To Improve Lung Function and Symptoms for Emphysema Patients Using Zephyr Valves

NCT02022683 | Completed

• 1 other identifier: 630-0015/A
• Study Type: interventional
• Target: 97
• Locations: 6 countries
• Sites: 17

Brief Summary

To compare the clinical outcomes of Endoscopic Lung Volume Reduction (ELVR) using Pulmonx Zephyr Valves vs. Standard of Care (SoC) in the treatment of heterogeneous emphysema subjects in a controlled trial design setting.

Conditions

COPD; Heterogeneous Emphysema

Keywords

Endoscopic lung volume reduction; Endobronchial valves

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume in 1-second (FEV1) - Responders

  The percentage of trial participants in the EBV treatment arm meeting the minimally clinically important difference (MCID) of \>12% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the control arm at 3 months post-procedure.

  Between baseline and 3 months

Secondary Outcomes (13)

• St George's Respiratory Questionnaire (SGRQ) - Absolute change

  Between Baseline and 3, 6, 12, 18 and 24 months

• St George's Respiratory Questionnaire (SGRQ) - Percent change

  Between Baseline and 3, 6, 12, 18 and 24 months

• St George's Respiratory Questionnaire (SGRQ) - Responders

  Between Baseline and 3, 6, 12, 18 and 24 months

• 6-minute walk distance (6MWT) - Absolute change

  Between Baseline and 3, 6, 12, 18, 24 months

• 6-minute walk distance (6MWT) - Percent change

  Between Baseline and 3, 6, 12, 18, 24 months

Other Outcomes (8)

• Adverse Events

  Between baseline and 24 months

• PaO2 - Absolute change

  Between baseline and 3 months

• PaO2 - Percent change

  Between baseline and 3 months

Study Arms (2)

Endoscopic Lung Volume Reduction

EXPERIMENTAL

Patients are implanted with Zephyr Valves

Device: ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves

Standard of Care

NO INTERVENTION

Patients are given Standard Medical Care

Interventions

ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves DEVICE

Endoscopic Lung Volume Reduction

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obtained informed consent.
• Diagnosis of heterogeneous emphysema with a heterogeneity index of ≥10 % between target and adjacent lobes.
• Subjects of both genders of at least 40 years of age.
• % predicted ≤ FEV1≤ 45% predicted.
• TLC \> 100% and RV ≥ 180% predicted.
• meters \< 6MWD \< 450 meters.
• Non-smoker \>8 weeks prior to signing the Informed Consent.
• CV negative target lobe.
• \- If treated in France, Subject must be entitled to French social security

You may not qualify if:

• Any contraindication for bronchoscopic procedure.
• Evidence of active pulmonary infection.
• History of 2 or more exacerbations requiring hospitalization over the past 12 months.
• Known pulmonary hypertension that according to the physician will be unsuitable for EBV treatment.
• Myocardial infarction or other relevant cardiovascular events in the past 6 months.
• Significant bronchiectasis seen at CT scan.
• Greater than two tablespoons of sputum production per day.
• Prior LVR or LVRS procedure. Criterion 8 French CIP wording\*: Prior lung transplant, median sternotomy, LVR or LVRS procedure (including lobectomy).
• Pulmonary nodule requiring follow-up within any lobe.
• Pregnant or nursing women. French CIP wording\*: Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
• Hypercapnia (paCO2 \> 7.33 kPa).
• Current diagnosis of asthma.
• \> 25mg Prednisolon (or equivalent) use/days.
• Any other condition that as judged by the investigator may make follow-up or investigations inappropriate.
• Evidence of pleural adhesions or earlier pulmonary surgery.

Sponsors & Collaborators

• Pulmonx Corporation: lead

Study Sites (17)

Universiteit Gent

Ghent, 9000, Belgium

Location

AZ Delta

Menen, 8930, Belgium

Location

CHU

Grenoble, 38043, France

Location

CHU Hôpital Pasteur

Nice, 06002, France

Location

Groupe Hospitalier Pitié Salpétrière

Paris, 75013, France

Location

Hôpital Bichat Claude Bernard

Paris, 75877, France

Location

Charité Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Ruhrlandklinik Westdeutsches Lungenzentrum

Essen, 45239, Germany

Location

Thoraxklinik am Universitäts Klinikum Heidelberg

Heidelberg, 69126, Germany

Location

University Medical Center Groningen

Groningen, 9700, Netherlands

Location

Skane University Hospital

Lund, 221 85, Sweden

Location

Uppsala University Hospital

Uppsala, 751 85, Sweden

Location

Sherwood Forest Hospitals NHS

Sutton in Ashfield, Nottinghamshire, NG17 4JL, United Kingdom

Location

West of Scotland Regional Heart & Lung Centre - Golden Jubilee National Hospital

Clydebank, West Dunbartonshire Scotland, G81 4DY, United Kingdom

Location

University Hospital of Wales

Cardiff, CF144XW, United Kingdom

Location

The Royal Brompton Hospital & Harefield NHS Foundation Trust

London, SW3 6NP, United Kingdom

Location

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S5 7AU, United Kingdom

Location

Related Publications (2)

• Bakker JT, Hartman JE, Klooster K, Charbonnier JP, Tsiaousis M, Vliegenthart R, Slebos DJ. Endobronchial valve treatment improves chest-CT diaphragm configuration in COPD. Respir Med. 2024 Nov-Dec;234:107856. doi: 10.1016/j.rmed.2024.107856. Epub 2024 Nov 6.

  PMID: 39515624 DERIVED

• Kemp SV, Slebos DJ, Kirk A, Kornaszewska M, Carron K, Ek L, Broman G, Hillerdal G, Mal H, Pison C, Briault A, Downer N, Darwiche K, Rao J, Hubner RH, Ruwwe-Glosenkamp C, Trosini-Desert V, Eberhardt R, Herth FJ, Derom E, Malfait T, Shah PL, Garner JL, Ten Hacken NH, Fallouh H, Leroy S, Marquette CH; TRANSFORM Study Team *. A Multicenter Randomized Controlled Trial of Zephyr Endobronchial Valve Treatment in Heterogeneous Emphysema (TRANSFORM). Am J Respir Crit Care Med. 2017 Dec 15;196(12):1535-1543. doi: 10.1164/rccm.201707-1327OC.

  PMID: 28885054 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Gunnar Hillerdal, MD, PhD

  Uppsala University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2013
• First Posted: December 30, 2013
• Study Start: January 28, 2014
• Primary Completion: January 20, 2017
• Study Completion: September 27, 2018
• Last Updated: July 2, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); FR (4); BE (2); NL (1); SE (2); GB (5)