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

February 27, 2008
October 21, 2011
February 2008
December 2009   (final data collection date for primary outcome measure)
reduction in gas trapping [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00630227 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study
Phase 2 Study of the 20 mL Biologic Lung Volume Reduction (BLVR) System in Patients With Homogeneous or Upper Lobe Predominant Emphysema

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Homogeneous Emphysema
Biological: Biologic Lung Volume Reduction
20 mL Hydrogel
Experimental: Single
all patients are treated with the experimental therapy
Intervention: Biological: Biologic Lung Volume Reduction

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00630227
01-C07-002
No
Aeris Therapeutics
Aeris Therapeutics
Not Provided
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
Aeris Therapeutics
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP