US 10 mL 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:
NCT00435253
First received: February 7, 2007
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Pulmonary Emphysema
Biological: BLVR Treatment
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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 exercise capacity [ 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: 20
Study Start Date: February 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BLVR Treatment
BLVR Treatment
Biological: BLVR Treatment
BLVR Treatment, 10 mL Hydrogel

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.

  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 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)
  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: NCT00435253

Locations
United States, Alabama
University of Alabama Birmingham Lung Health Center
Birmingham, Alabama, United States, 35249
United States, Arizona
Pulmonary Associates
Phoenix, Arizona, United States, 85006
United States, Massachusetts
Caritas St Elizabeth's Med Cen
Boston, Massachusetts, United States, 02135
United States, Pennsylvania
Temple University Lung Center
Philadelphia, Pennsylvania, United States, 01940
United States, South Carolina
Medical University of South Carolina Hospital
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Aeris Therapeutics
Investigators
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: Mark Gotfried, MD Pulmonary Associates
Principal Investigator: Charlie Strange, MD Medical Univ South Carolina Hospital
Principal Investigator: Mark Dransfield, MD Univ of Alabama Birmingham Lung Health Center
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT00435253     History of Changes
Other Study ID Numbers: 01-C06-003
Study First Received: February 7, 2007
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Aeris Therapeutics:
emphysema
COPD
lung volume reduction
NETT
BLVR
biologic lung volume reduction
bronchoscopic lung volume reduction

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

ClinicalTrials.gov processed this record on September 22, 2014