Clinical trial NCT00347659: US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study
Official title: Phase 1 Study of the Biologic Lung Volume Reduction (BLVR) System in Patients With Advanced Upper Lobe Predominant Emphysema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pulmonary Emphysema
Keywords: Lung volume reduction
Bronchoscopy
Emphysema
COPD
NETT
Lung disease
COLD
BLVR
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2006-07-04
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety of the Biologic Lung Volume Reduction System (BLVR) for patients with advanced emphysema.

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 Biologic Lung Volume Reduction (BLVR) 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 of the BLVR System in patients with advanced emphysema.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of advanced heterogeneous emphysema
* Age \>/= 40
* Clinically significant dyspnea
* Failure of standard medical therapy to relieve symptoms
* Pulmonary function tests with protocol-specified ranges

Exclusion Criteria:

* Alpha-1 protease inhibitor deficiency
* Tobacco use within 16 weeks of initial clinic visit
* Body mass index \< 15 kg/m2 or \> 35 kg/m@
* Clinically significant asthma, chronic bronchitis or bronchiectasis
* Allergy or sensitivity to tetracycline
* Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior endobronchial valve placement, prior airway stent placement or prior pleurodesis

Primary outcomes:
measure: SAEs - Safety of the procedure from initiation of treatment through hospital discharge.
timeFrame: 1 week post treatment
measure: SAEs - Safety of the treatment through Week 12.
timeFrame: 12 weeks post procedure
Secondary outcomes:
measure: SAEs - Safety of the treatment through Week 48.
timeFrame: 48 weeks post treatment
measure: Evaluation of radiologic changes.
timeFrame: 12 weeks post treatment
measure: Improvement in exercise capacity.
timeFrame: 12 weeks post treatment
measure: Improvement in quality of life.
timeFrame: 12 weeks post treatment
measure: Decrease in trapped gas.
timeFrame: 12 weeks post treatment
measure: Improvement in lung function.
timeFrame: 12 weeks post trreatment
measure: Improvement in symptoms.
timeFrame: 12 weeks post treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Caritas St. Elizabeth's Medical Center
state: Massachusetts
city: Philadelphia
country: United States
facility: Temple University Lung Center
state: Pennsylvania
Study officials:
References:
citation: Ingenito EP, Berger RL, Henderson AC, Reilly JJ, Tsai L, Hoffman A. Bronchoscopic lung volume reduction using tissue engineering principles. Am J Respir Crit Care Med. 2003 Mar 1;167(5):771-8. doi: 10.1164/rccm.200208-842OC. Epub 2002 Oct 11.