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US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

This study has been completed.
Sponsor:
Information provided by:
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT00347659
First received: June 30, 2006
Last updated: February 27, 2008
Last verified: February 2008
History of Changes
  Purpose

The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.


Condition Intervention Phase
Pulmonary Emphysema
 Drug: BLVR System
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Emphysema
U.S. FDA Resources

Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • SAEs - Safety of the procedure from initiation of treatment through hospital discharge. [ Time Frame: 1 week post treatment ] [ Designated as safety issue: Yes ]
  • SAEs - Safety of the treatment through Week 12. [ Time Frame: 12 weeks post procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • SAEs - Safety of the treatment through Week 48. [ Time Frame: 48 weeks post treatment ] [ Designated as safety issue: Yes ]
  • Evaluation of radiologic changes. [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Improvement in exercise capacity. [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Improvement in quality of life. [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Decrease in trapped gas. [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • Improvement in lung function. [ Time Frame: 12 weeks post trreatment ] [ Designated as safety issue: No ]
  • Improvement in symptoms. [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: June 2006
Study Completion Date: September 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Treatment
Experimental Treatment
 Drug: BLVR System
Treatment is administered in a single treatment session.

Detailed Description:

Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.

Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Biologic Lung Volume Reduction (BLVR) System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety of the BLVR System in patients with advanced emphysema.

  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 heterogeneous emphysema
  • Age >/= 40
  • Clinically significant dyspnea
  • Failure of standard medical therapy to relieve symptoms
  • Pulmonary function tests with protocol-specified ranges

Exclusion Criteria:

  • Alpha-1 protease inhibitor deficiency
  • Tobacco use within 16 weeks of initial clinic visit
  • Body mass index < 15 kg/m2 or > 35 kg/m@
  • Clinically significant asthma, chronic bronchitis or bronchiectasis
  • Allergy or sensitivity to tetracycline
  • Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347659

Locations
United States, Massachusetts
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135
United States, Pennsylvania
Temple University Lung Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Aeris Therapeutics
  More Information

Publications:

Responsible Party: Edward Ingenito, MD, PhD, Medical Director &CSO, Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT00347659     History of Changes
Other Study ID Numbers: 01-C06-001
Study First Received: June 30, 2006
Last Updated: February 27, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Aeris Therapeutics:
Lung volume reduction
Bronchoscopy
Emphysema
COPD
 NETT
Lung disease
COLD
BLVR

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013