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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT00515164
First received: August 9, 2007
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System in patients with advanced upper lobe predominant emphysema.


Condition Intervention Phase
Pulmonary Emphysema
Chronic Obstructive Pulmonary Disease
Drug: Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of the 20 mL Biologic Lung Volume Reduction System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • Reduction in gas trapping [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • SAEs - Safety of treatment and the procedure [ Time Frame: 2 years post treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in exercise capacity [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Improvement in vital capacity [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Improvement in expiratory flow [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Improvement in inspiratory flow [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Improvement in dyspnea symptoms (breathlessness) [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Improvement in respiratory quality of life [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]

Enrollment: 22
Study Start Date: August 2007
Study Completion Date: December 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Treatment will be administered in 2 treatment sessions.
Drug: Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel
20 mL Hydrogel
Experimental: Group 2
Treatment will be administered in a single treatment session.
Drug: Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel
20 mL Hydrogel

Detailed Description:

Background:

Patients with emphysema currently have limited treatment choices. Many patients are treated with steroids and inhaled medications, which often provide little or no benefit. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. This procedure, although effective for many patients, is complicated and is accompanied by substantial morbidity and mortality risk.

Aeris Therapeutics has developed the Biologic Lung Volume Reduction (BLVR) System which is intended to achieve lung volume reduction without surgery and its attendant risks. Patients are treated using a bronchoscope to direct treatment to the most damaged areas of the lung. The treatment delivers a precisely proportioned proprietary mixture of drugs and biologics which, when combined at the treatment site, form a biodegradable hydrogel. The hydrogel acts to reduce lung volume by permanently collapsing and sealing the diseased areas of the lung. This provides room within the chest to allow the remaining healthier portions of the lung to function better.

Aeris' BLVR development program has been granted Fast Track designation by the U.S. FDA, and is the subject of ongoing clinical trials designed to investigate the safety and efficacy of the BLVR System as a treatment for patients with advanced heterogeneous emphysema. Fast Track designation is reserved for drug and biologic development programs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • alpha-1 protease inhibitor deficiency
  • homogeneous emphysema
  • 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, endotracheal valve placement, airway stent placement or pleurodesis
  • comorbid condition that could adversely influence outcomes
  • inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
  • history of renal infarction or renal failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515164

Locations
United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
United States, Kansas
Veritas Clinical Specialties, Ltd
Topeka, Kansas, United States, 66606
United States, Maryland
St Joseph's Medical Center
Towson, Maryland, United States, 21204
United States, Ohio
Akron Medical Center
Akron, Ohio, United States, 44302
Pulmonary, Allergy & Critical Care Medicine, Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Temple University Lung Center
Philadelphia, Pennsylvania, United States, 19140
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Aeris Therapeutics
Investigators
Principal Investigator: Geoffrey McLennan, MD University of Iowa Hospitals & Clinics, Iowa City, IA
Principal Investigator: Charlie Strange, MD Medical University of South Carolina
Principal Investigator: Mark Gotfried, MD Pulmonary Associates, Phoenix, AZ
Principal Investigator: Mark Krasna, MD St Joseph's Medical Center, Towson, MD
Principal Investigator: Sanjiv Tewari, MD Akron Medical Center, Akron, OH
Principal Investigator: Gerard Criner, MD Temple University Lung Center, Philadelphia, PA
Principal Investigator: William Leeds, DO Veritas Clinical Specialties, Topeka, KS
Principal Investigator: Thomas Gildea, MD Pulmonary, Allergy & Critical Care Medicine, Cleveland Clinic, Cleveland, OH
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT00515164     History of Changes
Other Study ID Numbers: 01-C07-001
Study First Received: August 9, 2007
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Aeris Therapeutics:
lung volume reduction
emphysema
chronic obstructive pulmonary disease

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Emphysema
Pulmonary Emphysema
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 30, 2014