Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study - Full Text View

Sponsored by:	Aeris Therapeutics
Information provided by:	Aeris Therapeutics
ClinicalTrials.gov Identifier:	NCT00630227

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 II

MedlinePlus related topics: Emphysema

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Study of the 20 mL Biologic Lung Volume Reduction (BLVR) System in Patients With Homogeneous or Upper Lobe Predominant Emphysema

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
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single: Experimental 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

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
Cleveland Clinic Foundation, Pulmonary Allergy & Critical Care Medicine
Cleveland, Ohio, United States, 44195
Akron Medical Center
Akron, Ohio, United States, 44302
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:

Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. Epub 2002 Oct 11.

Reilly J, Washko G, Pinto-Plata V, Velez E, Kenney L, Berger R, Celli B. Biological Lung Volume Reduction*A New Bronchoscopic Therapy for Advanced Emphysema. Chest. 2007 Apr;131(4):1108-1113.

Responsible Party:	Aeris Therapeutics Inc ( Edward P Ingenito, MD, PhD, Medical Director & CSO )
Study ID Numbers:	01-C07-002
Study First Received:	February 27, 2008
Last Updated:	July 17, 2008
ClinicalTrials.gov Identifier:	NCT00630227
Health Authority:	United States: Food and Drug Administration

Keywords provided by Aeris Therapeutics:

emphysema
chronic obstructive pulmonary disease
lung volume reduction

Study placed in the following topic categories:

Pulmonary Emphysema
Emphysema
Lung Diseases, Obstructive

Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009