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

This study has been completed.
Sponsor:
Information provided by:
Aeris Therapeutics
ClinicalTrials.gov Identifier:
NCT00517998
First received: August 15, 2007
Last updated: January 14, 2010
Last verified: January 2010
  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: 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 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction in gas trapping [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in exercise capacity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in lung function (vital capacity) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in lung function (expiratory flow) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement on dyspnea symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Improvement in quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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: 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
Study First Received: August 15, 2007
Last Updated: January 14, 2010
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 29, 2014