Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Pulmonary Emphysema | Biological: BLVR Hydrogel | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Official Title: | Dose Escalation Study of the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System in Patients With Advanced Emphysema |
- Include: Product-related life-threatening adverse events, permanently disabling complications and deaths [ Time Frame: 1 year post treatment ]
- FEV1 [ Time Frame: 12 weeks post treatment ]
- MRC Dyspnea Score [ Time Frame: 12 weeks post treatment ]
- Six-Minute Walk Test [ Time Frame: 12 week post treatment ]
- Health-Related Quality of Life [ Time Frame: 12 week post treatment ]
- Include: Lung function tests [ Time Frame: 12 week post treatment ]
- Lung volume measurements [ Time Frame: 12 week post treatment ]
| Enrollment: | 5 |
| Study Start Date: | May 2005 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: single
BLVR Treatment
|
Biological: BLVR Hydrogel
10 mL BLVR Hydrogel
|
Detailed Description:
Emphysema is a progressive, debilitating disease that affects nearly 3 million people in the United States or roughly one percent of the US population. The disease is characterized by destruction of lung tissue as a result of inflammation caused by exposure to noxious inhaled agents for extended periods. The most common cause of this condition is cigarette smoking, although genetic and occupational causes account for up to 10% of cases. Despite aggressive public health initiatives aimed at discouraging the use of cigarettes, smoking-related lung diseases remain a significant cause of disability and death in the United States. Currently there are 46 million smokers in the US. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality in the United States for years to come.
Aeris has developed a novel bronchoscopic system for achieving the benefits of lung volume reduction without surgery. The Bronchoscopic Lung Volume Reduction (BLVR) Hydrogel System, a new investigational therapy for emphysema, is intended to reduce lung volume over a period of weeks by collapsing and promoting the remodeling of diseased areas of the lung. The resulting reduction in lung volume is intended to restore a more normal physiological relationship between lung and chest wall, improve breathing and exercise capacity and alleviate symptoms of chronic dyspnea. This study will evaluate the safety and efficacy of the Aeris BLVR System in patients with advanced emphysema.
Eligibility
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria include:
- Clinical diagnosis of advanced emphysema
- Age > 18 years at the time of initial presentation
- Clinically significant dyspnea (MRC Dyspnea >/= 2)
- Laboratory tests within protocol-specified ranges
- Pulmonary function tests
Exclusion Criteria include:
- Alpha-1 protease inhibitor deficiency verified by a serum level of <80mg% or knowledge of PI*ZZ genotype
- Tobacco use within 16 weeks of the initial clinic visit
- Body mass index < 15 kg/m2 or > 35 kg/m2
- Clinically significant asthma (reversible airway obstruction), chronic bronchitis or bronchiectasis
- Allergy to fish or pork products or sensitivity to tetracycline
- FEV1 <20% predicted with DLCO <20% predicted or homogeneous disease
Contacts and Locations
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00205920
| Netherlands | |
| St. Antonius Ziekenhuis | |
| Nieuwegein, Netherlands, 3430 EM | |
| Principal Investigator: | V.A.M. Duurkens, MD | St. Antonius Ziekenhuis |
More Information
Additional Information:
| Responsible Party: | Edward P Ingenito, MD, PhD, Medical Director & CSO, Aeris Therapeutics Inc |
| ClinicalTrials.gov Identifier: | NCT00205920 History of Changes |
| Other Study ID Numbers: |
C04-012 |
| First Submitted: | September 13, 2005 |
| First Posted: | September 21, 2005 |
| Last Update Posted: | January 18, 2010 |
| Last Verified: | January 2010 |
Keywords provided by Aeris Therapeutics:
|
emphysema pulmonary emphysema COPD COLD chronic obstructive pulmonary disease |
Additional relevant MeSH terms:
|
Emphysema Pulmonary Emphysema Pathologic Processes Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |