US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study

October 21, 2011 updated by: Aeris Therapeutics

Phase 2 Study of the Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema

Evaluate the efficacy and safety of the 10 mL BLVR System in 1 or 2 treatment sessions (8 subsegments, 4 in each lung) in patients with advanced upper lobe predominant emphysema.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, open-label, non-controlled, multi-center Phase 2 Study evaluating the efficacy and safety of the 10 mL BLVR System in patients with advanced upper lobe predominant emphysema. Twenty patients will be divided into 2 groups of 10 patients each and treated under conscious sedation at a total of 8 subsegments. Group 1 will be treated in 4 subsegments in 1 lung and have a second treatment of 4 subsegments in the other lung 6 to 12 weeks later. Group 2 will receive treatment at 8 subsegments (4 in each lung) during a single treatment session if possible; if not completed in 1 session the remaining subsegments will be treated 6 to 12 weeks later. Patients will be followed 96 weeks after completion of the final BLVR treatment. All patients will receive standard medical therapy in addition to BLVR treatment.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama Birmingham Lung Health Center
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Caritas St Elizabeth's Med Cen
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 01940
        • Temple University Lung Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Hospital

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

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • clinical diagnosis of advanced upper lobe predominant emphysema
  • age >/= 40 years
  • clinically significant dyspnea
  • failure of standard medical therapy to relieve symptoms (inhaled beta agonist and inhaled anticholinergic)
  • pulmonary function tests within protocol-specified ranges (post bronchodilator FEV1 < 45% predicted and experiencing < 30% or 300 mL improvement using bronchodilator; TLC > 110% predicted; RV > 150% predicted)
  • 6 Minute Walk Distance >/= 150 m

Exclusion Criteria:

  • alpha-1 protease inhibitor deficiency
  • homogeneous disease
  • tobacco use within 4 months of initial visit
  • body mass index < 15 kg/m2 or > 35 kg/m2
  • clinically significant asthma, chronic bronchitis or bronchiectasis
  • allergy or sensitivity to procedural components
  • pregnant, lactating or unwilling to use birth control if required
  • prior lung volume reduction surgery, lobectomy, pneumonectomy, lung transplant, endobronchial valve placement, airway stent placement or pleurodesis
  • comorbid condition that could adversely influence outcomes
  • inability to tolerate bronchoscopy under conscious sedation (or anesthesia)

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: BLVR Treatment
Biological: BLVR Treatment
BLVR Treatment, 10 mL Hydrogel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in gas trapping
Time Frame: 12 weeks post treatment
12 weeks post treatment
SAEs - Safety of treatment and the procedure
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in exercise capacity
Time Frame: 12 weeks post treatment
12 weeks post treatment
Improvement in vital capacity
Time Frame: 12 weeks post treatment
12 weeks post treatment
Improvement in expiratory flow
Time Frame: 12 weeks post treatment
12 weeks post treatment
Improvement in inspiratory flow
Time Frame: 12 weeks post treatment
12 weeks post treatment
Improvement in dyspnea symptoms (breathlessness)
Time Frame: 12 weeks post treatment
12 weeks post treatment
Improvement in respiratory quality of life
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: Mark Gotfried, MD, Pulmonary Associates
  • Principal Investigator: Victor Pinto-Plata, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.
  • Principal Investigator: Gerard Criner, MD, Temple University Lung Center
  • Principal Investigator: Charlie Strange, MD, Medical Univ South Carolina Hospital
  • Principal Investigator: Mark Dransfield, MD, Univ of Alabama Birmingham Lung Health Center

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

February 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

February 7, 2007

First Submitted That Met QC Criteria

February 12, 2007

First Posted (Estimate)

February 14, 2007

Study Record Updates

Last Update Posted (Estimate)

October 24, 2011

Last Update Submitted That Met QC Criteria

October 21, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01-C06-003

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.

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