country: France
facility: CHU Montpellier
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice
city: Paris
country: France
facility: Hôpital Bichat
city: Reims
country: France
facility: CHU de Reims - Hopital Maison Blanche
city: Strasbourg
country: France
facility: Nouvel Hôpital Civil
city: Berlin
country: Germany
facility: Charite Berlin - Medizinische Klinik mit Schwerpunkt Infektiologie und Pneumologie
city: Berlin
country: Germany
facility: Gemeinschaftskrankenhaus Havelhöhe GmbH
city: Bonn
country: Germany
facility: Universitätsklinkum Bonn
city: Essen
country: Germany
facility: Ruhrlandklinik Essen
city: Heidelberg
country: Germany
facility: Thoraxklinik
city: Hemer
country: Germany
facility: Lungenklinik
city: Immenhausen
country: Germany
facility: Lungenfachklinik Immenhausen
city: Immenstädt
country: Germany
facility: Klinikverbund Kempten-Oberallgäu
city: Stuttgart
country: Germany
facility: Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
city: Firenze
country: Italy
facility: Ospedale Careggi
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: University Hospital Heidelberg
name: Felix Herth, MD,
role: PRINCIPAL_INVESTIGATOR
affiliation: Nord-Klinik Floridsdorf
name: Arschang Valipour, MD,FCCP,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.