US Biologic Lung Volume Reduction (BLVR) Phase 2 Emphysema Study
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Purpose
The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System in patients with advanced upper lobe predominant emphysema.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Emphysema Chronic Obstructive Pulmonary Disease |
Drug: Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized 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 System (BLVR) in Patients With Advanced Upper Lobe Predominant Emphysema |
- Reduction in gas trapping [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
- SAEs - Safety of treatment and the procedure [ Time Frame: 2 years post treatment ] [ Designated as safety issue: Yes ]
- Improvement in exercise capacity [ 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 expiratory flow [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
- Improvement in inspiratory flow [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
- Improvement in dyspnea symptoms (breathlessness) [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
- Improvement in respiratory quality of life [ Time Frame: 12 weeks post treatment ] [ Designated as safety issue: No ]
| Enrollment: | 22 |
| Study Start Date: | August 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Treatment will be administered in 2 treatment sessions.
|
Drug: Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel
20 mL Hydrogel
|
|
Experimental: Group 2
Treatment will be administered in a single treatment session.
|
Drug: Biologic Lung Volume Reduction (BLVR) - 20 mL Hydrogel
20 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 |
Inclusion Criteria:
- clinical diagnosis of advanced upper lobe 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
- homogeneous emphysema
- 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
- inability to tolerate bronchoscopy under conscious sedation (or anesthesia)
- history of renal infarction or renal failure
Contacts and Locations| 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, Ltd | |
| Topeka, Kansas, United States, 66606 | |
| United States, Maryland | |
| St Joseph's Medical Center | |
| Towson, Maryland, United States, 21204 | |
| United States, Ohio | |
| Akron Medical Center | |
| Akron, Ohio, United States, 44302 | |
| Pulmonary, Allergy & Critical Care Medicine, Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Temple University Lung Center | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Principal Investigator: | Geoffrey McLennan, MD | University of Iowa Hospitals & Clinics, Iowa City, IA |
| Principal Investigator: | Charlie Strange, MD | Medical University of South Carolina |
| Principal Investigator: | Mark Gotfried, MD | Pulmonary Associates, Phoenix, AZ |
| Principal Investigator: | Mark Krasna, MD | St Joseph's Medical Center, Towson, MD |
| Principal Investigator: | Sanjiv Tewari, MD | Akron Medical Center, Akron, OH |
| Principal Investigator: | Gerard Criner, MD | Temple University Lung Center, Philadelphia, PA |
| Principal Investigator: | William Leeds, DO | Veritas Clinical Specialties, Topeka, KS |
| Principal Investigator: | Thomas Gildea, MD | Pulmonary, Allergy & Critical Care Medicine, Cleveland Clinic, Cleveland, OH |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Aeris Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00515164 History of Changes |
| Other Study ID Numbers: | 01-C07-001 |
| Study First Received: | August 9, 2007 |
| Last Updated: | October 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Aeris Therapeutics:
|
lung volume reduction emphysema chronic obstructive pulmonary disease |
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 May 16, 2013