Clinical trial NCT01181466: AeriSeal® System for Lung Volume Reduction in Patients With Advanced Emphysema
Official title: A 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: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pulmonary Emphysema
COPD
Lung Diseases
Keywords: PLVR
BLVR
AeriSeal
treatment
device
breathing
COPD
emphysema
polymeric lung volume reduction
biologic lung volume reduction
heterogeneous
homogeneous
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Aeris Therapeutics
Sponsor class: INDUSTRY
First posted: 2010-08-13
Enrollment: 20
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 procedural and post-procedural safety and efficacy of AeriSeal therapy at up to 4 subsegments during a single treatment session in patients with GOLD Stage III/IV homogeneous or heterogeneous emphysema.

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 a diagnosis of advanced emphysema as defined by FEV1/FVC\<70% predicted, FEV1 of \<50% predicted, TLC \> 100% predicted, and RV \> 135% predicted.
* Patients must have persistent symptoms despite medical therapy and either not be candidates for Lung Volume Reduction Surgery (LVRS) or have elected not to undergo LVRS.
* Patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the prespecified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Exclusion Criteria:

-

Primary outcomes:
measure: Change in Percent Volume of Lung
timeFrame: 12 weeks following treatment
Secondary outcomes:
measure: Change in the ratio of Residual Volume (RV) to Total Lung Capacity (TLC)
timeFrame: 12 weeks following treatment
measure: Change in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: 12 weeks following treatment
measure: Change in Forced Vital Capacity (FVC)
timeFrame: 12 weeks following treatment
measure: Change in distance walked in six minutes
timeFrame: 12 weeks following treatment
measure: Change in Medical Research Council Dyspnea (MRCD) score
timeFrame: 12 weeks following treatment
measure: Change in St. George's Respiratory Questionnaire (SGRQ) domain score
timeFrame: 12 weeks following treatment
Other outcomes:
Locations:
city: Beer Sheva
country: Israel
facility: The Soroka Medical Center
city: Petah Tikva
country: Israel
facility: The Rabin Medical Center
Study officials:
References:
citation: Magnussen H, Kramer MR, Kirsten AM, Marquette C, Valipour A, Stanzel F, Bonnet R, Behr J, Fruchter O, Refaely Y, Eberhardt R, Herth FJ. Effect of fissure integrity on lung volume reduction using a polymer sealant in advanced emphysema. Thorax. 2012 Apr;67(4):302-8. doi: 10.1136/thoraxjnl-2011-201038. Epub 2012 Feb 28.