Clinical trial NCT00129584: Endobronchial Valve for Emphysema Palliation Trial (VENT)
Official title: Endobronchial Valve for Emphysema Palliation Trial (VENT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Emphysema
Keywords: Endobronchial Valve (EBV) Procedure
Bronchoscopic Lung Volume Reduction
Lead sponsor: Emphasys Medical
Sponsor class: INDUSTRY
First posted: 2005-08-12
Enrollment: 270
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to optimal medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.

Detailed description: Background:

Emphysema, caused primarily by smoking, is characterized by the gradual, irreversible breakdown of tissue and loss of elastic recoil within the lungs, causing them to lose the ability to expel air and efficiently absorb oxygen. As this chronic condition inexorably progresses, the diseased, hyperinflated areas of the lung eventually fill the chest cavity, leaving less and less volume available for the viable lung tissue.

Lung volume reduction surgery (LVRS) has been shown to offer relief to patients suffering from emphysema when other treatment options fail. Researchers have continued to refine both technique and patient selection in order to improve outcomes. The objective of lung volume reduction is to eliminate dysfunctional, over-inflated regions of lung. Results similar to surgical removal have been obtained by plication (folding) and stapling without tissue removal. These results suggest that isolation of the dysfunctional lung region can achieve similar results to tissue removal.

The paradoxical effect of improving lung function by removing (or isolating) lung tissue demonstrates that breathlessness due to emphysema is a function of mechanical inefficiencies in addition to loss of gas-transfer surface area and other physiological mechanisms. At least in some patients, the mechanical compromise is the primary cause of their pulmonary incapacitation and these patients can benefit by addressing their inability to effectively inhale and exhale. Because LVRS reduces trapped gas, others have speculated that results similar to LVRS could be achieved bronchoscopically by reducing the volume of the hyperinflated regions with, or without, atelectasis.

Emphasys has developed a bronchoscopic approach to block inspiratory airflow into targeted, hyperinflated regions of the lung, while permitting exhaled gas to escape. This approach may lead to lung volume reduction and provide some of the clinical benefits of LVRS without the high risks and costs associated with such an invasive surgical procedure.

Comparison:

The primary object of this study is to assess the safety and efficacy of the Emphasys Endobronchial Valve (EBV) and procedure (with pulmonary rehabilitation) compared to medical management (with pulmonary rehabilitation) in patients with heterogeneous emphysema.

Eligibility criteria: Inclusion Criteria:

* Diagnosed by high-resolution computed tomography (HRCT) with eligible heterogeneous disease distribution
* Forced expiratory volume in 1 second (FEV1) \< 45% predicted
* Total lung capacity (TLC) \> 100% predicted
* Residual volume (RV) \> 150% predicted
* Post rehabilitation 6 minute walk test \> 140m
* Non-smoking for 4 months

Exclusion Criteria:

* Prior lung transplant, LVRS, median sternotomy, bullectomy or lobectomy
* History of recurrent respiratory infections
* Evidence of large bullae (\>30% of either lung) in a non-target lobe
* FEV1 \< 15% predicted
* Diffusing capacity for carbon monoxide (DLCO) \< 20% predicted

Primary outcomes:
measure: Pulmonary function testing at various time points through one year
measure: Exercise tolerance at various time points through one year
measure: Major complications at various time points through one year
Secondary outcomes:
measure: Pulmonary function testing at various time points through one year
measure: Quality of life measures at various time points through one year
measure: Other adverse event rates at various time points through one year
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Frank C Sciurba, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Valipour A, Herth FJ, Burghuber OC, Criner G, Vergnon JM, Goldin J, Sciurba F, Ernst A; VENT Study Group. Target lobe volume reduction and COPD outcome measures after endobronchial valve therapy. Eur Respir J. 2014 Feb;43(2):387-96. doi: 10.1183/09031936.00133012. Epub 2013 Jul 11.
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