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Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT00630227
First received: February 27, 2008
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

The purpose of the study is to evaluate the efficacy and safety of the 20 mL BLVR System in patients with homogeneous emphysema. Patients with upper lobe predominant emphysema initially screened for earlier Phase 2 studies but not enrolled before study enrollment closed are also eligible for participation.


Condition Intervention Phase
Homogeneous Emphysema
Biological: Biologic Lung Volume Reduction
Phase 2

Study Type: Interventional
Study Design: 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 (BLVR) System in Patients With Homogeneous or 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 ]

Secondary Outcome Measures:
  • improvement in exercise 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 vital capacity [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • improvement in dyspnea sysmptoms [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • improvemnet in respiratory quality of life [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
  • serious adverse events [ Time Frame: through 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 33
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single
all patients are treated with the experimental therapy
Biological: Biologic Lung Volume Reduction
20 mL Hydrogel

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. In recent years, lung volume reduction surgery has become an accepted therapy for advanced emphysema. Lung volume reduction surgery (LVRS) involves the removal of diseased portions of the lung in order to enable the remaining, healthier portions of the lung to function better. LVRS, 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 or in the case of homogeneous disease, areas that are less active as shown by the extent of regional blood flow. 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 treated areas of the lung. This provides room within the chest to allow the remaining 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 (upper lobe predominant) 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 homogeneous or upper lobe predominant emphysema demonstrated by CT scan
  • age >/= 40 years
  • clinically significant dyspnea
  • failure of standard medical therapy (typically inhaled beta agonist & inhaled anticholinergic) to relieve symptoms
  • 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:

  • tobacco use within 4 months of initial visit or during study
  • 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 lung perfusion scan indicating > 20% of blood flow to either upper lung field or 30% total to both upper lung fields if homogeneous emphysema
  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: NCT00630227

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249
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
Topeka, Kansas, United States, 66606
United States, Maryland
St Josephs Medical Center
Towson, Maryland, United States, 21204
United States, Ohio
Akron Medical Center
Akron, Ohio, United States, 44302
Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Temple University Lung Center
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Aeris Therapeutics
Investigators
Principal Investigator: Mark Gotfried, MD Pulmonary Associates, Phoenix, AZ
Principal Investigator: Mark Dransfield, MD University of Alabama, Birmingham, AL
Principal Investigator: Gerard Criner, MD Temple University Lung Center, Philadelphia, PA
Principal Investigator: William Leeds, DO Veritas Clinical Specialties, Topeka, KS
Principal Investigator: Mark Krasna, MD St Josephs Medical Center, Towson, MD
Principal Investigator: Thomas Gildea, MD Cleveland Clinic, Cleveland, OH
Principal Investigator: Sanjiv Tewari, MD Akron Medical Center, Akron, OH
Principal Investigator: Geoffrey McLennan, MD University of Iowa Hospitals & Clinics, Iowa City, IA
  More Information

Publications:
Responsible Party: Aeris Therapeutics
ClinicalTrials.gov Identifier: NCT00630227     History of Changes
Other Study ID Numbers: 01-C07-002
Study First Received: February 27, 2008
Last Updated: October 21, 2011
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014