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

February 27, 2008 updated by: Aeris Therapeutics

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02135
        • Caritas St Elizabeth's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single
Treatment with BLVR
Biological: BLVR
10 mL Hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SAEs - Safety
Time Frame: 1 year post treatment
1 year post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
PFTs
Time Frame: 12 weeks post treatment
12 weeks post treatment
Dyspnea
Time Frame: 12 weeks post treatment
12 weeks post treatment
Exercise capacity
Time Frame: 12 weeks post treatment
12 weeks post treatment
QOL
Time Frame: 12 weeks post treatment
12 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aeris Therapeutics

Investigators

  • Principal Investigator: John J. Reilly, MD, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

June 15, 2004

First Submitted That Met QC Criteria

June 16, 2004

First Posted (Estimate)

June 17, 2004

Study Record Updates

Last Update Posted (Estimate)

March 6, 2008

Last Update Submitted That Met QC Criteria

February 27, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C04-001
  • IRB Protocol # 2003-P-002171

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Emphysema

Clinical Trials on BLVR

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Brazil

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe