Biologic Lung Volume Reduction (BLVR) Phase 2 Homogeneous Study
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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 |
- reduction in gas trapping [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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 Pathologic Processes Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 16, 2013