Exhale (R) Stent for Emphysema

NCT00207337 | Completed Phase 2

• 1 other identifier: 0304-28
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 6

Brief Summary

Current treatment for emphysema is limited to measures that include inhaled oxygen, bronchodilators, anti-inflammatory drugs and pulmonary rehabilitation. Highly invasive procedures such as lung volume reduction surgery or lung transplantation are also performed. Treatment using the Exhale Drug-Eluting Stent (DES) is a minimally invasive bronchoscopic treatment that has the potential to reduce shortness of breath in emphysema patients. This study tests the safety and effects of Exhale DES in the treatment of patients with emphysema.

Conditions

Emphysema

Keywords

COPD (Chronic Obstructive Pulmonary Disease); Emphysema; Minimally invasive

Outcome Measures

Primary Outcomes (3)

• Procedural and technical success - operatively

• Decrease in residual volume > 300mL from baseline

• Safety

Secondary Outcomes (4)

• Dyspnea scoring

• Pulmonary function measures

• Exercise tolerance

• Quality of life measures

Interventions

Exhale Drug-Eluting Stent DEVICE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• High resolution computed tomography (CT) scan evidence of bilateral emphysema
• Residual volume (RV) ≥ 220% predicted.
• Total lung capacity (TLC) ≥ 133% of predicted value.
• Forced expiratory volume (FEV1) \< 40% of predicted or FEV1 \< 1 liter.
• Marked dyspnea, scoring ≥ 2 on the modified Medical Research Council scale of 0-4.
• Patient has undergone pulmonary rehabilitation of 16 - 20 sessions.

You may not qualify if:

• FEV1 \> 20%
• Diffusing capacity for carbon monoxide (DLco) \< 15% of predicted.
• Respiratory infection requiring \> 3 hospitalizations in past year
• Inability to walk \> 140 meters in 6 minutes
• Giant bulla \> 1/3 of one lung's volume
• Previous lung volume reduction surgery (LVRS) or lobectomy.

Sponsors & Collaborators

• Broncus Technologies: lead

Study Sites (6)

The Prince Charles Hospital

Rode Road, Chermside, Queensland, 4032, Australia

Location

The Alfred Hospital

Prahran, Victoria, 3181, Australia

Location

Concord Repatriation General Hospital

Burwood, 2134, Australia

Location

Irmandade Santa Casa de Misericordia

Porto Alegre, 90020-090, Brazil

Location

Universitätsklinik des Saarlandes

Homburg, Saarland, 66421, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Related Links

• Broncus Technologies, Inc corporate web page
• American Lung Association

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Gregory I. Snell, MD

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2004
• Primary Completion: May 1, 2006
• Study Completion: May 1, 2006
• Last Updated: January 23, 2008

Record last verified: 2008-01

Locations

AU (3); BR (1); DE (2)