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Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00517998
First Posted: August 17, 2007
Last Update Posted: January 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Aeris Therapeutics
  Purpose
The purpose of this study is to evaluate the safety and efficacy of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema refractory to medical therapy.

Condition Intervention Phase
Pulmonary Emphysema Chronic Obstructive Pulmonary Disease Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema

Resource links provided by NLM:


Further study details as provided by Aeris Therapeutics:

Primary Outcome Measures:
  • SAEs - Safety of treatment and the procedure [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Reduction in gas trapping [ Time Frame: 12 weeks ]
  • Improvement in exercise capacity [ Time Frame: 12 weeks ]
  • Improvement in lung function (vital capacity) [ Time Frame: 12 weeks ]
  • Improvement in lung function (expiratory flow) [ Time Frame: 12 weeks ]
  • Improvement on dyspnea symptoms [ Time Frame: 12 weeks ]
  • Improvement in quality of life [ Time Frame: 12 weeks ]

Enrollment: 16
Study Start Date: May 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group1
Treatment will be administered in two sessions.
Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel
10 mL Hydrogel
Experimental: Group2
Treatment will be administered in a single session.
Drug: Biologic Lung Volume Reduction (BLVR) - 10 mL Hydrogel
10 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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of advanced 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
  • 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
  • significant comorbidity
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00517998


Locations
Israel
Rabin Medical Center
Petach Tivka, Israel, 49110
Sponsors and Collaborators
Aeris Therapeutics
Investigators
Principal Investigator: Yael Refaely, MD Rabin Medical Center
  More Information

Publications:
Responsible Party: Edward P Ingenito, MD, PhD, Medical Director & CSO, Aeris Therapeutics Inc
ClinicalTrials.gov Identifier: NCT00517998     History of Changes
Other Study ID Numbers: 01-C06-002
First Submitted: August 15, 2007
First Posted: August 17, 2007
Last Update Posted: January 18, 2010
Last Verified: January 2010

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

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


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