US 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study - Initial Formulation

Phase 1

Completed

• Conditions: Pulmonary Emphysema
• Interventions: Biological: BLVR

• Registration Number: NCT00085852
• Lead Sponsor: Aeris Therapeutics

Brief Summary

The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.

Detailed Description

Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. Recently, lung volume reduction surgery has become an accepted therapy for emphysema. Lung volume reduction surgery involves the removal of a diseased portion of the lung, which enables the remaining, healthier portions of the lung to function better. This procedure, although effective, is complicated and risky.

Aeris Therapeutics has developed the Aeris Bronchoscopic Lung Volume Reduction System for treatment of patients with advanced emphysema. The Aeris BLVR System is designed to reduce lung volume without surgery. Patients are treated under anesthesia using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment is expected to reduce lung volume by shrinking the diseased areas of the lung. The purpose of the current study is to find out whether the Aeris BLVR System is safe in patients with advanced emphysema. The risks associated with the treatment are expected to be similar to those associated with general anesthesia and bronchoscopy.

Study Timeline

• Study First Submitted: 2004-06-15
• Study First Submitted QC: 2004-06-16
• Study First Posted: 2004-06-17
• Study Start: 2005-04
• Primary Completion: 2006-10
• Study Completion: 2007-06
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-27
• Last Update Posted: 2008-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Advanced emphysema
• Limited exercise capacity and persistent symptoms despite medical therapy
• Age between 18 and 75
• No significant heart, kidney or liver disease
• Willingness and ability to tolerate bronchoscopy
• No prior Lung Volume Reduction Surgery or Lung Transplantation
• Screening test results indicating that the procedure is appropriate

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	BLVR	Treatment with BLVR

Primary Outcome Measures

Name	Time	Method
SAEs - Safety	1 year post treatment

Secondary Outcome Measures

Name	Time	Method
Dyspnea	12 weeks post treatment
PFTs	12 weeks post treatment
Exercise capacity	12 weeks post treatment
QOL	12 weeks post treatment

Trial Locations

Locations (2)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Caritas St Elizabeth's Medical Center; 🇺🇸 Boston, Massachusetts, United States