Trial record 1 of 5 for:    "IMPACT" and "Zephyr"
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Improving Patient Outcomes by Selective Implantation of the Zephyr EBV - Study (IMPACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02025205
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : October 11, 2017
Information provided by (Responsible Party):
Pulmonx, Inc. ( Pulmonx International Sàrl )

Brief Summary:
The aim of this prospective, randomized, controlled, one-way crossover study is to assess and compare the efficacy of the Zephyr endobronchial valves vs. Standard of Care (SoC) in patients suffering from COPD with Homogeneous Emphysema. Patients will be followed up for 12 months after randomization. Patients in the SoC arm will crossover to the EBV treatment arm after the 6-month visit and will be followed up for 6 additional months.The primary objective is the variation of FEV1 between baseline and 3-month follow-up visit. The secondary objectives will evaluate quality of life, exercise capacity, dyspnea (including BODE index) changes, target lobe volume reduction, as well as safety outcomes.

Condition or disease Intervention/treatment Phase
COPD Patients With Homogeneous Emphysema Endoscopic Lung Volume Reduction With Endobronchial Valve Device: Endobronchial Valve Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicentre, Prospective, Randomized, Controlled, One-way Crossover Investigation of Endobronchial Valve (EBV) Therapy vs. Standard of Care (SoC) in Homogeneous Emphysema
Actual Study Start Date : August 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : March 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arm Intervention/treatment
Experimental: ELVR with Endobronchial Valves
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
Device: Endobronchial Valve
Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve

No Intervention: Standard of Care
Patients will receive optimal drug therapy and medical management according to clinical practice.

Primary Outcome Measures :
  1. Percentage change in Forced Expiratory Volume in 1 s (FEV1) [ Time Frame: At baseline and after 3 months ]

Secondary Outcome Measures :
  1. Change in Quality of life (FEV1, SGRQ, CAT, EQ-5D) [ Time Frame: At baseline and after 3, 6 and 12 months ]
  2. Change in Exercise Capacity (6-MWT) [ Time Frame: At baseline and after 3 and 6 months ]
  3. Change in Dyspnea (mMRC) [ Time Frame: At baseline and after 3 and 6 months ]
  4. Adverse Events and Serious Adverse Events [ Time Frame: At each visits ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Homogeneous emphysema
  • 15% < or = FEV1 < or = 45% predicted
  • TLC > 100% predicted
  • RV > or = 200% predicted
  • 6-MWT > or = 150 m
  • Non-smoker > 8 weeks prior to study entry
  • Absence of Collateral Ventilation in the target lobe

Exclusion Criteria:

  • Active pulmonary infection
  • More than 3 exacerbations with hospitalizations over the past 12 months
  • Pulmonary hypertension (sPAP > 45 mmHg)
  • MI or other relevant CV events in the past 6 months
  • Alpha-1 antitrypsin deficiency
  • Bronchiectasis
  • Prior LVR or LVRS procedure
  • > 20% difference in perfusion between right and left lung
  • Hypercapnia (paCO2 > 55 mmHg
  • Asthma
  • Use of more than 25 mg/day prednisolone or equivalent
  • Severe bullous emphysema
  • Systemic or malignant disease with high death probability within 12 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02025205

Ludwig-Boltzmann-Institut für COPD und Pneumologische Epidemiologie
Vienna, Austria, 1140
Charité Campus Virchow-Klinikum
Berlin, Germany, 13353
Ruhrlandklinik, Westdeutsches Lungenzentrum
Essen, Germany, 45239
Lungenabteilung Thoraxzentrum Hamburg
Hamburg, Germany, 21075
Thoraxklinik am Universitäts klinikum Heidelberg
Heidelberg, Germany, 69126
Lungenklinik Hemer
Hemer, Germany, 58675
Klinikum Nürnberg Nord
Nürnberg, Germany, 90419
Department of pulmonary dieases, University Medical Center
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
Pulmonx International Sàrl
Principal Investigator: Arschang Valipour, MD, PhD, FCCP Ludwig-Boltzmann-Institute for COPD and Respiratory Epidemiology Otto-Wagner-Spital 1140 Wien / Austria

Responsible Party: Pulmonx International Sàrl Identifier: NCT02025205     History of Changes
Other Study ID Numbers: 630-0014
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

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