Clinical trial NCT01320566: A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema
Official title: A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Pulmonary Emphysema
Chronic Obstructive Pulmonary Disease(COPD)
Lung Diseases
Keywords: Polymeric Lung Volume Reduction (PLVR)
Bolilogic Lung Volume Reduction (BLVR)
AeriSeal
treatment
device
breathing
COPD
emphysema
heterogeneous
homogeneous
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 18
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 assess the long term safety and efficacy of AeriSeal System treatment administered at up to 4 subsegments during a single treatment session for lung volume reduction in patients with advanced emphysema through 48 weeks after treatment.

Detailed description: Emphysema is a progressive, debilitating disease 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, occupational, and environmental 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 worldwide. Due to the number of current and new smokers, emphysema is expected to remain a leading cause of morbidity and mortality for years to come.

The AeriSeal System is a novel device system being developed for the treatment of advanced emphysema. The AeriSeal System is administered bronchoscopically, and designed to provide the physiological benefits of lung volume reduction without the risks and cost of major surgery.

Eligibility criteria: Inclusion Criteria:

* Patients must have been enrolled in the 03-C10-002PLV Aeris' Investigational Study and completed a minimum of 12 weeks of follow-up following AeriSeal System treatment.

Primary outcomes:
measure: Change from baseline in Percent Volume of Lung
timeFrame: 48 Weeks following treatment
Secondary outcomes:
measure: Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)
timeFrame: 24 and 48 weeks following treatment
measure: Change in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 24 and 48 weeks following treatment
measure: Change in Forced Vital Capacity (FVC)
timeFrame: 24 and 48 weeks following treatment
measure: Change in distance walked in six minutes
timeFrame: 24 and 48 weeks following treatment
measure: Change in Medical Research Council Dyspnea (MRCD) score
timeFrame: 24 and 48 weeks following treatment
measure: Change in St. George's Respiratory Questionnaire (SGRQ)domain score
timeFrame: 24 and 48 weeks following treatment
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: The Soroka Medical Center
city: Petach Tikva
country: Israel
facility: The Rabin Medical Center
Study officials:
References: