EUROPT Clinical Trial to Study the Efficacy of One-Way Valve Implantation (New Treatment Algorithm) in Patients With Heterogeneous Emphysema

NCT00730301 | Unknown Phase 4 DMC

• 1 other identifier: EUROPT 07-074-0507
• Study Type: interventional
• Target: 20
• Locations: 2 countries
• Sites: 3

Brief Summary

The purpose of this study is to assess the efficacy of a new treatment algorithm for bronchoscopic lung volume reduction (BLVR) in patients with emphysema based on the information of emphysema heterogeneity, destruction score, and fissure analysis.

Conditions

Emphysema; Chronic Obstructive Pulmonary Disease

Keywords

Emphysema; Chronic obstructive pulmonary disease; Lung volume reduction; Lung function

Outcome Measures

Primary Outcomes (1)

• Mean % change in lung function (FEV1)

  90 days post index bronchoscopic lung volume reduction

Secondary Outcomes (1)

• Mean % change in target lobe Residual Volume and Total Lung Capacity. Mean absolute change in dyspnea (mMRC-Score), Quality of life using St. George's Respiratory Questionnaire and SF-36.

  90 days post-index bronchoscopic lung volume reduction

Interventions

Bronchoscopic Lung Volume Reduction (BLVR) PROCEDURE

Procedure under general anesthesia.

Also known as: ZephyrTM Endobronchial Valve (EBV) (Emphasys Medical, Inc., Redwood City, CA)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient diagnosed by HRCT Core Lab with eligible heterogeneous disease distribution and at least one complete oblique fissure.
• Age from 40 to 75 years
• BMI \< 32 kg/m2
• FEV1 \< 40% of predicted value, FEV1/FVC \< 70%
• TLC \> 120% predicted, RV \> 150% predicted.
• Stable with \< 20 mg prednisone (or equivalent) qd
• PaCO2 \< 50mm Hg
• PaO2 \> 45 mm Hg on room air
• min walk of \> 50m (without rehabilitation) or \> 100m (with rehabilitation)
• Nonsmoking for 4 months prior to initial interview and throughout screening
• The patient agrees to all protocol required follow-up intervals.
• The patient has no child bearing potential
• The patient is willing and able to complete protocol required baseline assessments and procedures

You may not qualify if:

• Prior endobronchial treatment for emphysema
• Pleural or interstitial disease that precludes surgery.
• Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy.
• Clinically significant bronchiectasis
• Pulmonary nodule requiring surgery
• History of recurrent respiratory infections (\> 3 hospitalization in the last year)
• Clinically significant (\> 4 Tablespoons per day) sputum production
• Fever, elevated white cell count, or other evidence of active infection
• Dysrhythmia that might pose a risk during exercise or training
• Congestive heart failure within 6 mo and LVEF \< 45%
• Evidence or history of Cor Pulmonale
• Resting bradycardia (\< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, sustained SVT
• History of exercise-related syncope
• MI within 6 mo and LVEF \< 45%
• Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period

Sponsors & Collaborators

• LudwLudwig Boltzmann Institute for COPD and Respiratory Epidemiology: lead

Study Sites (3)

Otto Wagner Hospital

Vienna, Vienna, 1140, Austria

RECRUITING

University Antwerp

Antwerp, Belgium

RECRUITING

University Brussels

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Arschang Valipour, MD

  Ludwig Boltzmann Institute for COPD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arschang Valipour, MD

CONTACT

+43-1-91060-41833; arschang.valipour@wienkav.at

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 5, 2008
• First Posted: August 8, 2008
• Study Start: July 1, 2007
• Primary Completion: September 1, 2008
• Last Updated: August 8, 2008

Record last verified: 2008-08

Locations

AU (1); BE (2)