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

Pulmonary Emphysema Clinical Trial

Official title:

Phase 1 Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Heterogeneous Emphysema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00085852
• Other study ID #: C04-001
• Secondary ID: IRB Protocol # 2
• Status: Completed
• Phase: Phase 1
• First received: June 15, 2004
• Last updated: February 27, 2008
• Start date: April 2005
• Est. completion date: June 2007

Study information

• Verified date: February 2008
• Source: Aeris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: June 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Biological:
• BLVR
10 mL Hydrogel

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Caritas St Elizabeth's Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Aeris Therapeutics

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. Epub 2002 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SAEs - Safety		1 year post treatment	Yes
Secondary	PFTs		12 weeks post treatment	No
Secondary	Dyspnea		12 weeks post treatment	No
Secondary	Exercise capacity		12 weeks post treatment	No
Secondary	QOL		12 weeks post treatment	No