Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- SAEs - Safety of treatment and the procedure [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- 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 |
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 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 May 16, 2013